Diagnostic effectiveness of HIV-1 quantitative nucleic acid assay as a supplementary test for individuals with indeterminate or negative western blot antibody test results — China, 2018–2023
Background Based on China’s current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream su...
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| Vydáno v: | BMC infectious diseases Ročník 25; číslo 1; s. 1637 - 8 |
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BioMed Central
21.11.2025
BioMed Central Ltd BMC |
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| Abstract | Background
Based on China’s current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream supplemental assay due to its shorter window period, holding significant importance in detecting acute HIV-1 infection. Currently, over 800 laboratories in China can perform HIV-1 NAT. However, most NAT kits are designed for viral load (VL) detection, typically used to assess treatment efficacy in confirmed patients. This study aimed to explore the diagnostic efficacy of HIV-1 quantitative NAT at varying medical decision points, as well as the methodological preference for antibody screening, to support better implementation of HIV-1 testing and accurate identification of HIV-1 infections in China.
Methods
Testing records of 11,369 samples with WB-indeterminate or -negative results during 2018–2023 were collected from the central HIV confirmatory laboratory databases of 20 provincial CDCs. Methodological preferences in HIV-1 antibody screening, diagnostic performance of single- or double-reactive results in retesting and quantitative NAT at varying diagnostic thresholds were analyzed.
Results
Chemiluminescence immunoassay (CLIA) was the most widely used method for initial screening (42.77%) and the seroconversion rate was significantly higher in cases with double-positive retest results compared to single-positive results (75.95% vs. 27.25% for WB-indeteminate results and 20.31% vs. 7.26% for WB-negative results, respectively). The specificity and positive predictive values of HIV-1 quantitative NAT were 100% at each medical decision points, and the sensitivity and negative predictive value decreased from 99.92% to 99.93% to 94.71% and 95.64%. Two samples with undetectable viral loads were ultimately diagnosed as HIV-1 infections, alerting us to consider individual exposure history when managing antibody screening-reactive but VL-undetectable cases.
Conclusions
Quantitative HIV-1 NAT enables rapid and accurate infection confirmation, earlier identification and timely treatment initiation. |
|---|---|
| AbstractList | Abstract Background Based on China’s current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream supplemental assay due to its shorter window period, holding significant importance in detecting acute HIV-1 infection. Currently, over 800 laboratories in China can perform HIV-1 NAT. However, most NAT kits are designed for viral load (VL) detection, typically used to assess treatment efficacy in confirmed patients. This study aimed to explore the diagnostic efficacy of HIV-1 quantitative NAT at varying medical decision points, as well as the methodological preference for antibody screening, to support better implementation of HIV-1 testing and accurate identification of HIV-1 infections in China. Methods Testing records of 11,369 samples with WB-indeterminate or -negative results during 2018–2023 were collected from the central HIV confirmatory laboratory databases of 20 provincial CDCs. Methodological preferences in HIV-1 antibody screening, diagnostic performance of single- or double-reactive results in retesting and quantitative NAT at varying diagnostic thresholds were analyzed. Results Chemiluminescence immunoassay (CLIA) was the most widely used method for initial screening (42.77%) and the seroconversion rate was significantly higher in cases with double-positive retest results compared to single-positive results (75.95% vs. 27.25% for WB-indeteminate results and 20.31% vs. 7.26% for WB-negative results, respectively). The specificity and positive predictive values of HIV-1 quantitative NAT were 100% at each medical decision points, and the sensitivity and negative predictive value decreased from 99.92% to 99.93% to 94.71% and 95.64%. Two samples with undetectable viral loads were ultimately diagnosed as HIV-1 infections, alerting us to consider individual exposure history when managing antibody screening-reactive but VL-undetectable cases. Conclusions Quantitative HIV-1 NAT enables rapid and accurate infection confirmation, earlier identification and timely treatment initiation. Based on China's current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream supplemental assay due to its shorter window period, holding significant importance in detecting acute HIV-1 infection. Currently, over 800 laboratories in China can perform HIV-1 NAT. However, most NAT kits are designed for viral load (VL) detection, typically used to assess treatment efficacy in confirmed patients. This study aimed to explore the diagnostic efficacy of HIV-1 quantitative NAT at varying medical decision points, as well as the methodological preference for antibody screening, to support better implementation of HIV-1 testing and accurate identification of HIV-1 infections in China.BACKGROUNDBased on China's current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream supplemental assay due to its shorter window period, holding significant importance in detecting acute HIV-1 infection. Currently, over 800 laboratories in China can perform HIV-1 NAT. However, most NAT kits are designed for viral load (VL) detection, typically used to assess treatment efficacy in confirmed patients. This study aimed to explore the diagnostic efficacy of HIV-1 quantitative NAT at varying medical decision points, as well as the methodological preference for antibody screening, to support better implementation of HIV-1 testing and accurate identification of HIV-1 infections in China.Testing records of 11,369 samples with WB-indeterminate or -negative results during 2018-2023 were collected from the central HIV confirmatory laboratory databases of 20 provincial CDCs. Methodological preferences in HIV-1 antibody screening, diagnostic performance of single- or double-reactive results in retesting and quantitative NAT at varying diagnostic thresholds were analyzed.METHODSTesting records of 11,369 samples with WB-indeterminate or -negative results during 2018-2023 were collected from the central HIV confirmatory laboratory databases of 20 provincial CDCs. Methodological preferences in HIV-1 antibody screening, diagnostic performance of single- or double-reactive results in retesting and quantitative NAT at varying diagnostic thresholds were analyzed.Chemiluminescence immunoassay (CLIA) was the most widely used method for initial screening (42.77%) and the seroconversion rate was significantly higher in cases with double-positive retest results compared to single-positive results (75.95% vs. 27.25% for WB-indeteminate results and 20.31% vs. 7.26% for WB-negative results, respectively). The specificity and positive predictive values of HIV-1 quantitative NAT were 100% at each medical decision points, and the sensitivity and negative predictive value decreased from 99.92% to 99.93% to 94.71% and 95.64%. Two samples with undetectable viral loads were ultimately diagnosed as HIV-1 infections, alerting us to consider individual exposure history when managing antibody screening-reactive but VL-undetectable cases.RESULTSChemiluminescence immunoassay (CLIA) was the most widely used method for initial screening (42.77%) and the seroconversion rate was significantly higher in cases with double-positive retest results compared to single-positive results (75.95% vs. 27.25% for WB-indeteminate results and 20.31% vs. 7.26% for WB-negative results, respectively). The specificity and positive predictive values of HIV-1 quantitative NAT were 100% at each medical decision points, and the sensitivity and negative predictive value decreased from 99.92% to 99.93% to 94.71% and 95.64%. Two samples with undetectable viral loads were ultimately diagnosed as HIV-1 infections, alerting us to consider individual exposure history when managing antibody screening-reactive but VL-undetectable cases.Quantitative HIV-1 NAT enables rapid and accurate infection confirmation, earlier identification and timely treatment initiation.CONCLUSIONSQuantitative HIV-1 NAT enables rapid and accurate infection confirmation, earlier identification and timely treatment initiation. Background Based on China’s current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream supplemental assay due to its shorter window period, holding significant importance in detecting acute HIV-1 infection. Currently, over 800 laboratories in China can perform HIV-1 NAT. However, most NAT kits are designed for viral load (VL) detection, typically used to assess treatment efficacy in confirmed patients. This study aimed to explore the diagnostic efficacy of HIV-1 quantitative NAT at varying medical decision points, as well as the methodological preference for antibody screening, to support better implementation of HIV-1 testing and accurate identification of HIV-1 infections in China. Methods Testing records of 11,369 samples with WB-indeterminate or -negative results during 2018–2023 were collected from the central HIV confirmatory laboratory databases of 20 provincial CDCs. Methodological preferences in HIV-1 antibody screening, diagnostic performance of single- or double-reactive results in retesting and quantitative NAT at varying diagnostic thresholds were analyzed. Results Chemiluminescence immunoassay (CLIA) was the most widely used method for initial screening (42.77%) and the seroconversion rate was significantly higher in cases with double-positive retest results compared to single-positive results (75.95% vs. 27.25% for WB-indeteminate results and 20.31% vs. 7.26% for WB-negative results, respectively). The specificity and positive predictive values of HIV-1 quantitative NAT were 100% at each medical decision points, and the sensitivity and negative predictive value decreased from 99.92% to 99.93% to 94.71% and 95.64%. Two samples with undetectable viral loads were ultimately diagnosed as HIV-1 infections, alerting us to consider individual exposure history when managing antibody screening-reactive but VL-undetectable cases. Conclusions Quantitative HIV-1 NAT enables rapid and accurate infection confirmation, earlier identification and timely treatment initiation. Based on China's current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream supplemental assay due to its shorter window period, holding significant importance in detecting acute HIV-1 infection. Currently, over 800 laboratories in China can perform HIV-1 NAT. However, most NAT kits are designed for viral load (VL) detection, typically used to assess treatment efficacy in confirmed patients. This study aimed to explore the diagnostic efficacy of HIV-1 quantitative NAT at varying medical decision points, as well as the methodological preference for antibody screening, to support better implementation of HIV-1 testing and accurate identification of HIV-1 infections in China. Testing records of 11,369 samples with WB-indeterminate or -negative results during 2018-2023 were collected from the central HIV confirmatory laboratory databases of 20 provincial CDCs. Methodological preferences in HIV-1 antibody screening, diagnostic performance of single- or double-reactive results in retesting and quantitative NAT at varying diagnostic thresholds were analyzed. Chemiluminescence immunoassay (CLIA) was the most widely used method for initial screening (42.77%) and the seroconversion rate was significantly higher in cases with double-positive retest results compared to single-positive results (75.95% vs. 27.25% for WB-indeteminate results and 20.31% vs. 7.26% for WB-negative results, respectively). The specificity and positive predictive values of HIV-1 quantitative NAT were 100% at each medical decision points, and the sensitivity and negative predictive value decreased from 99.92% to 99.93% to 94.71% and 95.64%. Two samples with undetectable viral loads were ultimately diagnosed as HIV-1 infections, alerting us to consider individual exposure history when managing antibody screening-reactive but VL-undetectable cases. Quantitative HIV-1 NAT enables rapid and accurate infection confirmation, earlier identification and timely treatment initiation. Background Based on China's current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream supplemental assay due to its shorter window period, holding significant importance in detecting acute HIV-1 infection. Currently, over 800 laboratories in China can perform HIV-1 NAT. However, most NAT kits are designed for viral load (VL) detection, typically used to assess treatment efficacy in confirmed patients. This study aimed to explore the diagnostic efficacy of HIV-1 quantitative NAT at varying medical decision points, as well as the methodological preference for antibody screening, to support better implementation of HIV-1 testing and accurate identification of HIV-1 infections in China. Methods Testing records of 11,369 samples with WB-indeterminate or -negative results during 2018-2023 were collected from the central HIV confirmatory laboratory databases of 20 provincial CDCs. Methodological preferences in HIV-1 antibody screening, diagnostic performance of single- or double-reactive results in retesting and quantitative NAT at varying diagnostic thresholds were analyzed. Results Chemiluminescence immunoassay (CLIA) was the most widely used method for initial screening (42.77%) and the seroconversion rate was significantly higher in cases with double-positive retest results compared to single-positive results (75.95% vs. 27.25% for WB-indeteminate results and 20.31% vs. 7.26% for WB-negative results, respectively). The specificity and positive predictive values of HIV-1 quantitative NAT were 100% at each medical decision points, and the sensitivity and negative predictive value decreased from 99.92% to 99.93% to 94.71% and 95.64%. Two samples with undetectable viral loads were ultimately diagnosed as HIV-1 infections, alerting us to consider individual exposure history when managing antibody screening-reactive but VL-undetectable cases. Conclusions Quantitative HIV-1 NAT enables rapid and accurate infection confirmation, earlier identification and timely treatment initiation. Keywords: HIV-1 viral load testing, Western blot, Nucleic acid testing, HIV testing algorithm, Diagnostic threshold Based on China's current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status confirmed by HIV-1 antibody Western Blot or nucleic acid testing (NAT). In recent years, NAT has gradually become the mainstream supplemental assay due to its shorter window period, holding significant importance in detecting acute HIV-1 infection. Currently, over 800 laboratories in China can perform HIV-1 NAT. However, most NAT kits are designed for viral load (VL) detection, typically used to assess treatment efficacy in confirmed patients. This study aimed to explore the diagnostic efficacy of HIV-1 quantitative NAT at varying medical decision points, as well as the methodological preference for antibody screening, to support better implementation of HIV-1 testing and accurate identification of HIV-1 infections in China. Testing records of 11,369 samples with WB-indeterminate or -negative results during 2018-2023 were collected from the central HIV confirmatory laboratory databases of 20 provincial CDCs. Methodological preferences in HIV-1 antibody screening, diagnostic performance of single- or double-reactive results in retesting and quantitative NAT at varying diagnostic thresholds were analyzed. Chemiluminescence immunoassay (CLIA) was the most widely used method for initial screening (42.77%) and the seroconversion rate was significantly higher in cases with double-positive retest results compared to single-positive results (75.95% vs. 27.25% for WB-indeteminate results and 20.31% vs. 7.26% for WB-negative results, respectively). The specificity and positive predictive values of HIV-1 quantitative NAT were 100% at each medical decision points, and the sensitivity and negative predictive value decreased from 99.92% to 99.93% to 94.71% and 95.64%. Two samples with undetectable viral loads were ultimately diagnosed as HIV-1 infections, alerting us to consider individual exposure history when managing antibody screening-reactive but VL-undetectable cases. Quantitative HIV-1 NAT enables rapid and accurate infection confirmation, earlier identification and timely treatment initiation. |
| ArticleNumber | 1637 |
| Audience | Academic |
| Author | Zhang, Xin Pan, Pinliang Jin, Cong Liu, Pei Wang, Yu Ding, Haifeng Ding, Mengjun Zhu, Qiyu |
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| Cites_doi | 10.13419/j.cnki.aids.2017.01.03 10.16571/j.cnki.1008-8199.2022.02.004 10.1111/trf.12298 10.1016/j.jcv.2021.104911 10.1053/j.semdp.2017.04.008 10.1080/07388551.2020.1751058 10.1128/spectrum.03218-24 10.7326/0003-4819-130-1-199901050-00007 10.15620/cdc.23447 10.13419/j.cnki.aids.2021.01.17 10.3389/fmicb.2019.01322 10.1016/S0140-6736(97)01500-6 10.3967/bes2017.121 10.1186/s12879-024-09486-8 |
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Based on China’s current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with... Based on China's current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with infection status... Background Based on China's current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests, with... Abstract Background Based on China’s current HIV-1 testing algorithm, samples with initial positive antibody screening require two additional repeat tests,... |
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| SubjectTerms | Adult Algorithms Analysis Antibodies Blotting, Western China Diagnostic threshold Female Health aspects HIV Antibodies - blood HIV infection HIV Infections - diagnosis HIV Infections - virology HIV testing HIV testing algorithm HIV-1 - genetics HIV-1 - immunology HIV-1 - isolation & purification HIV-1 viral load testing Humans Infectious Diseases Internal Medicine Male Measurement Medical Microbiology Medicine Medicine & Public Health Middle Aged Nucleic Acid Amplification Techniques - methods Nucleic acid testing Parasitology Prevention Risk factors Sensitivity and Specificity Testing Tropical Medicine Viral antibodies Viral Load Viremia Western blot Young Adult |
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| Title | Diagnostic effectiveness of HIV-1 quantitative nucleic acid assay as a supplementary test for individuals with indeterminate or negative western blot antibody test results — China, 2018–2023 |
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