In the fast-paced medical field, where time and accuracy are of the essence, QL Biotech introduces the groundbreaking Human Immunodeficiency Virus (HIV) Antibody and P24 Antigen (Ab & P24 Ag) Rapid Test Device. This innovative diagnostic tool is designed for the dual detection of HIV 1&2 antibodies as well as the P24 antigen in whole blood, serum, or plasma samples, providing a comprehensive and efficient screening solution in a single test.

• ● 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.

 

The technology behind our Rapid Test Device leverages a sophisticated, membrane-based immunoassay, meticulously engineered to offer qualitative results with unparalleled precision. By targeting both antibodies to HIV 1&2 and the P24 antigen, the test encompasses a critical early marker of HIV infection, thereby facilitating an early diagnosis which is crucial for effective management and treatment of the virus. The ease of use, combined with the rapid turnaround time for results, positions this device as an indispensable tool in both clinical and field settings, ensuring that individuals have swift access to crucial health information. At the core of our device's innovation is its ability to integrate seamlessly into a variety of testing scenarios, from hospital laboratories to remote field clinics, without the need for complex equipment or extensive training. This adaptability, paired with the device's robust performance, underscores QL Biotech's commitment to advancing healthcare solutions that are not only scientifically advanced but also accessible and practical for widespread use. In adopting our HIV Ab & P24 Ag Rapid Test Device, healthcare providers can significantly enhance their screening processes, ensuring that individuals at risk of HIV receive timely and accurate diagnoses, thereby contributing to the broader goal of managing and controlling the spread of HIV. With the additional focus on paralleling advances in the Malaria PF Test field, this device exemplifies our dedication to bridging critical gaps in infectious disease diagnostics.