INFECTIOUS DISEASES
Self-testing and Self-collection : What ’ s Next ?
By Sarah Buss , PhD , D ( ABMM ), manager , HIV , Hepatitis , STI and TB
STI programs and health departments contract with NCSD to participate , and a nursing line is available for follow up and referral . Notification systems trigger alerts ( e . g ., no sample received within a week of sending kit ) and reports are delivered electronically with automated reportable disease notifications sent to health departments . Zamora explained that Check Yourself uses prepaid shipping and temperature monitoring devices to help assure quality preanalytical processes . When asked about specimen return rates , Zamora cited NCSD data that demonstrated that specimen return rates were higher when collection kits were picked up at a clinic (~ 90 %) compared to those picked up in the community or by mail (~ 30 %).
Self-collection and self-testing are not new concepts , as in-home self-monitoring of blood glucose has been the standard of care for patients since the 1980s . Although the OraQuick In-Home HIV Test was US Food and Drug Administration ( FDA ) approved in 2012 , widespread home-based testing for infectious diseases was not commonplace in the United States until COVID-19 upended the world . The pandemic showed that in-home collection and testing models have the potential to increase access to and uptake of testing services , likely because of the convenience , privacy and anonymity afforded to patients .
When self-testing or self-collection programs are properly implemented , the resulting increase in testing could lead to earlier detection , linkage to care and , ultimately , reduced transmission and disease incidence . To address how best to implement and address obstacles in this space , Megan Crumpler , PhD , director of the Orange County Public Health Laboratory and APHL president-elect , moderated a roundtable at APHL 2023 entitled , “ Is Self-testing the Future or Will We Adhere to the Past ?” This roundtable engaged members in discussing the utilization of different approaches and highlighted the benefits and challenges laboratories face as public demand for access to these models surges .
Finding the Best of Both Worlds
Jessica Zamora , MPH , from the National Coalition of STD Directors ( NCSD ), discussed NCSD ’ s Check Yourself initiative , a collaboration with LetsGetChecked . This model pairs selfcollection with laboratory-based testing for several different sexually transmitted infections ( STI ) in home-collected urine and fingerstick whole blood specimens .
A challenge that laboratories may be struggling with is how to ensure that a self-collected approach meets the regulatory requirements that laboratories must follow . At the Florida Bureau of Public Health Laboratories , the method used for CT / GC testing was approved for use on vaginal specimens that were patient-collected in a clinical setting where support and counseling is available to explain procedures and precautions . Susanne Crowe , PhD , MHA , shared that her laboratory was able to complete a verification study prior to being able to offer testing for these specimens . Crowe explained that more self-collection options with valid regulatory claims are needed to further advance selftesting or self-collection initiatives . When self-collection is not covered by a test ’ s regulatory claim , standard CLIA verification and validation studies are not sufficient , and appropriate studies for
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References :
1 . Free , AH , Free , HM . Self testing , an emerging component of clinical chemistry . Clin Chem . 1984 Jun ; 30 ( 6 ): 829-38 . PMID : 6723038 . Available from https :// pubmed . ncbi . nlm . nih . gov / 6723038 /. 2 . Hirsch , IB . Introduction : History of Glucose Monitoring . ADA Clinical Compendia 1 August 2018 ; 2018 ( 1 ): 1 . Available from https :// diabetesjournals . org / compendia / article / 2018 / 1 / 1 / 144616 /
Introduction-History-of-Glucose-Monitoring . 3 . US FDA . OraQuick In-home HIV Test Information . Available from https :// www . fda . gov / vaccines-blood-biologics / approved-blood-products / oraquick-home-hiv-test #:~: text = The % 20
OraQuick % C2 % AE % 20In-Home % 20HIV % 20Test % 20is % 20an % 20in-vitro , testing % 20is % 20needed .% 20Approval % 20Date % 3A % 20July % 203 % 2C % 202012 . 4 . Rubin R . COVID-19 Testing Moves Out of the Clinic and Into the Home . JAMA . 2021 ; 326 ( 14 ): 1362 – 1364 . doi : 10.1001 / jama . 2021.15679 . Available from https :// jamanetwork . com / journals / jama / fullarticle / 2784554 . 5 . Rader B , Gertz A , Iuliano AD , et al . Use of At-Home COVID-19 Tests — United States , August 23 , 2021 – March 12 , 2022 . MMWR Morb Mortal Wkly Rep 2022 ; 71:489 – 494 . Available from DOI : http :// dx . doi . org / 10.15585 / mmwr . mm7113e1 .
28 LAB MATTERS Fall 2023
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