In today's fast-paced medical field, the necessity for swift and reliable diagnostic solutions is paramount, particularly when it comes to the detection of serious viruses such as the Human Immunodeficiency Virus (HIV). QL Biotech introduces the forefront of rapid testing technology with our groundbreaking product: the HIV Antibody & P24 Antigen (Ag) Rapid Test Device, now enhanced for broader application by incorporating the Ns1/Igm/Igg Combotest Panel. This innovative device is your all-in-one solution for HIV screening, offering unparalleled precision in the detection of antibodies to HIV types 1 and 2, as well as the P24 antigen in 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.

 

Our test leverages a state-of-the-art, membrane-based immunoassay, which is designed to streamline the testing process while ensuring the utmost accuracy and reliability. The core of this device's effectiveness lies in its ability to simultaneously detect the early markers of HIV - including the critical P24 antigen, often present before antibodies are detectable - alongside the traditional antibody test. This dual-action capability ensures that individuals can receive earlier diagnosis and subsequent care, which can be crucial for managing the virus effectively. Furthermore, the inclusion of the Ns1/Igm/Igg Combotest Panel extends the device's capabilities, providing a comprehensive overview of a person's serological status with respect to HIV. This panel facilitates the differentiation between acute and later-stage infections, offering insights that are critical for clinicians to tailor individual treatment plans. By integrating this panel, our device not only caters to the urgent need for rapid HIV testing but also embodies QL Biotech's commitment to pioneering advancements in the medical diagnostic field, helping healthcare providers offer prompt and accurate care.