The characteristics of screening and confirmatory test results for HIV in Xi’an, China

Wang, Linchuan; Zhou, Kaihua; Zhao, Heping; Wang, Ji-Han; Zheng, Haichao; Yu, Yan; Chen, Wei

doi:10.1371/journal.pone.0180071

Cited by 6 publications

(5 citation statements)

References 33 publications

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“…Moreover, of the 217 repeatedly reactive cases by the assay, 46.08% were found to be FP. We found that the FP rate decreased as the test values increased [14, 33]. For ARCHITECT HIV Ag/Ab Combo, the FP rate was 100% at 1–10 of COI, but the FP rate decreased to 0 when the COI was ≥30.…”

Section: Discussionmentioning

confidence: 99%

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HIV infection in Xi’an, China: epidemic characterization, risk factors to false positives and potential utility of the sample-to-cutoff index to identify true positives using Architect HIV Ag/Ab combo

Wang

Xiao

Tian

et al. 2019

Antimicrob Resist Infect Control

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BackgroundIn China, although tremendous efforts has been made, the HIV/AIDS is still not controlled.ObjectivesThe study was carried out to determine the epidemic of HIV infection in Xi’an, analyse false positives (FP) risk factors and potential utility of sample-to-cutoff index to identify true positives using Architect HIV Ag/Ab Combo.MethodsA retrospective review for HIV screening by Architect HIV Ag/Ab Combo was performed in a teaching hospital in Xi’an between 2015 and 2016. The prevalence of HIV, positive predictive value (PPV) at different cut-off indexices (COI) were calculated. The epidemic of infections and risk factors for FP results were investigated.ResultsIn the study, the HIV prevalence and FP rate of Architect HIV Ag/Ab Combo were 0.076 and 46.08%, respectively. The Han Chinese, males and people aged < 40 years accounted for the majority of infections (98.29, 76.07 and 73.5%, respectively). 85.47% of the infections were transmitted through sexual contact (35.04% of male homosexual and 50.43% of heterosexual). COI at 1–10, 10–30 and ≥ 30, the PPVs were 0, 50 and 100%, respectively. The independent risk factors for FP, i.e., pregnancy and malignancy had a statistically significant association with FP (p < 0.05), and age had a very strong statistically significant association with FP (p < 0.001).ConclusionsIn Xi’an, sexual contact was the most important transmission mode for HIV, and the infections were predominantly identified in Han Chinese, males, young and middle-aged people. For Architect HIV Ag/Ab Combo, it can achieve 100% of PPV with COI ≥30, and the age was strongly statistically associated with FP.

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Section: Discussionmentioning

confidence: 99%

“…New and recent HIV infections are more infectious than chronic infections [11–14], thus early identification of HIV infection is crucial to prevent HIV transmission [15]. The algorithm requires a sequence of tests to identify HIV infection for the repeatedly reactive subjects.…”

Section: Introductionmentioning

confidence: 99%

HIV infection in Xi’an, China: epidemic characterization, risk factors to false positives and potential utility of the sample-to-cutoff index to identify true positives using Architect HIV Ag/Ab combo

Wang

Xiao

Tian

et al. 2019

Antimicrob Resist Infect Control

Self Cite

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“…However, for cases with low COI values (e.g., COI = 1.0–15.0), most were false-positive, and a few had early HIV infections. It is difficult to distinguish false-positives and early HIV infections using western blotting because false-positives may also show positivity for the P24 antigen or other single antibody band caused by crossreaction; the patient must be followed up for 1, 3, or even 6 months to reconfirm the results 6 , 8 , and this can waste a lot of manpower, materials, and financial resources. Moreover, there may be a delay in the diagnosis and treatment of the patient, which could cause a heavy psychological burden to the patient 16 , 17 .…”

Section: Discussionmentioning

confidence: 99%

A method to alleviate false-positive results of the Elecsys HIV combi PT assay

Minghong²,

et al. 2021

Sci Rep

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To explore the effects of urea dissociation on reducing false-positive results of the Elecsys HIV combi PT assay. A retrospective analysis was used to evaluate the false-positive rate of the Elecsys HIV combi PT assay. Six false-positive sera, six positive sera and six sera from patients with early HIV infection were collected. Dissociation was performed using 1 mol/L, 2 mol/L, 4 mol/L, 6 mol/L, or 8 mol/L urea, and HIV screening assay were then detected to select the appropriate concentration of urea dissociation. Next, 55 false-positive sera and 15 sera from early HIV infection were used to verify the best concentration of urea to achieve dissociation. Retrospective analysis showed that the COI of the Elecsys HIV combi PT assay in false-positive sera ranged from 1.0 to 200.0, and approximately 97.01%(227/234) of false-positive sera were in the range of 1.0–15.0. The avidity index (AI) in positive and false-positive sera decreased as the urea dissociation concentration increased. When the dissociation concentration was 6 mol/L, the AI of false-positive serum was between 0.0234 and 0.2567, and the AI of early HIV infection sera was between 0.4325 and 0.5017. The difference in AI between false-positive and positive samples was significant. When negativity was defined as an AI of less than 0.3970, the sensitivity and specificity were 100.0% and 100.0%, respectively. Urea-mediated dissociation could significantly reduce the false-positive rate of the Elecsys HIV combi PT assay with a low COI. Our findings provided a reference for distinguishing positive and false-positive of the Elecsys HIV combi PT assay.

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Section: Introductionmentioning

confidence: 99%

“…Recently, many studies show that there was an association between test values and subsequent confirmatory results. As COI values increased, the number of FP decreased, and the possibility of positive results was higher [ 13 , 26 , 27 ]. Thus, the present study was carried out to evaluate the performance of Elecsys® HIV combi PT assay in a large cohort of patients from 2018 to 2019 in Nanjing, a low-HIV-prevalence region of East China, to analyze the sensitivity, specificity, and positive predictive value (PPV) at different COI, and to seek for an optimal cutoff that can predict HIV infection at early period.…”

Section: Introductionmentioning

confidence: 99%

An Analysis of Predictive Sample-to-Cutoff Index for HIV Infection Confirmation Using Elecsys® HIV Combi PT Assay

Xia

Zhang

Zhou

et al. 2022

International Journal of Clinical Practice

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Background. Early and rapid diagnosis is crucial in HIV preventing and treatment. However, the false-positive rate (FPR) by 4-th generation detection assays was high in low-HIV-prevalence regions. Objectives. To analyze the relation between sample-to-cutoff index (COI) and HIV confirmatory results, and to explore a new COI threshold in our own laboratory to predict HIV infection. Methods. We retrospectively analyzed primarily reactive results by Elecsys® HIV combi PT assays and their confirmatory results by western blot (WB) at Nanjing Center for Disease Control and Prevention (CDC). The mean COI values of true positive (TP), false positive (FP), and indeterminate groups were compared, and receiver operating characteristic curve (ROC) analysis was performed to determine the optimal COI value for predicting HIV infection. Results. Totally 150,980 HIV serological results were reviewed, and 305 (0.2%) were primarily reactive. There are 82 (26.89%) true positives, 210 (71.92%) false positives, and 11 indeterminate samples confirmed by WB tests, and another 2 patients rejected WB tests. Mean COI values of TP (643.5) were greatly higher than that of FP (3.174) ( P < 0.0001 ), but there is no significant difference between FP and indeterminate groups. Combining the requirement of HIV diagnosis and ROC analysis, 9.87 was established as the optimal threshold to predict the infection, with 100% sensitivity and 99.99% specificity. Conclusions. By adjusting the COI threshold, the FP samples can be reduced and the efficiency of screening assays can be increased, which can save much additional reagent and staff costs and much time for delivery of HIV test results.

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The characteristics of screening and confirmatory test results for HIV in Xi’an, China

Cited by 6 publications

References 33 publications

HIV infection in Xi’an, China: epidemic characterization, risk factors to false positives and potential utility of the sample-to-cutoff index to identify true positives using Architect HIV Ag/Ab combo

HIV infection in Xi’an, China: epidemic characterization, risk factors to false positives and potential utility of the sample-to-cutoff index to identify true positives using Architect HIV Ag/Ab combo

A method to alleviate false-positive results of the Elecsys HIV combi PT assay

An Analysis of Predictive Sample-to-Cutoff Index for HIV Infection Confirmation Using Elecsys® HIV Combi PT Assay

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