28th April 2021  Product update: rapidvirology staff writer

HIV Ab/Ag Chemiluminescence Immunoassay (CLIA) Receives CE-Marking


Snibe has announced its HIV Ab/Ag Chemiluminescence Immunoassay (CLIA) has received CE-List A marking.

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.

It indicates that the MAGLUMI® HIV Ab/Ag Combi CLIA kit has met EU standards of performance, quality, and safety and can be sold in European markets.

HIV 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 increasing the survival rate of HIV patients.

In the early stage of infection, the infected person usually has no specific clinical manifestations, and 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 the 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

2117_SnibeDiagnostics

Diagram: Sequence of laboratory markers for HIV-1 infection

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 assay has an excellent clinical performance validated by the third-party independent laboratory in Germany showing:

  • 100% clinical sensitivity for 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 using seroconversion panel 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 interferent
  • Validated using different types of sample collecting tube
  • Capable of detecting various groups of HIV

References: 

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

Please contact us for further information on pricing & availability.


    

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Date Published: 28th April 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.


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