MAGLUMI HIV Ab/Ag Combi CLIA Assay (4th-Generation) is CE Marked (List A) - A good quality solution to the early diagnosis of HIV infection

Release Date:2021-04-14

Shenzhen, China, 14 April 2021 - Snibe received the CE certificate (List A) for the HIV Ab/Ag Chemiluminescence Immunoassay (CLIA) assay. CE List A is the highest level of CE certification, which requires that the entire product performance verification process needs to be independently completed in Europe by a third party, and the results also need to be compared with the excellent products of the EU. It indicates that MAGLUMI® HIV Ab/Ag Combi CLIA kit has totally met EU standards of performance, quality and safety, and can be sold in European markets.

HIV, its full name called the human immunodeficiency virus, which remains a major global public health problem, killing nearly 33 million people to date. Early diagnosis plays an essential role in the effective treatment of HIV and in increasing the survival rate of HIV patients. In the early stage of infection, the infected person usually has no specific clinical manifestations, and the HIV cannot be detected by conventional antibody detection methods, resulting in further spread of the virus. Adopting effective methods to detect early-stage infections and providing intervention and treatment are of great significance to individual and public health. 

The laboratory testing guideline from US CDC reports that HIV-1 p24 antigen is expressed and quantities rise to a level that can be detected by 4th generation immunoassays within 4 to 10 days after the initial detection of HIV-1 RNA. Next, immunoglobulin (Ig) M antibodies are expressed which can be detected by 3rd and 4th generation immunoassays 3 to 5 days after p24 antigen is first detectable, 10 to 13 days after the appearance of viral RNA [1].


Sequence of appearance of laboratory markers for HIV-1 infection [1]


MAGLUMI® HIV Ab/Ag Combi CLIA assay is the 4th generation HIV assay, which can reduce the detection window period by detecting not only 

HIV-1/2 antibodies but also the p24 antigen. 

MAGLUMI® HIV Ab/Ag Combi CLIA Kits (50T &100T)


MAGLUMI® HIV Ab/Ag Combi CLIA assay has an excellent clinical performance validated by the third-party independent laboratory in Germany, 

including:

    ✔ 100% clinical sensitivity for the positive samples of HIV-1 p24, Anti-HIV-1 and Anti-HIV-2
    ✔ 99.98% clinical specificity for blood donor samples
    ✔ Equal or more sensitive than most commercial assays in the seroconversion panels detection
    ✔ Analytical sensitivity of 0.7695 IU/mL when testing the NIBSC HIV-1 p24 antigen (NIBSC code: 90/636, ≤ 2.0 IU/mL)
    ✔ No cross-reaction with common potential interferent
    ✔  Validated different types of sample collecting tube
    ✔ Capable to detect various groups of HIV 

Snibe as one of the global pioneers in IVD field, receiving the CE List A certificate of HIV Ab/Ag Combi is just the first step. Snibe is committed to pursuing

the high quality of our products as the foundation of entrepreneurship. More good news is coming soon as more MAGLUMI® assays continuing to receive 

CE List A certificate.


 [1] Branson BM,Owen SM,Wesolowski LG, et al. Laboratory Testing for the Diagnosis of Hiv Infection: Updated Recommendations[J], 2014.