NEW YORK ─ Snibe Diagnostic said on Wednesday that it has obtained CE marking for its Maglumi HIV Ab/Ag Combi CLIA kit, a fourth-generation chemiluminescence immunoassay that detects HIV-1 and HIV-2 antibodies and the HIV-1 p24 antigen, enabling its sale in the European Union and other regions that accept the designation.
Shenzhen, China-based Snibe said that an independent laboratory in Germany validated its assay's clinical performance and found 100 percent sensitivity for detecting HIV-1 p24, anti-HIV-1, and anti-HIV-2 in positive samples. The test also had an analytical sensitivity of 0.7695 IU/mL in detecting the HIV-1 p24 antigen, Snibe said.
It noted that according to US Centers for Disease Control and Prevention laboratory testing guidelines, HIV-1 p24 antigen quantities rise to levels that can be detected by fourth-generation immunoassays within four to 10 days after the initial detection of HIV-1 RNA. Immunoglobulin (Ig) M antibodies are then expressed and can be detected by third- and fourth-generation immunoassays three to five days after p24 antigen is first detectable, and 10 to 13 days after the appearance of viral RNA.
In March, Snibe announced it had received CE-IVD marking for its Maglumi SARS-CoV-2 Ag antigen test.