Journal of clinical virology : the official publication of the Pan American Society for Clinical Virology · 2026
Resolving the clinical dilemma of low positive HIV screening: 2-mercaptoethanol as the optimal pretreatment over polyethylene glycol precipitation to safeguard early diagnosis.
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Qin Ling, Zhang Ping, Yan Haifeng, Zhang Huiyan, Gao Ming
Аннотация
BACKGROUND: The high sensitivity of fourth-generation HIV antigen/antibody combo assays leads to a substantial number of low-positive screening results, creating a diagnostic dilemma. Guidelines suggest polyethylene glycol (PEG) 6000 or 2-mercaptoethanol (2-ME) pretreatment to resolve interference, yet their comparative performance on modern platforms remains inadequately validated.
METHODS: We retrospectively analyzed 589 initially reactive samples from 38 primary screening laboratories in Panyu District,Guangzhou (March 2024-October 2025). Derived from this cohort and supplemented for statistical power,138 validation samples were categorized into four groups: Western Blot (WB) positive group[WB(+), (n = 30)], double-negative by third/fourth generation enzyme-linked immunosorbent assay [3rd/4th ELISA (-/-),(n = 71)], WB-negative/indeterminate with positive nucleic acid test [WB(±/-)NAT(+), (n = 21)] and WB-negative/indeterminate with negative NAT[WB(±/-)NAT(-),(n = 16)]. Samples were evaluated on a Maccura i3000 analyzer before and after PEG 6000 or 2-ME treatment.
RESULTS: False-positive rates inversely correlated with cut-off Index (COI) value, reaching 96.30% in the 1.0-15.0 range.In the 3rd/4th ELISA (-/-) group, PEG 6000 and 2-ME achieved 100% and 97.18% negative conversion, respectively. Critically, in the WB(±/-)/NAT(+) subgroup (early infections), PEG 6000 erroneously eliminated true-positive signals, dropping diagnostic concordance to 42.86% (9/21). Conversely, 2-ME safely maintained 100% (21/21) concordance(p < 0.001).Although overall concordance across the entire cohort did not differ significantly (p = 0.143), this aggregate analysis masked 2-ME's vital superiority in specific subgroups.
CONCLUSIONS: 2-ME pretreatment is superior to PEG 6000 for triaging low-positive HIV results, effectively reducing false positives while preserving critical early-infection signals. This simple strategy enhances the efficiency and accuracy of high-volume HIV screening.
METHODS: We retrospectively analyzed 589 initially reactive samples from 38 primary screening laboratories in Panyu District,Guangzhou (March 2024-October 2025). Derived from this cohort and supplemented for statistical power,138 validation samples were categorized into four groups: Western Blot (WB) positive group[WB(+), (n = 30)], double-negative by third/fourth generation enzyme-linked immunosorbent assay [3rd/4th ELISA (-/-),(n = 71)], WB-negative/indeterminate with positive nucleic acid test [WB(±/-)NAT(+), (n = 21)] and WB-negative/indeterminate with negative NAT[WB(±/-)NAT(-),(n = 16)]. Samples were evaluated on a Maccura i3000 analyzer before and after PEG 6000 or 2-ME treatment.
RESULTS: False-positive rates inversely correlated with cut-off Index (COI) value, reaching 96.30% in the 1.0-15.0 range.In the 3rd/4th ELISA (-/-) group, PEG 6000 and 2-ME achieved 100% and 97.18% negative conversion, respectively. Critically, in the WB(±/-)/NAT(+) subgroup (early infections), PEG 6000 erroneously eliminated true-positive signals, dropping diagnostic concordance to 42.86% (9/21). Conversely, 2-ME safely maintained 100% (21/21) concordance(p < 0.001).Although overall concordance across the entire cohort did not differ significantly (p = 0.143), this aggregate analysis masked 2-ME's vital superiority in specific subgroups.
CONCLUSIONS: 2-ME pretreatment is superior to PEG 6000 for triaging low-positive HIV results, effectively reducing false positives while preserving critical early-infection signals. This simple strategy enhances the efficiency and accuracy of high-volume HIV screening.