Adeno Rapid Diagnostic Test: HIV Ab & P24 Ag Rapid Detection Mechanism

Short Description:

Human Immunodeficiency Virus (HIV) Ab & P24 Ag Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for the qualitative detection of antibodies to HIV 1 and/or HIV 2 and P24 antigen in whole blood, serum or plasma.


Product Detail

Product Tags

Introducing the Adeno Rapid Diagnostic Test, a revolutionary development in the field of biotechnology by QL Biotech. This advanced test device is designed to detect the presence of antibodies reacting to HIV 1&2 and the P24 antigen. It operates on a qualitative membrane-based immunoassay method which allows the device to be compatible with various sample types including whole blood, serum, and plasma. Our Adeno Rapid Diagnostic Test is a testament to our commitment to empowering medical professionals and patients with quick, reliable diagnostic tools. The science behind this test revolves around the detection of HIV antibodies and P24 antigen in the applied sample, making it a valuable tool in diagnosing and monitoring HIV infections. It is designed for efficiency and accuracy, ensuring the generation of dependable results for informed decision-making.

PRINCIPLE

Human Immunodeficiency Virus (HIV) Ab & P24 Ag Rapid Test Device (Whole Blood/Serum/Plasma) is a qualitative, membrane based immunoassay for the detection of antibodies to HIV 1&2 and P24 antigen in whole blood, serum or plasma. The membrane is precoated with recombinant HIV antigens to HIV 1&2 antibody and P24 antibody to HIV P24 antigen. During testing, the whole blood, serum or plasma specimen reacts with HIV antigen or P24 antibody coated particles in the test strip. The mixture then migrates upward on the membrane chromatographically by capillary action and reacts with recombinant HIV antigen or P24 antibody on the membrane in the test line regions. If the specimen contains antibodies to HIV 1 and/or HIV 2 and/or P24 antigen, a colored line will appear in the test line region indicating a positive result. If the specimen does not contain HIV 1 and/or HIV 2 antibodies and/or P24 antigen, no colored line will appear in the test line region indicating a negative result. To serve as a procedural control, a colored line will always appear in the control line region indicating that proper volume of specimen has been added and membrane wicking has occurred.


MATERIALS

Materials Provided
● Test devices ● Disposable specimen droppers
● Buffer ● Package insert
Materials Required But Not Provided
● Specimen collection containers ● Lancets (for fingerstick whole blood only)
● Centrifuge (for plasma only) ● Timer
● Disposable heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)

 

DIRECTIONS FOR USE

    • ● Test devices 
      ● Disposable specimen droppers 
      ● Buffer 
      ● Package insert 
      Materials Required But Not Provided 
      ● Specimen collection containers 
      ● Lancets (for fingerstick whole blood only) 
      ● Centrifuge (for plasma only) 
      ● Timer 
      ● Disposable heparinized capillary tubes and dispensing bulb (for fingerstick whole blood only)


    PERFORMANCE CHARACTERISTICS

    Sensitivity

    Human Immunodeficiency Virus (HIV) Ab & P24 Ag Rapid Test Device (Whole

    Blood/Serum/Plasma) has been tested by anti-HIV 1 low titer performance panel, anti-HIV 2 performance panel and anti-HIV 1 seroconversion panel (Boston Biomedica, Inc.). And it has also been compared with leading commercial EIA HIV test on clinical specimens. The results show that

    HIV 1&2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma) is very sensitive to HIV 1 and/or HIV 2 antibodies.

    Specificity

    The specificity of the test is comparable to a leading commercial HIV EIA test. Human Immunodeficiency Virus (HIV) Ab & P24 Ag Rapid Test Device (Whole Blood/Serum/Plasma) is highly specific for anti-HIV 1 and/or HIV 2 compared to a leading commercial HIV EIA test.

    Relative Sensitivity: 99.9% (99.3%-100.0%)*Relative Specificity: 99.6% (99.1%-99.9%)*

    Relative Accuracy: 99.8% (99.4%-99.9%)* * 95% Confidence Interval

    Precision

    Intra Assay

    Within-run precision has been determined by using 15 replicates of three specimens: a negative, a low positive and a high positive. The negative, low positive and high positive values were correctly identified 99.5% of the time.

    Inter-Assay

    Between-run precision has been determined by 15 independent assays on the same three specimens: a negative, a low positive and a high positive. Three different lots of Human

    Immunodeficiency Virus (HIV) Ab & P24 Ag Rapid Test Device (Whole Blood/Serum/Plasma) have been tested using negative, low positive and high positive specimens. The specimens were correctly identified 99.5% of the time.

     



    The core principle of the Adeno Rapid Diagnostic Test involves the use of a membrane-based immunoassay, a technique renowned for its highly sensitive detection capabilities. This cutting-edge testing methodology enables the rapid detection of antibodies and antigens, providing results that form the crux of medical diagnosis and subsequent treatment plans. To sum up, our Adeno Rapid Diagnostic Test offers a dependable solution for rapid HIV diagnostics. Its versatile compatibility with multiple types of samples —whole blood, serum, and plasma— underscores its practicality in diverse testing situations. With its qualitative detection capabilities, it stands as a beacon of hope and a significant step forward in combating HIV. Trust the Adeno Rapid Diagnostic Test from QL Biotech for rapid and reliable HIV diagnostics.

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