[A system review on the application of BED-capture enzyme immunoassay in detecting new HIV-1 infection].

Objective: To study whether BED-capture enzyme immunoassay (CEIA) is feasible to be used in wide-ranging population, we collect papers and conference abstracts related to BED-CEIA and HIV-1 incidence.

Methods: 10 papers are included for the discussion, regarding the concordance between the estimated HIV-1 incidence from BED-CEIA and the results from a cohort studies; and 11 papers are selected to discuss the related misclassification on the estimation of HIV-1 incidence.

Results: Concordance between the two sets is related to the districts and design of research. Results from Africa are not so satisfactory, but researches, those BED-CEIA samples are collected during the follow-up of the cohort study, have shown better outcomes than other ones. There are totally 7303 samples of LTI (long-term infections) collected for analyzing the misclassification of BED-CEIA. 432 LTI are misclassified as new infections, making the raw rate of misclassification as 5.9% with 95% confidential interval between 5.36 and 6.44. Data from systematic review shows that the BED-CEIA's misclassification rate relates to the count of CD4(+)T lymphocytes and time after the infection but has no relation to the classification of sub-populations (female sexual workers and intravenous drug users in China) and districts (China and Africa).

Conclusion: Our results reveal that the misclassification is relevant to the immune-status of the infected persons.