In the realm of medical diagnostics, timely and accurate detection of infectious diseases is crucial for effective treatment and management. QL Biotech stands at the forefront of this battle against time and uncertainty with its revolutionary product: the Human Immunodeficiency Virus (HIV) Antibody & P24 Antigen (Ag) Rapid Test Device, designed for the simultaneous detection of Malaria PF alongside HIV. This state-of-the-art diagnostic tool embodies cutting-edge technology to provide reliable results in just a matter of minutes, using whole blood, serum, or plasma samples.

• ● 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 essence of this device lies in its innovative dual-detection system. It is not merely a tool for identifying HIV 1&2 and P24 antigen but is ingeniously integrated with the capability to detect the Plasmodium falciparum (PF), responsible for the most dangerous form of malaria. This integration is especially critical in regions where both diseases are prevalent, offering a cost-effective and time-saving solution for healthcare professionals and patients alike. The principle of the test is grounded in a qualitative, membrane-based immunoassay, ensuring high sensitivity and specificity. The practicality of QL Biotech's Rapid Test Device is unmatched. Designed for use in a wide range of settings, from sophisticated laboratories to remote field clinics, its ease of use does not compromise the accuracy or reliability of results. Upon introduction of the sample into the test device, results are available in a remarkably short period, empowering healthcare providers with the information needed to make informed decisions regarding treatment and care. This rapid turnaround is vital for containing outbreaks and significantly impacts the management of diseases within communities, making QL Biotech’s product an indispensable tool in global health efforts.