Serodia HIV12 agglutination test Fujirebio Inc Japan is a reliable rapid test available in the market for quite some time but has been recently replaced by a newer version SerodiaHIV12 MIX ID: 1032977
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1. Background:Sensitive rapid test for HIV is essential for community-based testing.Serodia HIV-1/2 agglutination test (Fujirebio Inc., Japan) is a reliable rapid test available in the market for quite some time but has been recently replaced by a newer version, Serodia-HIV1/2 MIX. Serodia-HIV1/2 MIX uses recombinant HIV antigens instead of viral lysate like in the older version. In this study, we compared the newer version with the older version of which the Thai Red Cross Anonymous Clinic had used for over a decade.Test performance of the new version of Serodia agglutination test in HIV-1 infected Thai patientsSupanit Pattanachaiwit1, Tippawan Pankam1, Chanthipa Arsaman1, Supphachoke Areeyolwattana1, Sunee Sirivichayakul2, Praphan Phanuphak1, 21 The Thai Red Cross Anonymous Clinic, Bangkok, Thailand, 2 Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, ThailandPRESENTED AT THE 23RD INTERNATIONAL AIDS CONFERENCE (AIDS 2020) | 6-10 JULY 2020Results:Of the 50 HIV-negative samples, Serodia HIV-1/2 gave negative results in all samples but Serodia-HIV1/2 MIX showed indeterminate results in 2. Of the 50 samples with established infections, Serodia HIV-1/2 correctly diagnosed all but Serodia-HIV1/2 MIX showed indeterminate results in 6. Of the 40 AHI samples, Serodia HIV-1/2 could not detect any but Serodia-HIV1/2 MIX could diagnose 3 samples but again showed 1 indeterminate result (Table 1).Table 1 Comparison of Serodia-HIV1/2 MIX (new version) with Serodia HIV-1/2 (old version)* Indeterminate result was defined by sample agglutination with both control and sensitized particles.Substantial agreement was found between 2 Serodia test kits ( = 0.73 (0.61-0.80), p values < 0.001). Conclusions: Although both Serodia test kits had concordant results, the new version, Serodia-HIV1/2 MIX was slightly more sensitive since it could detect 3/40 (7.5%) of antibody-negative AHI. However, the newer version had many indeterminate test results which required additional work as semi-quantitative assay with 2-fold sample dilution from 1:4 to 1:8192 according to recommendation.Methods :A total of 140 plasma samples (50 HIV-negative, 50 established HIV infections and 40 acute HIV infections (AHI)) were included in the study. Established HIV infection was defined by positive screening with Architect HIV Ag/Ab Combo test, confirmed by Alere Determine HIV-1/2 and Serodia HIV-1/2 tests (the old version). AHI was defined by positive screening test, HIV-RNA positive, but both confirmatory tests were negative.All specimens were simultaneously tested by Serodia-HIV1/2 MIX (the new version) and Serodia HIV-1/2 (the old version). Any discrepancies were re-tested to confirm the results. Statistical differences between 2 test kits were calculated by Kappa statistic test. Sample TypeSerodia-HIV1/2 MIX (new version)Serodia HIV-1/2 (old version)Non-ReactiveReactiveIndeterminate*Non-ReactiveReactiveIndeterminateHIV-Negative48025000Established HIV Infection04460500AHI36314000Total8447990500PEB0103