Intended Use

This product is used for the qualitative determination of human immunodeficiency virus type I (HIV-1) antibodies and type II (HIV-2) antibodies in human urine samples. It is suitable for the auxiliary diagnosis of HIV infection. The test results are only for clinical reference and cannot be used alone as the basis for confirming or excluding cases. In order to achieve the purpose of diagnosis, the test results should be used in conjunction with clinical examination, medical history and other examinations. This product can be used for consumer self-test.

Product Information

Testing Method

Allow the test box to equilibrate to room temperature prior to testing.

1. Remove the test card from the sealed foil bag. Use within 1 hour after opening.
2. Place the test apparatus on a clean, level surface.
3. Aspirate the urine sample with the provided dropper, add 3 drops (approx. 100ul) to the sample well.
4. Read results after 15 minutes. Results after 20 minutes are not convincing.

Explanation of Test Results

Negative: Only the C line is present. HIV-1/2 antibodies not detected.

Positive: Both C-line and T-line are present. Indicates presence of HIV-1/2 antibodies.

Invalid: Control line (C) does not appear. The test must be repeated.

1. Minimum detection amount: 0.2NCU/ mL.

2. Sensitivity: 100% positive detection rate for HIV-1 and HIV-2 reference samples.

3. Specificity: 96.2% negative coincidence rate in clinical urine samples.

4. Precision: 100% coincidence rate in continuous testing over 20 days.

5. Cross reaction: No cross reaction with Syphilis, Hepatitis B/C, Flu A/B, COVID-19, etc.

6. HIV subtypes detected: Detects HIV-1 (type A, B, C, E, O) and HIV-2.

Limitations

• Clinical auxiliary use only; not for standalone confirmation.
• Negative results do not rule out infection during the window phase.
• Antiviral treatment may cause false negatives.
• Only validated for urine samples.