WEBVTT 1 00:00:20.700 --> 00:00:31.740 Rebekah Horowitz (she/her): Hello everyone's Rebecca we will get started in just about one to two minutes depending on when it stops looking like people are rapidly entering the room. 2 00:01:49.530 --> 00:01:54.780 Rebekah Horowitz (she/her): just going to give it another like 30 seconds, because the numbers are still rapidly going up. 3 00:02:28.140 --> 00:02:32.010 Rebekah Horowitz (she/her): Okay let's get started. 4 00:02:33.480 --> 00:02:51.390 Rebekah Horowitz (she/her): Hello everyone, welcome to our co hosted webinar between NATO NASA and CSD we're really excited to share this webinar as an STI testing where we're talking about new point of care advances and why this is helpful for the local public health. 5 00:02:52.410 --> 00:03:00.300 Rebekah Horowitz (she/her): or public health in general across the country, my name is Rebecca Horowitz and I met NATO as i'm just going to kick us off. 6 00:03:01.740 --> 00:03:04.260 Rebekah Horowitz (she/her): Our agenda for the day. 7 00:03:05.670 --> 00:03:13.110 Rebekah Horowitz (she/her): we're already in the welcome i'll talk briefly about rising rates of St eyes and I will turn it over to. 8 00:03:13.680 --> 00:03:27.510 Rebekah Horowitz (she/her): Dr skolnick who will talk about traditional STI testing methods and challenges benefits presented by point of care testing the impact on health department services and care with point of care testing and then we'll have some time for Q amp a. 9 00:03:29.760 --> 00:03:36.150 Rebekah Horowitz (she/her): Again, our speakers today i'm Rebecca Horwitz i'm with the National Association of county and city health officials. 10 00:03:36.420 --> 00:03:42.510 Rebekah Horowitz (she/her): We have Gary skolnik chief medical officer for busy medical, as well as a professor of medicine at Stanford university. 11 00:03:42.840 --> 00:03:55.890 Rebekah Horowitz (she/her): And Jennifer man national the National Coalition for STD directors, we will also have Angela Johnson with next dad who will be moderating the Q amp a so as questions come up please put them into the Q amp a box. 12 00:03:56.190 --> 00:04:03.960 Rebekah Horowitz (she/her): Angela as well as her colleague Krupa will be keeping an eye on that, so that we can move through those few and any questions quickly at the end. 13 00:04:06.240 --> 00:04:09.330 Rebekah Horowitz (she/her): So i'm just going to do some setting up the stage some level setting. 14 00:04:11.100 --> 00:04:21.600 Rebekah Horowitz (she/her): So, prevention and control of STI is is generally based on five major strategies those strategies include accurate risk assessment and education and counseling of persons that risk. 15 00:04:22.050 --> 00:04:31.050 Rebekah Horowitz (she/her): Pre exposure vaccination for vaccine preventable STI identification of a semi automatically ineffective persons and persons with with. 16 00:04:31.590 --> 00:04:45.240 Rebekah Horowitz (she/her): That should say symptoms not systems effective diagnosis, treatment counseling and follow up for infected persons and evaluation treatment and counseling of sex partners of persons who are infected with an STI. 17 00:04:46.110 --> 00:04:54.420 Rebekah Horowitz (she/her): So when we think about all of these major strategies there's a lot that can happen between the time that someone goes into the clinic to get tested. 18 00:04:54.780 --> 00:05:03.360 Rebekah Horowitz (she/her): And when they actually get their results that would that would impact their ability to participate in these strategies and so that's really why we wanted to talk about these new. 19 00:05:03.630 --> 00:05:13.170 Rebekah Horowitz (she/her): developments and point of care testing and how they would impact the ability to speed up some of these strategies are you the use of some of these strategies. 20 00:05:15.360 --> 00:05:22.290 Rebekah Horowitz (she/her): So rising rates of reportable St is this is probably familiar to many on the webinar but in. 21 00:05:23.250 --> 00:05:36.240 Rebekah Horowitz (she/her): The CDC surveillance data showed us that 1.8 million cases of chlamydia are reported to the CDC, making it the most common notifiable condition and the United States in 2019. 22 00:05:36.840 --> 00:05:46.440 Rebekah Horowitz (she/her): That corresponds with a rate of fifth of 552.8 cases per hundred thousand and the population or an increase of 2.8% from. 23 00:05:48.120 --> 00:05:55.650 Rebekah Horowitz (she/her): Those rates also increased among males and females and all regions of the United States and among all racial and ethnic groups. 24 00:05:56.730 --> 00:06:08.970 Rebekah Horowitz (she/her): Similarly forgot to Rio, there was an increase, we had over 600,000 cases of gonorrhea reported, making it the second most common notifiable condition in the United States. 25 00:06:09.540 --> 00:06:19.860 Rebekah Horowitz (she/her): They are the rates have increased 92% since their historic low in 2009 and, overall, the rate increased 5.7% from actually from. 26 00:06:21.990 --> 00:06:28.080 Rebekah Horowitz (she/her): Rates increase among males and females in all regions and among all racial and ethnic groups. 27 00:06:30.600 --> 00:06:40.590 Rebekah Horowitz (she/her): And again, this was the six consecutive year of record breaking STD cases for those reportable STDs of us that CDC puts out an STD surveillance report. 28 00:06:42.930 --> 00:06:46.290 Rebekah Horowitz (she/her): So far, disparities and reportable STDs and. 29 00:06:47.610 --> 00:06:57.330 Rebekah Horowitz (she/her): Over half 55.4% of reported cases of STDs reported to the CD to CDC were among adolescents and young adults, aged 15 to 24. 30 00:06:58.170 --> 00:07:08.820 Rebekah Horowitz (she/her): And 30.6% of all cases of chlamydia gonorrhea i'm guessing that's 36 who this is trouble so i'm sorry about that mistake. 31 00:07:09.390 --> 00:07:28.890 Rebekah Horowitz (she/her): Of all cases of chlamydia gonorrhea and syphilis 36 yes 36% of all cases of chlamydia gonorrhea and syphilis were among non Hispanic blacks, even though they represent only 12 about 12.5% of the population MSM or men who have sex with men were also disproportionately impacted. 32 00:07:30.840 --> 00:07:42.750 Rebekah Horowitz (she/her): We also wanted to talk about trick so trick is not a condition that is required to be reported to the CDC and as a result, it is likely both under-diagnosed and, of course, under reported. 33 00:07:43.260 --> 00:07:56.550 Rebekah Horowitz (she/her): CDC recommends testing for trick and all women are all people having vaginas seeking treatment for vaginal discharge and 70 to 85% of trick occurs as an asymptomatic and women. 34 00:07:57.780 --> 00:08:07.080 Rebekah Horowitz (she/her): So CDC is recommending that you test for trick only when there are symptoms but 70 to 85% of truck occurs without symptoms. 35 00:08:07.950 --> 00:08:23.220 Rebekah Horowitz (she/her): And just one more piece of evidence on why it would be under diagnosed and under reported and trick increases the risk of contracting HIV by two to 3% So if you look at this chart here for estimates for prevalence and incidents in. 36 00:08:24.600 --> 00:08:37.380 Rebekah Horowitz (she/her): You see, that the estimates are that trick is actually um there are more incidents of truck occurring then committee or gonorrhea even though Those are our most reported notifiable diseases. 37 00:08:40.380 --> 00:08:49.740 Rebekah Horowitz (she/her): So i'm going to turn it over here so Dr school next to talk about traditional STI testing and the challenges that presents and then point of care testing. 38 00:08:52.200 --> 00:09:02.460 Gary: Thank you very much Rebecca for that excellent summary of the current epidemiology of these St is may have the first slide please. 39 00:09:04.560 --> 00:09:06.210 Gary: i'm going to be speaking about. 40 00:09:07.290 --> 00:09:16.770 Gary: The impact of point of care diagnostics at affecting the undertreatment rates and overtreatment rates for STDs. 41 00:09:18.690 --> 00:09:25.260 Gary: May in this first part of the presentation i'd like to present a case to you, could you please turn to the next slide. 42 00:09:27.240 --> 00:09:38.250 Gary: This is the case of Mrs Smith, who presents to the county sexual health clinic her chief complaint was increase in her vaginal discharge in 10 days duration and most prominently. 43 00:09:38.820 --> 00:09:50.130 Gary: concerned about having a new sexual partner in a relationship that began two weeks before her past medical history is significant for a positive HPV DNA test one year ago. 44 00:09:50.790 --> 00:09:58.680 Gary: One episode of bacterial vaginosis eight months ago, three episodes of urinary tract infections during the past three years. 45 00:09:59.430 --> 00:10:09.270 Gary: and on her annual screening tests last administered 11 months ago she tested negative for the Ghana Caucus committee of syphilis and HIV. 46 00:10:09.870 --> 00:10:29.820 Gary: And as we go through this talk i'll be using n g to signify nice Syria gotta read it and CT for committee trichomonas and TV for trichomonas badge and a was her clinical course was as follows the triage nurse at the clinic focusing on Mrs smith's concerned about a new sexual partner. 47 00:10:33.090 --> 00:10:43.920 Gary: Had the patient collect a vaginal swab the swab was sent to a central lab and then a complete medical history and pelvic exam was performed on next slide please. 48 00:10:47.880 --> 00:11:00.780 Gary: Here is the journey that vaginal swab sample took it was collected on day one, as you can see, on the Left eye it reached the central lab within about 18 hours. 49 00:11:01.830 --> 00:11:09.210 Gary: A result was obtained by the central lab on day 372 hours after the Mrs Smith presented to this clinic. 50 00:11:10.200 --> 00:11:19.500 Gary: There were three attempts to contact the patient, on the third attempt it was successful and the patient returned to the clinic and was treated on day seven. 51 00:11:20.310 --> 00:11:35.130 Gary: So, if we look up that vaginal swab sample to sample to result at the central lab took 72 hours, the sample to treatment, which is what really matters of course took 168 hours may we have the next slide please. 52 00:11:38.010 --> 00:11:49.140 Gary: The physician upon seeing Mrs Smith and hearing her history and conducting the pelvic exam elected not to treat her due to the absence of compelling symptoms. 53 00:11:50.070 --> 00:12:05.520 Gary: or physical exam signs 72 hours later, the central lab reported that they had detected the gun a Caucus This therefore is an example of either under treatment or, more specifically, in this case delayed treatment next slide please. 54 00:12:07.830 --> 00:12:15.960 Gary: So let's review this once again in the context of that delayed treatment, so, as you can see, on the red arrow on the left. 55 00:12:16.590 --> 00:12:28.830 Gary: Mrs Smith had this vegetable swag collection on day one, the result was obtained on day three was positive for the Caucus and then she only returned clinic and had the. 56 00:12:29.970 --> 00:12:37.740 Gary: correct treatment intra muscular cf try X zone on day seven so there was a seven day delay in treatment. 57 00:12:38.970 --> 00:12:41.430 Gary: In this case, next slide please. 58 00:12:42.990 --> 00:13:00.840 Gary: What are the consequences of undertreatment or delayed treatment of an STD well i'd like to review them with you here first consequence onward transmission of an STD pathogen and thus propagation of the epidemic if the individual continues to have sexual relations. 59 00:13:02.010 --> 00:13:12.060 Gary: delayed a treatment results in the possibility that you will be complications of progressive infection, particularly in the case of the Ghana Caucus and of chlamydia. 60 00:13:12.750 --> 00:13:18.570 Gary: And it is possible in that seven day period the organism could proceed from the end of cervical Canal. 61 00:13:19.080 --> 00:13:25.410 Gary: On to the endometrial surface in into the fallopian tubes resulting in pelvic inflammatory disease. 62 00:13:26.040 --> 00:13:35.490 Gary: With a well known complications of that being in fertility ectopic pregnancy and chronic pelvic pain obviously there's a delay in the expedited partner treatment. 63 00:13:36.150 --> 00:13:49.110 Gary: That could have occurred more more quickly had to resolve return more quickly there's a reduced opportunity for what I call result enabled face to face condition patient dialogue. 64 00:13:51.420 --> 00:14:00.990 Gary: inefficient clinic workflow also would result because the staff needs to contact the patient by phone and that's often problematic, as you all know. 65 00:14:01.860 --> 00:14:07.710 Gary: And schedule for a return appointment there's reduced patient satisfaction because the patient leaves the. 66 00:14:08.580 --> 00:14:24.540 Gary: clinic on the initial clinic visit without a precise diagnosis and there's obviously reduce condition satisfaction because the clinician does not have a result that drives a result specific kind of intervention next slide please. 67 00:14:27.000 --> 00:14:34.320 Gary: scenario be, which is the same patient Mrs Smith, but in this case, an example of overtreatment of an STD. 68 00:14:35.190 --> 00:14:47.460 Gary: Here the the clinician lex to treat before lab results are provided for the veggie night is syndrome, because the patient complained of a slight discharge in her normal vegetable discharge. 69 00:14:48.270 --> 00:14:58.680 Gary: Based on that assumption the patient received metro night so early for seven days for treatment of possible bacterial vaginosis and trichomonas veggie nameless. 70 00:14:59.310 --> 00:15:12.870 Gary: 72 hours later, the central lab recorded that the testing they did was negative for the gunner Caucus negative for commedia negative negative for trichomonas and negative for bacterial vaginosis. 71 00:15:13.590 --> 00:15:22.200 Gary: dust, this would have been an example of overtreatment up an STD since the patient received met rhinitis all based on an empirical. 72 00:15:24.870 --> 00:15:30.480 Gary: view by the clinician that she had a either bacterial veggie nails. 73 00:15:31.860 --> 00:15:41.760 Gary: or trick trick and bonus next slide please, what are the exam consequences of overtreatment of an STD well, of course, there's. 74 00:15:42.810 --> 00:15:53.730 Gary: Unnecessary exposure of the patient to a medication, leading to possible adverse effects, as you all know, metro ny to sell sometimes is associated with. 75 00:15:55.020 --> 00:16:01.230 Gary: dysphoria and nausea and many other very unpleasant symptoms on the part of patients. 76 00:16:02.070 --> 00:16:10.830 Gary: There is the possibility of selection of antibiotic resistant micro organisms that's contributing to the further emergence of antibiotic resistant infections. 77 00:16:11.370 --> 00:16:17.040 Gary: Does this is concerned, it grows out of the antibiotic stewardship Program. 78 00:16:17.790 --> 00:16:31.680 Gary: there's ineffective or misleading clinician patient dialogue because the discuss discussion with the patient on the initial clinic visit will be biased by an incorrect diagnosis, for example, the doctor would have. 79 00:16:31.680 --> 00:16:39.150 Gary: just discussed the veggie united syndrome with this patient and not, for example in the other. 80 00:16:40.650 --> 00:16:51.990 Gary: process that may have Kevin fact been present there's inefficient clinic workflow because the staff needs to contact the patient by phone, which is, as you all know, it's often difficult. 81 00:16:52.560 --> 00:16:55.650 Gary: And schedule return appointment for the correct treatment. 82 00:16:56.250 --> 00:17:12.240 Gary: And then there's reduced patient satisfaction and reduced clinicians satisfaction as well, since clinicians feel uncomfortable when they prescribe therapy solely based on an empirical notion of what might be wrong, rather than what is actually wrong next slide please. 83 00:17:16.260 --> 00:17:26.490 Gary: What are the rates of over and under treatment for chlamydia and the ganache Caucus and I think you'll find that the data presented here from six studies. 84 00:17:27.780 --> 00:17:29.730 Gary: is actually quite stunning. 85 00:17:30.960 --> 00:17:34.860 Gary: And, and I want you to focus on the column where. 86 00:17:36.660 --> 00:17:46.530 Gary: Which is a third from the left and second from the Left, where in the third from the Left column it's imperial treatment for a committee in the garden Caucus. 87 00:17:47.160 --> 00:18:03.960 Gary: Where eventually the laboratory results are negative for those two pathogens, this is the percent of patients over treated in these clinical settings and the clinical settings reported here our emergency room departments in. 88 00:18:05.100 --> 00:18:14.280 Gary: inner city hospitals in in most cases, an urgent care Center and baton rouge Louisiana and and so on, these are. 89 00:18:15.120 --> 00:18:24.600 Gary: different regions of the United States different patient populations, but nonetheless the percent of overtreatment and undertreatment are significant in all cases. 90 00:18:25.350 --> 00:18:38.610 Gary: So they range overtreatment ranges from a low of 16% to a high of 86% can you believe it at least as high as 86 or 87% of patients, presenting to. 91 00:18:39.240 --> 00:18:51.960 Gary: One urgent care Center or an emergency room we're actually overtreated on the assumption that they had an STD in this case committee of the Caucus which, in fact, they did not have based on a. 92 00:18:53.310 --> 00:19:05.130 Gary: Quality tests that was performed but was delayed in its results let's look at 2% of patients undertreated in these cases the patients really did have chlamydia are they kind of Caucus. 93 00:19:05.550 --> 00:19:21.810 Gary: But they were not treated at the time they were seeing in the emergency room or urgent care Center well the the undertreatment rate range from a low of 4%, but if you really look through these studies, the highest 86%. 94 00:19:22.980 --> 00:19:33.660 Gary: There were two institutions where the undertreatment rate for commedia and for the Ghana Caucus was 43% and 43% in yet another case. 95 00:19:34.440 --> 00:19:52.950 Gary: So I think, in summary, you can see when you're using Pyrrhic notions of what might be wrong prescribed therapy or declined to prescribe therapy you get and can expect exceedingly high percent of overtreatment and undertreatment next slide please. 96 00:19:55.020 --> 00:20:02.430 Gary: let's look at a another consequence of delayed a diagnosis, which is the patient who's lost the follow up next slide please. 97 00:20:04.320 --> 00:20:15.240 Gary: So, once again we return to Mrs Smith and to a third kind of treatment decision in this case the condition elected not to treat. 98 00:20:15.990 --> 00:20:24.660 Gary: Due to the absence of compelling symptoms or physical exam sites 72 hours later, the central lab recorded detection of the Caucus. 99 00:20:25.200 --> 00:20:37.650 Gary: But then, despite multiple calls by clinic staff and by a county public health worker the patient, could not be contacted, this is an example of a patient who's lost the care next slide please. 100 00:20:39.330 --> 00:20:53.340 Gary: What are the consequences of an STD positive patient who has lost the care in many respects it's rather similar to the consequences of an STD positive patient who has experienced delayed care. 101 00:20:53.790 --> 00:21:06.120 Gary: That is onward transmission of an STD pathogen delayed treatment resolving and complications leading in the case of the kind of conflicts and committee or potentially to pelvic inflammatory disease. 102 00:21:07.080 --> 00:21:16.710 Gary: no opportunity to proceed with an expedited partner treatment, no opportunity for a result enabled face to face condition patient dialogue. 103 00:21:17.430 --> 00:21:26.580 Gary: inefficient clinic workflow because of fruitless attempts by clinic staff to contact the patient by phone to schedule a return appointment for treatment. 104 00:21:27.270 --> 00:21:41.340 Gary: And of course healthcare provider discontent stress and apprehension that the patient remains untreated and may develop complications of their infection next slide please. 105 00:21:42.660 --> 00:21:50.010 Gary: What are the rates of patients last for follow up and i'm just going to summarize. 106 00:21:51.780 --> 00:22:07.530 Gary: The rates for patients last the follow up into settings one is the emergency departments so in one study 40% of adolescent females presenting to the emergency department in grand rapids Michigan were lost to follow up in a. 107 00:22:08.610 --> 00:22:26.970 Gary: In a second study 40% of young women were lost care after the initial emergency room visit in Cincinnati Ohio and yet a third study 8% of patients positive for committee at work on a Caucus were last care in an urban emergency room setting in Philadelphia. 108 00:22:28.230 --> 00:22:35.880 Gary: Turning to a different setting this is the patients last for follow up in STD or family planning clinics. 109 00:22:37.110 --> 00:22:41.490 Gary: So, in a first study 26% of patients tested in an STD. 110 00:22:42.630 --> 00:22:55.170 Gary: clinic in Virginia were lost to follow up in a second study 18% of patients, presenting to an STD clinic in Washington DC were lost the follow up next slide please. 111 00:22:58.950 --> 00:23:10.260 Gary: So we've considered overtreatment rates undertreatment liberates and patients last follow up all of which flow in a significant way from delayed. 112 00:23:12.900 --> 00:23:17.340 Gary: Testing that is patients who are tested, but then. 113 00:23:18.570 --> 00:23:28.380 Gary: Where the test result does not come back for several days and therefore these consequences ensue next slide please. 114 00:23:30.180 --> 00:23:39.570 Gary: So we're going to consider the benefits now a rapid accurate STD point of care diagnostics and how they can transform patient care. 115 00:23:40.350 --> 00:23:45.690 Gary: And, as a consequence, reduce overtreatment rates undertreatment rates and patients last a follow up. 116 00:23:46.410 --> 00:24:00.000 Gary: And by point of care diagnostics that are rapid and accurate here's what I mean, first of all by rapid I mean they return the result during the initial clinic visit and within 30 minutes of receiving the sample. 117 00:24:01.080 --> 00:24:14.310 Gary: So what do I mean by accurate, I mean that they are PCR level accurate and their accuracy is equal to that achieved by large central lab PCR instruments. 118 00:24:14.790 --> 00:24:29.070 Gary: By point of care what I mean is that these tests, take place in a near patient setting in the clinic where the patient is seen, potentially, even in the examining room where the patient is see next slide please. 119 00:24:31.710 --> 00:24:41.520 Gary: So let's compare what it means to have a central lab testing which you're already familiar with this is in the upper panel shown an orange and. 120 00:24:42.540 --> 00:25:02.460 Gary: But then consider the difference in the lower panel in appointed care setting where the results are indicated in green so Mrs Smith vegetable swap would be collected on day one in appointed care setting using a rapid and accurate point of care device. 121 00:25:04.410 --> 00:25:15.060 Gary: A result would have been generated 2828 minutes after the patient presented to that clinic in this case would have shown that the patient was positive for the blackhawks. 122 00:25:16.350 --> 00:25:20.880 Gary: 35 minutes after the patient presented to the clinic on day one. 123 00:25:21.900 --> 00:25:32.460 Gary: On the clinician would be aware of the result and would be engaged in an effective clinician patient dialogue discussing the result. 124 00:25:33.360 --> 00:25:48.990 Gary: Discussing hell STDs are transmitted the complications that may ensue potential changes in sexual behavior that would reduce the risk for STDs and what kind of patient would what kind of therapy would be administered. 125 00:25:50.400 --> 00:25:56.700 Gary: 42 minutes after presentation on day one that patient would have received into muscular safe trachsel. 126 00:25:58.020 --> 00:26:06.930 Gary: For the gun cockle result that was received just a few minutes before and expedited partner therapy would have been initiated. 127 00:26:07.980 --> 00:26:15.150 Gary: All one day one, all within 45 minutes of that patient walking into clinic next slide please. 128 00:26:17.250 --> 00:26:21.390 Gary: So let's consider a scenario now again, Mrs Smith. 129 00:26:22.620 --> 00:26:28.080 Gary: But in the setting of a rapid accurate point of care diagnostic diagnostic. 130 00:26:29.640 --> 00:26:38.520 Gary: So here the treatment decision, the clinician follow the CDC treatment guidelines seth trey aksum was administered as. 131 00:26:39.480 --> 00:26:45.660 Gary: instructed by those guidelines, the patient was tweeted 42 minutes after they entered the clinic. 132 00:26:46.560 --> 00:27:02.340 Gary: correct and proper treatment was enabled by this point of care test, there was no last the follow up there was a specific condition patient educational dialogue and there was expedited partment treatment that was initiated next slide please. 133 00:27:04.950 --> 00:27:10.350 Gary: What are the advantages of a rapid accurate STD point of care test. 134 00:27:11.430 --> 00:27:18.300 Gary: And that can prevent over treatment undertreatment delayed treatment and reduce patient follow up. 135 00:27:19.110 --> 00:27:27.690 Gary: Well, the first advantage is that it enables results driven effective treatment within the span of a single clinic visit second. 136 00:27:28.200 --> 00:27:35.190 Gary: It reduces the probability that an untreated infection with a gun a Caucus committee will progress into the fallopian tubes. 137 00:27:36.090 --> 00:27:46.050 Gary: A third it reduces the probability of ongoing transmission of the pathogen fourth it enables the prompt treatment of the diagnosis. 138 00:27:46.650 --> 00:28:05.730 Gary: diagnosis person's sexual partner via the CDC sanction expedited partner treatment program next it enables what I call the teachable moment where the clinician and the patient can discuss the meaning of that diagnosis diagnosis how its treated and how to avoid. 139 00:28:06.780 --> 00:28:25.950 Gary: Future sexually transmitted diseases next it clearly increases as you'll see in a few moments patient satisfaction by providing the patient with an accurate diagnosis and effective treatment, it increases physician satisfaction by providing the clinician with an accurate diagnosis. 140 00:28:27.060 --> 00:28:43.020 Gary: And it expedites is the test and treat paradigm, it improves clinic workflow it increases the efficiency of clinic staff and likely pause positively affects the clinics cost effectiveness next slide please. 141 00:28:45.030 --> 00:28:55.830 Gary: So I wanted to tell you about one such rapid accurate point of care device and direct you to a publication in The Lancet infectious diseases. 142 00:28:56.430 --> 00:29:16.590 Gary: That looks at a clinical trial that enrolled approximately 2000 patients and which led to the FDA approval of this device for clear wave settings point of care, as well as for large laboratories, should they choose to use it in that setting as well. 143 00:29:17.820 --> 00:29:26.670 Gary: The summary of this study was the time when detection and treatment are important for the control of committees got a Caucus and trichomonas. 144 00:29:27.120 --> 00:29:37.800 Gary: Those are the three organisms that were detected on this point of care PCR device so three three organisms committee of kind of Caucus trichomonas. 145 00:29:38.610 --> 00:29:54.600 Gary: And the objective of this study was to measure the performance of this device is produced by visit this be medical the performance of the visit be medical sexual health test as a single use point of care instrument free PCR device. 146 00:29:56.340 --> 00:30:12.090 Gary: It was led by sheldon moore's Jeffrey klausner who many of you know, was the senior author, the other authors on this study, none of whom are visibly employees participated as P eyes in this clinical trial next slide please. 147 00:30:14.370 --> 00:30:20.370 Gary: The clinical performance of this this be medical point of care device for the three pathogenicity text. 148 00:30:20.850 --> 00:30:31.740 Gary: In terms of positive percent agreement ppa and negative percent agreement MPA are shown here as compared to three large. 149 00:30:32.460 --> 00:30:47.790 Gary: FDA approved laboratory instruments in central labs that use nucleic acid amplification techniques, so you can see that the ppa and the NPA are excellent basically 98% to 99%. 150 00:30:48.540 --> 00:31:02.460 Gary: Essentially, equivalent to the performance from large laboratory instrument, and yet this device is instrument free single use point of care and delivered so resolved in 28 minutes next slide please. 151 00:31:05.280 --> 00:31:19.800 Gary: This device was also used to study, its impact on overtreatment rates undertreatment rates and I wanted to briefly review that study, which is now impress in the journal sexually transmitted diseases. 152 00:31:21.270 --> 00:31:32.010 Gary: This is entitled clinical integration of a highly accurate PCR point of care tests can inform immediate treatment decisions for commedia gonorrhea and trichomonas next slide please. 153 00:31:34.680 --> 00:31:55.800 Gary: The outcomes of this study, where came from an urgent care Center to see how this device effects times treatment accuracy of treatment clinician satisfaction patient satisfaction and how to act how this point of care device can be implemented in a clinic setting next slide please. 154 00:31:57.270 --> 00:32:14.460 Gary: i'm just going to summarize the results, because this is now impressing sexually transmitted diseases into December edition you all can go to it and read it, the results for yourself but in terms of the survey of clinicians satisfaction. 155 00:32:15.840 --> 00:32:22.800 Gary: The clinicians agreed that the test and treat model enabled by this device provides value specifically. 156 00:32:23.670 --> 00:32:29.820 Gary: To the question I would prefer test results right away versus waiting for several days strongly agree. 157 00:32:30.540 --> 00:32:46.980 Gary: By the clinicians who participated, I am an advocate of antibiotic stewardship which this device enables strongly agree, I would find value in discussing those results of the tests right away with my patients strongly agree next slide please. 158 00:32:49.020 --> 00:33:02.580 Gary: here's the patient survey there is value the patients can put it, there is value in same day testing to the question I would prefer to find out results right away versus waiting for several days strongly agree. 159 00:33:04.440 --> 00:33:18.900 Gary: To the result if I needed treatment, I would prefer to get it the same day as my visit strongly agree and to the question I would prefer not to take medication if I don't need to strongly strongly agree next slide please. 160 00:33:20.340 --> 00:33:22.710 Gary: To the questions that looked at. 161 00:33:23.910 --> 00:33:32.940 Gary: The ease of use of a self collected vaginal swab the conclusion by the patient's was self collected agile swabs are easy to use. 162 00:33:33.330 --> 00:33:43.890 Gary: To the question the virtual specimen collection kit was eaters us Greece strongly agree to the question I felt confident using the vegetable specimen collection kit strongly agree. 163 00:33:44.370 --> 00:33:59.160 Gary: To the question I would need supportive a clinician nurse, to be able to use the vegetable specimen collection can disagree, meaning they feel they could do it independently, without direct supervision by a health care provider next slide please. 164 00:34:02.610 --> 00:34:21.870 Gary: i'll just briefly summarize that the overtreatment undertreatment rates, based on the central laboratory instrument, where the same for the chlamydia gonorrhea Caucus and trichomonas as shown in the earlier summary, namely 82% of patients were either were overtreated for commedia. 165 00:34:22.920 --> 00:34:33.720 Gary: 91% over treated for the gun a Caucus when they relied on a delayed central lab result in nearly 90% of trichomonas patients were over tweeted as well. 166 00:34:34.200 --> 00:34:56.400 Gary: The undertreatment rates are shown here as well, in summary in treatment with based instead on the immediate result provided by the vsp device 33 of 33 cases of overtreatment could have been prevented and 13 and 15 cases of undertreatment could have been prevented next slide please. 167 00:34:58.710 --> 00:35:06.840 Gary: What about rapid point of care tests and how to optimize their use in clinic workflow next slide please. 168 00:35:08.400 --> 00:35:22.440 Gary: So this is just a suggestion for how to integrate a rapid point of care test, such as the visit be medical device into a patient workflow in a typical, for example, STD clinic. 169 00:35:23.520 --> 00:35:28.350 Gary: The patient walks in the patient, the patient's chief complaint is identified. 170 00:35:29.070 --> 00:35:39.480 Gary: And if the patient's chief complaint includes, for example, lower abdominal tenderness of pain increased vaginal discharge abnormal vegetable a bleeding a risky risky sexual partner. 171 00:35:40.200 --> 00:36:05.610 Gary: a partner who has an STD STI painful urination increased frequency or bleeding after intercourse than a soft collected vegetables blog is obtained usually in a laboratory in the triage area and we have found that patients can do this with confidence and do it quite easily and accurately. 172 00:36:06.900 --> 00:36:24.030 Gary: Then that swab sample is immediately up inserted into the bespeak medical device the device is run and during the 28 minutes run the patient, then I have some more thorough history taken and the patient is examined. 173 00:36:25.200 --> 00:36:49.560 Gary: Usually, a pelvic exam and then on 28 minutes later, the result of the vsp medical device becomes available and and specific intervention that's result driven then occurs, together with effective patient and education so that treatment and occurs on the same clinic visit next slide please. 174 00:36:52.950 --> 00:37:03.090 Gary: So I want to summarize the main points that i've made today first nucleic acid amplification point of care test has been developed in FDA approved. 175 00:37:03.810 --> 00:37:08.490 Gary: That detects three important STD pathogens, the gun a Caucus committee and trichomonas. 176 00:37:09.120 --> 00:37:17.160 Gary: Clinical trials have demonstrated that this devices as accurate as large laboratory instruments in centralized labs. 177 00:37:17.910 --> 00:37:29.730 Gary: Next, this FDA approved STD point of care tests can provide a result in less than 30 minutes and does enables a patient to be accurately diagnose and correctly treated. 178 00:37:30.330 --> 00:37:38.970 Gary: Within the span of a single clinic visit in addition is easy to use by non technical staff requires less than one minute of hands on time. 179 00:37:39.510 --> 00:37:45.720 Gary: and the results are easily interpreted its use will reduce the likelihood that a patient will be overtreated. 180 00:37:46.380 --> 00:38:01.080 Gary: undertreated experienced delayed treatment or be lost, following this point of care tests can be easily deployed to a variety of clinic settings including urgent care clinics er student student health centers STD clinics. 181 00:38:02.430 --> 00:38:07.050 Gary: And even mobile vans and, eventually, it could even be used at home. 182 00:38:08.310 --> 00:38:17.100 Gary: By providing an accurate result during the span of a single clinic visits, its use will increase patient and clinics and condition satisfaction. 183 00:38:17.730 --> 00:38:26.640 Gary: enable the teachable moment between clinician and patient increased clinical efficiency and improve clinic cost effectiveness. 184 00:38:27.510 --> 00:38:37.410 Gary: Future STD point of care tests will not only detect a pathogen but also simultaneously identify effective antibiotics for that pathogen. 185 00:38:38.010 --> 00:38:47.970 Gary: Does ushering in the era of personalized medicine for infectious diseases and finally use of these devices will play an important role in the control of other. 186 00:38:48.690 --> 00:39:00.270 Gary: Of what I call the other epidemic, which is the ongoing epidemic of St STDs which, despite the current epidemic of coven. 187 00:39:00.750 --> 00:39:14.160 Gary: We know the STD epidemic is a public health crisis, the places risk the health of all, thank you very, very much for your attention to this lecture and I certainly invite your questions. 188 00:39:18.150 --> 00:39:28.680 Jennifer Mahn: Thank you so much for that so good afternoon everyone I do encourage you to continue asking your questions in the Q amp a box, I saw some in the chat make sure you get those in the Q amp a box will be sure to answer them. 189 00:39:29.340 --> 00:39:36.720 Jennifer Mahn: At the end of the webinar today but good afternoon, my name is Jenny Amman i'm from mcs D and I will present today on health department perspectives. 190 00:39:37.080 --> 00:39:49.320 Jennifer Mahn: On point of care, testing, I will be summarizing some work out of an Apollo shop at Johns Hopkins University in baltimore some research that was conducted earlier this year next slide please. 191 00:39:51.390 --> 00:39:57.540 Jennifer Mahn: So what do we already know about point of point of care testing in health departments, well, we know that they're expensive. 192 00:39:58.260 --> 00:40:02.100 Jennifer Mahn: We know that you know the rapid results ease of use and not invasiveness. 193 00:40:02.400 --> 00:40:09.690 Jennifer Mahn: As well as high validity and reliability, are key considerations for us, so if we can make if we can really derive some value out of them. 194 00:40:09.900 --> 00:40:16.230 Jennifer Mahn: And we can fit them in into a busy sexual health clinic, we know that there are very high value as long as we can trust the results. 195 00:40:17.040 --> 00:40:26.970 Jennifer Mahn: But there was a significant gap and there continues to be an understanding of the perspectives of key stakeholders in the decision making processes so running the adoption of point of care tests. 196 00:40:27.510 --> 00:40:41.700 Jennifer Mahn: So, Dr Andrew Apollo decided to conduct some some focus groups around the country with health department staff, including providers administrators nurses, etc, to really understand some broader themes. 197 00:40:42.090 --> 00:40:48.990 Jennifer Mahn: In terms of considerations for point of care STI testing and sexual health clinics and public health settings next slide please. 198 00:40:51.210 --> 00:40:58.290 Jennifer Mahn: So, in early 2021 we assisted in recruiting 27 participants for in depth interviews we conducted to focus group sessions. 199 00:40:58.500 --> 00:41:06.210 Jennifer Mahn: With medical and allied health professionals and their experiences with point of care, testing, and this is specifically for point of care STI testing, do you want to make that very clear. 200 00:41:06.750 --> 00:41:17.070 Jennifer Mahn: Eligibility was defined as individuals with any experience using or prescribing point of care tests in a clinical or field setting for the purposes of diagnostic diagnosing excuse me an STI. 201 00:41:18.150 --> 00:41:21.450 Jennifer Mahn: participants were approached electronically for voluntary participation. 202 00:41:22.350 --> 00:41:30.750 Jennifer Mahn: And the study and snowball sampling was used to identify additional respondents there is a chat that I go slower, so I do apologize for that noted. 203 00:41:31.590 --> 00:41:49.860 Jennifer Mahn: Participants which represented diversity of geography, including the eastern, central southern and Western areas of the US to ensure representativeness also we included clinic and procurement directors nursing supervisors, as stated in STI program managers next slide please. 204 00:41:51.570 --> 00:42:00.900 Jennifer Mahn: So some emerging themes that came up out of this research were you know sort of the types of tests that are available, you know how home testing and how it really came. 205 00:42:01.560 --> 00:42:22.980 Jennifer Mahn: to light in response to the covert 19 pandemic, I think the field really rapidly innovated around home collect self collect testing point of care testing opinions and how people felt about it relationships insurance funding outreach services HIV care and Kovac 19 next slide please. 206 00:42:25.290 --> 00:42:33.990 Jennifer Mahn: So some pros for clients that emerged from the focus groups, including clients feeling empowered by the immediate knowledge of their diagnoses and feeling. 207 00:42:34.830 --> 00:42:44.460 Jennifer Mahn: sort of really knowing for sure, and being able to see the results and they thought that it was a really empowering thing it was used as an entry point for conversations. 208 00:42:45.000 --> 00:42:47.580 Jennifer Mahn: About constantly, for example, about test results. 209 00:42:48.180 --> 00:42:51.810 Jennifer Mahn: Some of the quotes here point of care tests, I think it's so empowering for patients. 210 00:42:52.050 --> 00:43:00.150 Jennifer Mahn: it's empowering because they know what diagnoses, they have so they can be more secure in the treatment that they're getting because their provider has diagnostic certainty. 211 00:43:00.630 --> 00:43:04.530 Jennifer Mahn: Another one here, offering an option or several options to a client. 212 00:43:04.830 --> 00:43:17.730 Jennifer Mahn: is good customer service and it creates opportunity to test based on that client's needs so again four minutes relationship of trust between the provider in the client in the sexual health clinic setting next slide please. 213 00:43:19.830 --> 00:43:33.000 Jennifer Mahn: pros for providers so participants discuss the difficulty with retaining vulnerable populations within their systems for regular follow up, including people experiencing homelessness sex workers and injection drug users. 214 00:43:33.330 --> 00:43:43.080 Jennifer Mahn: Additionally, testing that required lead processing time beyond the visit preclude any immediate diagnosis and treatment, so people worried about loss to follow up transportation concerns, etc. 215 00:43:43.740 --> 00:43:53.400 Jennifer Mahn: Testing capable of producing a result with the patient on site is seen as invaluable for ensuring accurate and timely treatment initiation next slide please. 216 00:43:55.440 --> 00:44:00.120 Jennifer Mahn: So some concept came up for providers and clients when it came to point of care testing is. 217 00:44:00.540 --> 00:44:10.530 Jennifer Mahn: test that produce binary results so qualitative test were widely seen as not being able to provide the necessary granularity for an accurate diagnosis and they were considered inferior. 218 00:44:11.160 --> 00:44:17.430 Jennifer Mahn: To test, you know, in terms of quantitative tests right so PCR is gold standard, we think that that's exceptional. 219 00:44:17.730 --> 00:44:24.030 Jennifer Mahn: But there were some challenges with you know Okay, I get this test we can maybe trust adults, maybe not but then we have to do confirmatory testing. 220 00:44:24.270 --> 00:44:28.350 Jennifer Mahn: So it's really a waste of everyone's resources right and so that's some of the information that came up. 221 00:44:29.130 --> 00:44:37.860 Jennifer Mahn: Again participants noted that certain point of care test required the second gold standard confirmatory test which was difficult Labor intensive and resource intensive. 222 00:44:38.550 --> 00:44:52.830 Jennifer Mahn: Also, poor sensitivity and specificity, as well as test readability were noted, as primary reasons, a patient would have to go in for an undesirable second reading, having to get someone to come back in if they're even able to do so next slide please. 223 00:44:55.230 --> 00:45:06.810 Jennifer Mahn: So something that came up that was really interesting is funding challenges right, so we heard from health departments about the complexities surrounding you know managing the various funding streams that they have to manage. 224 00:45:07.530 --> 00:45:16.650 Jennifer Mahn: In particular, usually providers are not the same individuals tasked with making financial decisions about the programs and managing the financial component. 225 00:45:17.100 --> 00:45:27.390 Jennifer Mahn: And so it's really challenging to kind of piece, all of these different parts together so clients who are the recipients of either state federal or private funding, which often mandated the nature. 226 00:45:28.020 --> 00:45:34.440 Jennifer Mahn: and use the funding for types of point of care test offer like can we even offer this is this, you know allowable under our funding. 227 00:45:35.070 --> 00:45:44.460 Jennifer Mahn: The management of these sources of funding and the various donor requirements was seen as having significant influence on the provision of these services and the adoption of any point of care test. 228 00:45:44.970 --> 00:45:52.800 Jennifer Mahn: And a specific parameters for use for these funding sources, including participation in the approval processes which again can create difficulties for clinics. 229 00:45:53.040 --> 00:46:01.470 Jennifer Mahn: As the attempt to secure additional funding for the services that they already provide in the priority population needs next slide please. 230 00:46:03.570 --> 00:46:13.470 Jennifer Mahn: So many participants noted that their clinics couldn't offer all the tests, they wanted to because of funding limitations right, and so you really have to prioritize who was our population. 231 00:46:13.800 --> 00:46:26.490 Jennifer Mahn: You know how do we serve as many people as we can, what does this look like you kind of have to weigh convenience and you know the patient experience versus financially what you are working with essentially. 232 00:46:27.150 --> 00:46:36.690 Jennifer Mahn: A majority of participants shared the feeling of being constrained by funders and some clinics had to apply a great deal of pressure to funding sources to obtain the test that they needed just to do. 233 00:46:36.960 --> 00:46:39.990 Jennifer Mahn: Every day, just to conduct their services and here's a quote, that really. 234 00:46:40.410 --> 00:46:54.330 Jennifer Mahn: exemplifies that in our HIV STD high risk clinic we have all of these materials, but in our pediatric clinic we had to like beg borrow and steal to get net rapid testing for STD care so there's a lot of sort of in. 235 00:46:55.440 --> 00:47:05.730 Jennifer Mahn: internal challenges and complexities surrounding funding that really influence clinics decisions to engage in point of care testing next slide please. 236 00:47:07.860 --> 00:47:19.110 Jennifer Mahn: So additional funding so test features that just turn around time complexity and cost, as well as operational considerations, including who performs the test were strong barriers to use. 237 00:47:19.410 --> 00:47:25.530 Jennifer Mahn: Also, the different roles of point of care testing from the embodied perspective of the patient clinic and administrator. 238 00:47:25.830 --> 00:47:36.660 Jennifer Mahn: constitute a confluence of considerations that may substantially influenced their use so it's really trying to piece together the larger picture and what we're finding is the larger picture is different, based on sort of. 239 00:47:37.170 --> 00:47:47.340 Jennifer Mahn: Very specific considerations of particular health department clinics and health departments additionally clinics were reluctant to offer new point of care tests if sustainable it sustainably. 240 00:47:48.180 --> 00:47:56.370 Jennifer Mahn: impacted their clinic routines were cost effective and required to clean a license so clear wave tests were much more attractive. 241 00:47:56.790 --> 00:48:09.960 Jennifer Mahn: To our participants, as well as test that were cost effective and that fit well into their workflows if they were able to identify a way where it fits sort of efficiently into their workflow they were more likely to consider it. 242 00:48:10.710 --> 00:48:22.020 Jennifer Mahn: Additionally, it was uncommon for any one of these pieces to be considered in isolation, so again it's this notion of this larger mosaic this big picture of considerations cost. 243 00:48:22.620 --> 00:48:37.290 Jennifer Mahn: workflow efficiency would have all these pieces look like desires of the patients and the patient population and their needs, there wasn't heterogeneity in the precise combination of factors that clinics and programs had to contend with this one next slide. 244 00:48:41.460 --> 00:48:49.950 Jennifer Mahn: Challenges around reimbursement, they were not discussed extensively by our study participants, but we know in previous research that is a consideration in terms of. 245 00:48:51.000 --> 00:49:00.180 Jennifer Mahn: Reimbursement from insurance, for example, most of our participants express that their clinics do what they can to keep costs low for patients, including the cost of testing. 246 00:49:00.630 --> 00:49:07.680 Jennifer Mahn: And while utilizing multiple streams of funding can allow clinics, to provide services that are needed by their target population at low cost. 247 00:49:07.950 --> 00:49:16.080 Jennifer Mahn: Managing multiple funding sources once again is incredibly complex and many clinicians avoid involvement in the funding process because of this. 248 00:49:16.860 --> 00:49:27.330 Jennifer Mahn: And so, as such, there's a distinct gap between those that utilize point of care tasks and those that manage the funding, and so I think this really has to be a collaborative discussion among. 249 00:49:27.750 --> 00:49:36.570 Jennifer Mahn: The administrators and the providers of a clinic and really assessing what does this look like, for us, you know and have people kind of understand each other's perspectives in this. 250 00:49:37.680 --> 00:49:38.190 Jennifer Mahn: Next. 251 00:49:41.220 --> 00:49:47.520 Jennifer Mahn: So the lack of the patient perspective was a strong limitation in this study it's certainly an opportunity for future directions. 252 00:49:48.420 --> 00:49:55.350 Jennifer Mahn: For some clinics that pandemic was a means to reenergize existing plans to provide services, which involves expedited dialogue with funders. 253 00:49:56.040 --> 00:50:08.460 Jennifer Mahn: So, creating these conversations, it was really helpful managing multiple sources of funding, as we know, is a constant challenge for clinics and reimbursement for testing was not an issue discussed by many working in publicly funded clinics. 254 00:50:09.510 --> 00:50:21.810 Jennifer Mahn: And it is imperative that developers and regulators work with client in clinician and users to streamline steps toward adoption of point of care tests for faster and more efficient diagnosis of treatment of St eyes. 255 00:50:22.290 --> 00:50:26.820 Jennifer Mahn: So i'm going to now hand it over to my colleagues at NASA dad Krupa and Angela. 256 00:50:32.970 --> 00:50:40.830 Krupa Mehta, NASTAD (she/her): Thank you so much to all our presenters we have a lot of great questions, we will try to get to as many as we can. 257 00:50:42.540 --> 00:50:47.490 Krupa Mehta, NASTAD (she/her): i'm going to throw this first question out and whoever would like to respond feel free. 258 00:50:48.570 --> 00:50:53.730 Krupa Mehta, NASTAD (she/her): Patients are often treated empirically for chlamydia and gonorrhea while waiting for lab results. 259 00:50:54.480 --> 00:51:09.660 Krupa Mehta, NASTAD (she/her): Is it common for the patient to be positive for both this may be considered overtreatment for one or the other, or the providers able to de escalate when they receive negative lab results how made this overtreatment affect the patient or anti microbial stewardship. 260 00:51:14.760 --> 00:51:19.320 Gary: Well, this is Gary I, I guess, I could be getting the response. 261 00:51:22.260 --> 00:51:26.070 Gary: To the first, this is very complicated question, thank you for that. 262 00:51:27.810 --> 00:51:32.880 Gary: gun a Caucus chlamydia can occur simultaneously and in some settings it's not at all rare. 263 00:51:34.980 --> 00:51:41.850 Gary: If one empirically treats on the assumption that a person has one or the other, or both. 264 00:51:43.680 --> 00:51:52.410 Gary: it's not possible to de escalate care in the case of the gunner Caucus since that's a single injection and would have been given by the time you found the result. 265 00:51:53.610 --> 00:51:59.040 Gary: If the patient eventually comes back committee negative they may be somewhere in that. 266 00:52:00.180 --> 00:52:04.080 Gary: Seven day course of therapy and they could discontinue at that point. 267 00:52:05.220 --> 00:52:10.110 Gary: Whenever anabolic biotics and prescribe unnecessarily there's a risk of. 268 00:52:11.130 --> 00:52:23.310 Gary: Increasing antimicrobial resistance and therefore imperial treatment for these infections is certainly to be avoided if at all possible, simply on that grounds as well. 269 00:52:24.480 --> 00:52:37.380 Gary: I would say that you can see that a an immediate definitive result at the point of care would avoid the problem that is implied by this question. 270 00:52:52.860 --> 00:53:12.390 Krupa Mehta, NASTAD (she/her): This question has come up a few times are you able to talk about the the cost of point of care tests for health departments services and supplies come to them from the health, the health department lab at no cost and approximately 50% of patients don't pay for their visits. 271 00:53:13.770 --> 00:53:14.130 Right. 272 00:53:17.010 --> 00:53:20.910 Gary: I can only speak with respect to the vsp test and simply say that. 273 00:53:23.460 --> 00:53:28.290 Gary: The cost of the business because is dependent in part on. 274 00:53:29.610 --> 00:53:34.440 Gary: The expected volume of the test use in a particular clinic and the. 275 00:53:35.910 --> 00:53:38.010 Gary: And whether the clinic is willing to. 276 00:53:40.410 --> 00:53:44.550 Gary: To provide a contract for a certain period of time. 277 00:53:46.140 --> 00:53:57.840 Gary: The longer the contract, the less expensive the test, but in a more broader arena we're very aware that cost is an important consideration and to that end. 278 00:53:59.550 --> 00:54:05.070 Gary: We have automated or in the process of automating the manufacturing of this device. 279 00:54:06.090 --> 00:54:18.420 Gary: which will significantly reduce the cost of the device to all clinics, including a publicly founded a funded a municipal and county STD clinics. 280 00:54:20.160 --> 00:54:29.700 Gary: In addition, we're working with the Federal Government to look at mechanisms for reimbursement for the cost of point of care devices. 281 00:54:31.050 --> 00:54:39.420 Gary: To publicly funded clinics and underserved areas as an additional mechanism to further reduce the cost. 282 00:54:40.440 --> 00:54:46.170 Gary: Just speaking personally i'm absolutely committed to bring an effective device to. 283 00:54:47.520 --> 00:55:06.090 Gary: publicly funded STD clinics a serving underserved populations it's something I believe strongly in, and we will work with you to find a way to make it happen, we hope that cost alone would not be a reason for you not to use a device that can transform patient care. 284 00:55:09.060 --> 00:55:25.530 Krupa Mehta, NASTAD (she/her): Thank you and Jamie also mentioned in that attack that ncs D is going to be doing a pilot pretty soon, please do reach out to her, if you have any questions about that or would like more information um The next question is how many tests can be run during the 30 minutes on one machine. 285 00:55:26.700 --> 00:55:44.910 Gary: Okay, I saw that question and, and I should have clarified that there is no machine, so there is no limit to how many you can run at the same time, these are single use devices about the size of a maybe a smaller even than a cell phone and. 286 00:55:46.500 --> 00:55:53.130 Gary: After devices used it's put in a biohazard by again it's either disposed of, or it's. 287 00:55:54.870 --> 00:55:55.980 Gary: It can be recycled. 288 00:55:57.780 --> 00:56:06.270 Gary: So if you have 10 patients all coming at the same time you just run 10 of these you just line them up put a table they're very small and you plug. 289 00:56:08.070 --> 00:56:19.560 Gary: Each one in two like a power strip and you can run them all, simultaneously, there is no limit to how many can be run at the same time we've actually demonstrated this into cove ID. 290 00:56:20.280 --> 00:56:32.100 Gary: version of this device, for example, we screened everybody at the national press club, who came in we've screened people at the US gymnastics Olympic team. 291 00:56:33.660 --> 00:56:38.220 Gary: All at the same time, so i'm sorry I didn't make that clear initially. 292 00:56:42.300 --> 00:56:55.680 Krupa Mehta, NASTAD (she/her): Thank you there's a few questions about reporting curious about reporting of positive results to state and local health departments do any studies, you mentioned or others touch on reporting processes for point of care tests. 293 00:56:55.890 --> 00:57:16.530 Gary: Yes, that's a very important question, I was glad to see that um the current device has a visual readout in that deck for the the laboratory and it's not the laboratory but the clinic that uses device, we need to record that result. 294 00:57:18.000 --> 00:57:18.720 Gary: And then. 295 00:57:19.860 --> 00:57:24.930 Gary: deploy that result to through the usual mechanisms to the. 296 00:57:26.250 --> 00:57:27.720 Gary: state and federal. 297 00:57:30.540 --> 00:57:41.550 Gary: Surveillance officers, as is currently the case in the near future, the result will be digitized and that reporting process will be automatic. 298 00:57:42.810 --> 00:57:46.830 Gary: So that it will not require a hands on efforts by the clinic. 299 00:57:50.730 --> 00:57:51.150 Krupa Mehta, NASTAD (she/her): Thank you. 300 00:57:52.650 --> 00:57:56.160 Krupa Mehta, NASTAD (she/her): Rebecca how much time, do you think we have maybe one or two more questions. 301 00:57:57.090 --> 00:58:06.060 Rebekah Horowitz (she/her): yeah i'd say one or two more i'm going to push back on you Gary because there's a lot of pushback in the Q amp a people would like to know. 302 00:58:06.930 --> 00:58:20.640 Rebekah Horowitz (she/her): The initial device cost recognizing that obviously the cost per test will depend on the number performed, but like an estimated or average range of costs and it's been asked by multiple people i'm gonna. 303 00:58:20.910 --> 00:58:22.140 Rebekah Horowitz (she/her): throw back out there. 304 00:58:23.220 --> 00:58:39.660 Gary: I know that they would like something specific figure but trust me that um, it is a moving target in any figure I would give would be misleading and out of date so i'm going to push back and simply say. 305 00:58:40.890 --> 00:59:01.740 Gary: We will work with you to try to do our level best to make this affordable and I will also say that it will be increasingly affordable in significant ways as we move forward in the manufacturing is automated so i'm sorry but I will not be pin down because it wouldn't be accurate. 306 00:59:08.820 --> 00:59:09.570 Rebekah Horowitz (she/her): Good answer. 307 00:59:12.660 --> 00:59:23.070 Rebekah Horowitz (she/her): Some other questions that are in here Krupa since I was unmuted I just figured i'd grab some um there was a question about the rate of invalid or inconclusive results if you have data on that Gary. 308 00:59:23.820 --> 00:59:30.210 Gary: Yes, the the invalid results currently are running around two to 4%, meaning that. 309 00:59:31.980 --> 00:59:37.230 Gary: two to four test out of 100 would give a. 310 00:59:39.060 --> 00:59:54.960 Gary: what's a clearly invalid, saying that the the test did not run satisfactorily and there's very clear visual results that indicate that there was an invalid result, in which case the result would need to be. 311 00:59:56.910 --> 00:59:57.690 Gary: run again. 312 00:59:58.920 --> 01:00:02.730 Gary: And there's enough sample into buffer to run it again. 313 01:00:04.620 --> 01:00:15.720 Gary: As the automation process takes on and it's no longer manufactured by hand at that invalid rate will probably drop to around one to one and a half percent. 314 01:00:18.750 --> 01:00:35.460 Rebekah Horowitz (she/her): And then one final question that I see in here, this could be to any of the studies that were done, whether or not there was any looking into the use of this test in mobile units or other if any of the studies looked at the use. 315 01:00:35.730 --> 01:00:37.740 Rebekah Horowitz (she/her): Not in a non traditional clinical study. 316 01:00:38.340 --> 01:00:52.560 Gary: We we haven't done that yet, but we are talking about such studies, with a number of investigators, who, who, in fact, or have those mobile vans one of them in. 317 01:00:53.670 --> 01:01:05.220 Gary: The Birmingham Alabama area and the other in Rhode island in the in the Providence area we're very interested in doing that, particularly as it affects underserved populations. 318 01:01:06.600 --> 01:01:07.110 Rebekah Horowitz (she/her): Excellent. 319 01:01:08.370 --> 01:01:23.010 Rebekah Horowitz (she/her): Okay we're at two so that it's going to bring us to the end of our webinar I really appreciate all of our presenters for joining us today, I appreciate my colleague organizations at NASA and and cst and co hosting this. 320 01:01:23.640 --> 01:01:32.580 Rebekah Horowitz (she/her): I think this is just a testament to the fact that we should be doing more of these because we serve our Members well and it's nice to have all of us together in one place. 321 01:01:33.480 --> 01:01:41.370 Rebekah Horowitz (she/her): So I hope that we will continue this effort, and I really appreciate this be coming on to present and talk about their new test and. 322 01:01:41.940 --> 01:01:55.170 Rebekah Horowitz (she/her): We will be this was recorded, so we will be posting the recording and the slides so that folks can refer back and feel free to reach out if you have any other additional questions thanks so much bye.