Lab Matters Winter 2021 | Page 22


Advances in Testing Mark 2020 World AIDS Day by Anne Gaynor , PhD , manager , HIV , Hepatitis , STD and TB Programs

Every year on December 1 , the United States and countries around the world recognize World AIDS Day to bring attention to the HIV epidemic , increase HIV knowledge and awareness and speak out against HIV stigma . In 2020 , the theme for World AIDS Day , “ Ending the HIV / AIDS Epidemic : Resilience and Impact ,” mirrored the five-year US plan for Ending the HIV Epidemic ( EHE ).
New Diagnostic Tools
One of the four pillars of EHE is “ Diagnose ” with the goal of diagnosing all people with HIV as early as possible . As we reflect back on 2020 and continue to move forward in 2021 there are several notable advances to help meet the goals of EHE , including the FDA-approval of eight new HIV assays , with seven approved as an aid in HIV diagnosis :
• First HIV-2 NAT ( cobas ® HIV-1 / HIV-2 Qualitative , Roche Molecular Systems , Inc .)
• First diagnostic test to detect HIV and Syphilis simultaneously ( DPP ® HIV-Syphilis System , Chembio Diagnostic Systems , Inc .)
• First HIV-1 NAT with a “ dual-claim ” that can be used for qualitative diagnosis and viral load monitoring ( Aptima ® HIV-1 Quant Dx , Hologic , Inc .)
• A second supplemental antibody differentiation assay ( VioOne HIV Profile™ Supplemental Assay , Avioq , Inc .)
• Three additional HIV antigen / antibody screening assays ( Elecsys ® HIV Duo , Roche ; Alinity I HIV Ag / Ab Combo , Abbott Laboratories ; LIAISON ® XL MUREX HIV Ab / Ag HT , DiaSorin , Inc .)
• One additional quantitative NAT for viral load monitoring on a new platform ( Alinity m HIV-1 , Abbott Molecular , Inc .)
In addition to all of the newly approved assays , the US Food and Drug Administration ( FDA ) has also proposed re-classification of HIV assays for diagnosis and monitoring from class III to class II with special controls . If this proposed re-classification takes place , which we anticipate , we are hopeful that more innovative assays are able to be more readily developed , evaluated and approved for use in the US .
Making Testing More Accessible
Another aspect of the EHE initiative is to expand testing to meet people where they live . This includes improving availability of testing , addressing concerns about privacy and considerations for less invasive specimen collection methods . The US Centers for Disease Control and Prevention ( CDC ) and several national agencies are pushing for increased rapid testing . However , there are no FDA-approved point-of-care confirmatory tests for HIV testing at this time , so any person with a preliminary positive HIV result should still have blood drawn and sent to a laboratory . There is increasing interest in using alternative specimen types such as dried blood spots ( DBS ) that can be collected by fingerstick and are straightforward to package and mail to a laboratory for testing . However , the specimen type and approach ( collection in a non-clinical setting ) is not without its challenges as it is not an approved specimen type on any laboratory-based FDA-approved HIV diagnostic test and the performance may differ from the FDA-approved test ( i . e ., decreased sensitivity , inability to detect HIV-1 p24 antigen , etc .).
Public health laboratories exploring this option with their health department may be able to offer testing ( screening or confirmatory ) to previously unreachable populations with alternative specimen types and collection methods that would improve acceptability and uptake of testing . We look forward to seeing more growth in this area over time such as FDA-approved methods that include this specimen type . n
20 LAB MATTERS Winter 2021
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