In the rapidly evolving field of medical diagnostics, QL Biotech stands at the forefront with its innovative solution: the Human Immunodeficiency Virus (HIV) Antibody (Ab) and P24 Antigen (Ag) Rapid Test Device. This cutting-edge testing kit is a vital tool in the fight against HIV, offering a convenient, reliable method for early detection of the virus in whole blood, serum, or plasma samples. The significance of early HIV detection cannot be overstated. Timely diagnosis is crucial for initiating antiretroviral therapy (ART), which can significantly slow the progression of the disease, reduce the risk of transmission, and improve quality of life for infected individuals. This is where our HIV AG Rapid Test Device comes into play, designed to meet the critical needs of healthcare providers and their patients with speed, accuracy, and reliability.

• ● 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)

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.

 

Our test leverages a sophisticated, membrane-based immunoassay technology to qualitatively detect the presence of antibodies to HIV types 1 and 2, as well as the P24 antigen, within a remarkably short time frame. This dual detection capability enhances the test's sensitivity and specificity, making it an invaluable asset in the early stages of HIV infection when P24 antigen levels are particularly high even before antibodies are fully detectable. The simple, user-friendly design of our test kit ensures that it can be administered with ease in a variety of settings, from advanced diagnostic labs to remote field locations, providing critical support in global efforts to curb the spread of HIV. With the HIV AG Rapid Test Device by QL Biotech, early detection is now more accessible than ever, empowering healthcare professionals and patients alike with the knowledge needed to take timely action.