Offered by QL Biotech, the Toxoplasma Gondii and Human Immunodeficiency Virus (HIV) Ab & P24 Ag Rapid Test Device is an advanced and efficient solution for effective detection. This qualitative, membrane-based immunoassay is designed to detect antibodies directed against HIV 1&2, as well as the P24 antigen. The test is applicable for whole blood, serum or plasma samples, thereby making it versatile for various testing environments. The device serves as a crucial tool in early diagnosis and control of HIV and Toxoplasma Gondii, a disease that can lead to serious conditions, in particular for individuals with weakened immune systems. The rapid test device is geared to provide swift results, reducing time spent in uncertainty. It continues to consistently deliver highly accurate results in different sample types, making it a trusted option for healthcare facilities globally. With a remarkable sensitivity and specificity, the HIV Ab & P24 Ag Rapid Test Device is a significant breakthrough in medical diagnostics, providing assistance in crucial early detection. The device's easy to use design allows even untrained personnel to operate it effectively, thus further enhancing its usability.

• ● 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.

 

QL Biotech strives to provide products that can aid in quick, accurate diagnosis and contribute to improved patient care. Backed by rigorous research and extensive testing, our Toxoplasma Gondii and HIV rapid test device stands as a testament to our commitment to quality and accuracy. Trust in QL Biotech's innovation for efficient diagnosis and better health outcomes. Please note: The device should be used as a diagnostic tool in conjunction with clinical presentations and other laboratory tests to ensure accurate results. Always consult a medical professional for advice.