Singclean Rapid Early Result Urine HIV Test Kit for Self-Test

• Customization: Available
• Type: IVD Reagent
• Quality Guarantee Period: Two Years
• Model NO.: Original
• Logo Printing: OEM Brand
• Advantage: on-Site Drug Testing
• Feature: One-Step Operation
• Transport Package: Carton or Box
• Trademark: Singclean
• Origin: China
• HS Code: 3302100090
• Production Capacity: 50000/Day

Product Description

^{HIV-1/2 Antibody Urine Assay Kit (Colloidal Gold)}
 

 

Intended Use
This product is used for the qualitative determination of human immunodeficiency virus type I (HIV-1) antibodies and type II (HlV-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.

Pack Formats
1 test/box, 10tests/box, 20 tests/box, 50 tests/box

Advantages
1. Non-invasive and convenient sampling;
2. High accuracy and reliability;
3. Get results quickly;
4. User-friendly design;
5. Privacy protection;

 

 

Storage Conditions and Validity Period

1. Store at 4-30°C in a dry, dark place. Valid for 24 months.

2. Refer to the outer packaging for production and expiration dates. Do not freeze or use beyond the expiration date.

3. Once the sealed pouch is opened, use the test within 1 hour.

Testing Method

Allow the test device to reach room temperature before use.

1. Remove the test card from the foil pouch and use promptly.

2. Place the test apparatus on a clean, level surface.

3. Using the provided dropper, transfer 3 drops (approx. 100 µL) of urine into the sample well. Start the timer.

4. Read results at 15 minutes. Results beyond 20 minutes are not valid.

Explanation of Test Results

Negative:	If only the C line is present and there is no purple-red in the T line, HIV-1/2 antibodies are not detected in the specimen. The result was negative.
Positive:	In addition to the presence of a C-line, if a T-line is present, the test indicates the presence of HIV-1/2 antibodies in the sample. The result was positive.
Invalid:	Control lines do not appear. Regardless of whether there is a T line, it is an invalid result.

Performance

1. Minimum Detection: 0.2 NCU/mL

2. Sensitivity:

   • 100% detection for 200 HIV-1 antibody-positive serum samples (10× diluted in normal urine)

   • 100% detection for 50 HIV-2 positive reference samples (10× diluted in normal urine)

3. Specificity:

   • 96.2% negative agreement rate across 361 negative urine samples

4. Precision:

   • Consistent inter-batch and intra-batch performance over 20 days; 100% repeatability concordance

5. Cross-Reactivity:

   • No cross-reactivity with syphilis, hepatitis C, hepatitis B, CEA, influenza A/B, HAMA, RF, ALT, COVID-19, urine occult blood, total protein, or urinary bilirubin

6. Interfering Substances:

   • No interference from MOP, THC, COC, MET, OPI, BZO, TCA, OXY, AMP, MTD, BAR, MDMA at 200 mg/mL

   • No interference from zidovudine, Edurant, nevirapine, ritonavir, famciclovir, isoniazid at 100 mg/mL

7. HIV Subtypes Detected:

   • HIV-1 subtypes A, B, C, E, O; and HIV-2

 

Limitations of the test method

1. This kit is an auxiliary diagnostic tool. Results must be correlated with clinical evaluation and other diagnostic tests.

2. A negative result does not completely exclude HIV infection, particularly during the window period.

3. Antiviral therapy may lead to false-negative results.

4. The test is validated only for urine; other body fluids may yield inaccurate results.

5. Interfering substances in the sample may affect result accuracy.