The false-positive and false-negative predictive value of HIV antibody test in the Chinese population

Abstract

Evaluation of HIV prevalence through the HIV-Ab positive rate by third ELISA will significantly overestimate the true prevalence in a low-prevalence population. Individual HIV-infection status should be taken into consideration when analysing the results of HIV-Ab tests in a population with low infection.

Bayesian evaluation of the human immunodeficiency virus antibody screening strategy of duplicate enzyme‐linked immunosorbent assay in Xuzhou Blood Center, China

“…In this study, among the 219 anti‐HIV–positive donations screened by the duplicate ELISA algorithm under evaluation, 212 were determined to be false positive by the confirmatory procedure consisting of a WB test and a consequent follow‐up; as a result, the FPPV among the voluntary blood donors (212/219, 96.8%) and the HIV prevalence in the study population ([219 − 212]/234,602, 0.00298%) were elicited (the HIV prevalence is actually not accurate because it does not allow for the failure of picking up anti‐HIV in blood donations by both ELISA tests, but the duplicate ELISA algorithm plus the confirmatory procedure in this study is considered to be a “gold standard” here and now as is conventionally done; therefore, the HIV prevalence estimated here is comparable to those in the following studies). The FPPV in this study is much higher than those reported in our previous study, 23 in which the FPPVs were 77.605 and 32.011% among sex workers and among drug users, respectively. We believed that the reason for the difference is the discrepancy between the HIV prevalences in the screened populations.…”

Parallel enzyme‐linked immunosorbent assay screening for human immunodeficiency virus among blood donors in five Chinese blood centres: a retrospective analysis

“…At such a rate, we would expect that 4254 (80% out of 5318) discarded donations in our study to be false positive. In fact, the overall PPV among one or two round ELISA reactive samples in other regions in China such as Jiangsu (11/2439, 0·45%) (Liu et al , ), Shanxi (1·91%, 8/419) (GWN, ) and Chongqing (7·11%, 43/604) (Wang et al , ) were even lower than that in this study (16·2%, 271/1668), suggesting an even higher false positive rate. Consequently, the estimated cumulative number of blood units discarded and the number of otherwise eligible donors who were permanently deferred due to ELISA screening results in China in the past decades would be substantial.…”

Analysis of HTLV‐1 proviral load (PVL) and antibody detected with various kinds of tests in Japanese blood donors to understand the relationship between PVL and antibody level and to gain insights toward better antibody testing

“…When CLEIA and PA were used to evaluate antibody presence, the NAT‐positive sample proportion was also higher in Kyushu than in Tokyo‐Chiba. In general, if a test's false‐positive rate is constant among non‐infected individuals, the ratio of true‐positive samples to false‐positive samples in the general population should be higher in areas of endemic HTLV‐1 infection than in non‐endemic areas . This phenomenon has been called the “false positive paradox.” Therefore, testing with CLIA may yield relatively fewer false‐positive results, because the NAT‐positive sample proportion among CLIA‐positive samples was almost the same in Kyushu (94.1%) and Tokyo‐Chiba (96.7%).…”

“…The blood samples were donated in Tokyo‐Chiba, which has a low prevalence of HTLV‐1 infection, and in Kyushu, which has a high prevalence of HTLV‐1 infection . Blood was collected from these different regions because some differences were expected, especially in the antibody test results count of false positive rates, between endemic and non‐endemic areas . By analyzing the relationship between antibody titer and PVL, a clinically important subpopulation that mainly consisted of male donors with low antibody titers and high PVLs was identified.…”

“…9 Blood was collected from these different regions because some differences were expected, especially in the antibody test results count of false positive rates, between endemic and non-endemic areas. 14 Informed consent for participation in this and other blood safety surveillance studies on transmissible infections was obtained from each donor during each blood donation. This study was conducted according to the principles in the Declaration of Helsinki.…”