Objective To evaluate the performance of i3000 direct chemiluminescence detection of human immunodeficiency virus (HIV) antigen and antibody (Ag/Ab) screening assay (Maccura), compared with E170 electrochemiluminescence method (Roche, Elecsys? HIV Combi PT assay) and IS1200 indirect chemiluminescence method (Maccura). Methods Ten HIV seroconversion panels and 11 p24 antigen positive samples from West China Hospital of Sichuan University from April to December 2017 were used to evaluate the sensitivity of those three assays. A total of 351 samples were collected for consistency evaluation, including 350 HIV Ag/Ab test samples (200 HIV-1 positive plasma samples and 150 HIV 1+2 negative plasma samples) from West China Hospital of Sichuan University from April to December 2017, and one commercial HIV-2 sera. A total of 98 interfere samples for HIV testing were collected from West China Hospital of Sichuan University from April to December 2017. Results In the sensitivity evaluation, there were 63 samples from the 10 seroconversion panels, in which Roche E170 detected 25 samples, Maccura i3000 detected 23 samples, and Maccura IS1200 detected 22 samples; Maccura i3000 and Roche E170 assays detected all the p24 antigen positive samples (11, 100%), while Maccura IS1200 only detected 10 samples. In the consistency evaluation, Maccura i3000 had nice consistency with both Roche E170 and Maccura IS1200 (kappa>0.9, P<0.001). In the interference evaluation, there were two false positives in Maccura i3000 detection, one case of rheumatoid arthritis and one case of syphilis. Conclusion In addition to high throughput and good consistency, Maccura i3000 direct chemiluminescence reagent has high sensitivity and a short window period, which can meet clinical needs.
Objective To evaluate the performance of a novel magnetic particle-based chemiluminescence reagent for detecting cryptococcal capsular polysaccharide. Methods Serum and cerebrospinal fluid specimens were collected from patients with suspected cryptococcal infection at West China Hospital, Sichuan University between July 2022 and September 2023. All samples were simultaneously tested by chemiluminescence immunoassay (CLIA) and lateral flow immunoassay (LFA), and the results of the two methods were compared. Results A total of 357 patients with suspected cryptococcal infection were enrolled, including 247 serum samples and 110 cerebrospinal fluid samples. The novel magnetic particle-based CLIA reagent exhibited favorable clinical performance for cryptococcal infection detection. For serum and cerebrospinal fluid specimens, the sensitivity was 96.95% and 100.00%, respectively; the specificity was 99.14% and 100.00%, respectively. It showed high consistency with the LFA reagent (the kappa values were both greater than 0.98 for serum and cerebrospinal fluid samples). Moreover, the CLIA reagent enables quantitative measurement for clinical therapeutic monitoring. Conclusion The novel magnetic particle-based CLIA reagent possesses good diagnostic performance and can provide reliable and supportive laboratory evidence for clinical practice in both early diagnosis and therapeutic monitoring.