Rapid Malaria PF Test - QL Biotech's Innovative HIV Ab & P24 Ag Detection Device

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

As a trusted and reliable name in biotech, QL Biotech introduces the Malaria PF Test - a Rapid Test Device for the identification of HIV Ab & P24 Ag. This groundbreaking device works through a qualitative, membrane-based immunoassay enabling the user to detect antibodies specific to HIV 1&2 and P24 antigen. Designed to function with whole blood, serum, or plasma, the Malaria PF Test offers unparalleled efficiency and dependability. The principle of operation is rooted in the immunoassay method, which makes this tool a critical instrument in the field of health and disease detection. The Malaria PF Test is designed with a specific focus on user friendliness and quick results, offering a speedy and precise analysis. As the importance of early diagnosis in HIV infection cannot be overstated, the device plays a significant role in ensuring timely intervention and treatment.

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 Malaria PF Test device is a testament to QL Biotech's commitment to creating cutting-edge solutions in disease diagnosis and management. By providing a rapid detection method for HIV Ab & P24 Ag, QL Biotech not only brings a powerful tool to the medical community but also signals its pledge to promoting health and wellbeing worldwide. QL Biotech’s Malaria PF Test offers accuracy, reliability, and speed, making it an indispensable resource for healthcare professionals focused on delivering timely and effective diagnosis and treatment. It is not just a product, but a revolution in rapid HIV detection, a symbol of QL Biotech's commitment to excellence and innovation in the biotech industry. Discover the Malaria PF Test - because when it comes to accurate and rapid HIV detection, every moment matters.

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