Access HIV Combo V2 검사의 성능 평가 = Performance Evaluation of Access HIV Combo V2 Assay

국문 초록 (Abstract)

배경: 적절한 검사를 통한 HIV-1/2의 정확한 진단은 매우 중요하다. Access HIV Combo V2 (Bio-Rad Laboratories, USA)는 기존의 제4세대 HIV 검사에서 검출하지 못하는 HIV-2 p26 항원도 검출하는 검사로, 본 연구에서는 이의 임상적 유용성을 확인하고자 하였다.
방법: 2021년 9월부터 10월까지 서울대학교병원에서 ARCHITECT HIV Ag/Ab Combo (Abbott Laboratories, USA)로 검사한 총 1,100건의 음성 검체가 포함되었다. 또한, 서울대학교병원에서 ARCHITECT HIV Ag/Ab Combo 검사에서 양성으로 나와 웨스턴 블롯/RNA 분석으로 확진된 혈청 25건과 중앙대학교병원 바이오뱅크 혈청 60건, 그리고 상품화 검체 15건(HIV-1 p24 항원 9건, HIV-2 Ab 3건, HIV-2 p26 항원 양성 3건)이 포함되었다. 혈청 전환 민감도 평가를 위해서는 3개의 혈청 전환 패널을 검사하였다. 정밀도는 세 가지 농도(NC, PC1, PC2)의 QC 시료를 5일 연속으로 하루에 5회씩 검사하였으며 잔효(carry-over)도 평가하였다.
결과: Access HIV Combo V2의 민감도와 특이도는 각각 100.00% (95% CI, 96.4–100.0%), 99.82% (95% CI, 99.3–99.9%)였다. Access HIV Combo V2는 ARCHITECT HIV Ag/Ab Combo 또는 Elecsys HIV Combo PT (Roche Diagnostics, Germany)와 비교하여 유사한 혈청 전환 민감도를 보였다. 검사실내 변이계수(CV)는 NC, PC1, PC2의 경우 각각 9.5%, 3.7%, 3.9%였으며 잔효는 관찰되지 않았다.
결론: Access HIV Combo V2는 우수한 민감도와 특이도를 보였으며 정밀도가 우수하고 잔효가 없었다. 혈청 전환 민감도는 기존 4세대 HIV 검사와 유사하였다.

다국어 초록 (Multilingual Abstract)

Background: The recently introduced 4th generation HIV assay, Access HIV Combo V2 (Bio-Rad Laboratories, USA), can detect the HIV-2 p26 antigen, which has not been targeted by other 4th generation HIV assays. We evaluated the clinical utility of the Access HIV Combo V2 assay.
Methods: A total of 1,100 negative samples evaluated using the ARCHITECT HIV Ag/Ab Combo assay (Abbott Laboratories, USA) in Seoul National University Hospital (SNUH) during September 2021 and October 2021 were included. Additional 100 positive samples, including 25 sera from SNUH that showed positive ARCHITECT HIV Ag/Ab Combo and western blot/RNA assay results, along with 60 sera from Chung-Ang University Hospital Biobank and 15 commercial samples (9 HIV-1 p24 antigen-, 3 HIV-2 antibody-, 3 HIV-2 p26 antigen-positive), were included. Three seroconversion panel samples were tested for seroconversion sensitivity. Three levels (NC, PC1, and PC2) of QC materials were tested for precision 5 times a day for 5 consecutive days, and carry-over was also evaluated.
Results: Sensitivity and specificity of Access HIV Combo V2 were 100.00% (95% CI: 96.38–100.0%) and 99.82% (95% CI: 99.34–99.98%), respectively. Access HIV Combo V2 showed seroconversion sensitivity comparable to that of ARCHITECT HIV Ag/Ab Combo and Elecsys HIV combi PT (Roche Diagnostics, Germany). Within-laboratory CV were 9.5%, 3.7%, and 3.9% for NC, PC1, and PC2, respectively, and no carry-over was observed.
Conclusions: Access HIV Combo V2 assay showed excellent sensitivity and specificity, good precision, and no carry-over. Its seroconversion sensitivity was comparable to that of existing 4th generation HIV assays.

참고문헌 (Reference)

• 1 강희정 ; 유경하 ; 김한성 ; 조현찬, "애보트 4세대 HIV 항원/항체 검사 시약의 평가" 대한진단검사의학회 26 (26): 39-44, 2006
• 2 Peruski AH, "Trends in HIV-2 diagnoses and use of the HIV-1/HIV-2 differentiation test-United States, 2010-2017" 69 : 63-66, 2020
• 3 Eaton JW, "The cost of not retesting : human immunodeficiency virus misdiagnosis in the antiretroviral therapy"Test-and-Offer"era" 65 : 522-525, 2017
• 4 Hurt CB, "Selecting an HIV test : a narrative review for clinicians and researchers" 44 : 739-746, 2017
• 5 Gürtler L, "Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay" 75 : 27-38, 1998
• 6 Krasowski MD, "Real-world clinical performance evaluation of a fourth-generation HIV antigen/antibody differentiation test" 6 : 1417-1432, 2021
• 7 Clinical and Laboratory Standards Institute, "Preliminary evaluation of quantitative clinical laboratory measurement procedures; Approved guideline" Clinical and Laboratory Standards Institute 2006
• 8 Greig JR, "Positive predictive value is poor in low risk populations seen in universal screening for HIV infection" 346 : f3575-, 2013
• 9 Song EY, "Performances of four fourth-generation human immunodeficiency virus-1 screening assays" 84 : 1884-1888, 2012
• 10 Mühlbacher A, "Performance evaluation of a new fourth-generation HIV combination antigen-antibody assay" 202 : 77-86, 2013
• 11 Mitchell EO, "Performance comparison of the 4th generation Bio-Rad Laboratories GS HIV Combo Ag/Ab EIA on the EVOLIS™ automated system versus Abbott ARCHITECT HIV Ag/Ab Combo, Ortho Anti-HIV 1+2 EIA on Vitros ECi and Siemens HIV-1/O/2 enhanced on Advia Centaur" 58 (58): e79-e84, 2013
• 12 Nam JG, "Molecular investigation of human immunodeficiency virus type 2 subtype a cases in South Korea" 44 : 1543-1546, 2006
• 13 Alfie LG, "Increased risk of false-positive HIV ELISA results after COVID-19" 37 : 947-950, 2023
• 14 Gudipati S, "Increase in false positive fourth generation HIV tests in patients with COVID-19 disease" ciad264-, 2023
• 15 Berzow D, "Human immunodeficiency virus-2(HIV-2) : a summary of the present standard of care and treatment options for individuals living with HIV-2 in Western Europe" 72 : 503-509, 2021
• 16 Alexander TS, "Human immunodeficiency virus diagnostic testing : 30 years of evolution" 23 : 249-253, 2016
• 17 Kim S, "False-positive rate of a"fourth-generation"HIV antigen/antibody combination assay in an area of low HIV prevalence" 17 : 1642-1644, 2010
• 18 Matheron S, "Factors associated with clinical progression in HIV-2 infected-patients : the French ANRS cohort" 17 : 2593-2601, 2003
• 19 Vallefuoco L, "Evaluation of the siemens HIV antigen-antibody immunoassay" 57 : 106-111, 2014
• 20 Cui C, "Evaluation of the clinical effectiveness of HIV antigen/antibody screening using a chemiluminescence microparticle immunoassay" 214 : 33-36, 2015
• 21 Clinical and Laboratory Standards Institute, "Evaluation of precision of quantitative measurement procedures; Approved guideline" Clinical and Laboratory Standards Institute 2014
• 22 정보경 ; 김하늬 ; 최지선 ; 신경희 ; 이창규 ; 조윤정, "Elecsys HIV combi PT 검사와 ARCHITECT HIV Ag/Ab Combo 검사의 성능 비교 평가" 대한진단검사의학회 4 (4): 157-163, 2014
• 23 Fiebig EW, "Dynamics of HIV viremia and antibody seroconversion in plasma donors : implications for diagnosis and staging of primary HIV infection" 17 : 1871-1879, 2003
• 24 Adhikari EH, "Diagnostic accuracy of fourth-generation ARCHITECT HIV Ag/Ab Combo assay and utility of signal-to-cutoff ratio to predict false-positive HIV tests in pregnancy" 219 : 408-, 2018
• 25 Dougan S, "Diagnoses of HIV-1 and HIV-2 in England, Wales, and Northern Ireland associated with west Africa" 81 : 338-341, 2005
• 26 World Health Organization, "Consolidated guidelines on HIV prevention, testing, treatment, service delivery and monitoring: recommendations for a public health approach"
• 27 Stone M, "Comparison of detection limits of fourth-and fifth-generation combination HIV Aantigen-antibody, p24 antigen, and viral load assays on diverse HIV isolates" 56 : e02045-17-, 2018
• 28 Korea Disease Control and Prevention Agency, "Annual Report on the Notified HIV/AIDS in Korea 2021"
• 29 Zucker J, "Am I positive? Improving human immunodeficiency virus testing in the era of preexposure prophylaxis and immediate antiretroviral therapy using machine learning" 9 : ofac259-, 2022
• 30 Lu X, "A method to alleviate false-positive results of the Elecsys HIV combi PT assay" 11 : 1033-, 2021
• 31 Korea Disease Control and Prevention Agency, "2023 HIV/AIDS Management Guidelines"