| Customization: | Available |
|---|---|
| Type: | IVD Reagent |
| Quality Guarantee Period: | Two Years |
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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
| Product Name | Singclean HIV Antibody Urine Test kit (Colloidal Gold Method) |
| Method of Detection | Colloidal Gold Method |
| Qualitative/Quantitative | Qualitative |
| Specimen | Urine |
| Required Volume of Specimen | 3 drops (approximately 100ul) |
| Packaging Specifications | Cassette: 1 test/box,10 tests/box, 20 tests/box, 50 tests/box. |
Storage Conditions and Validity Period
1. Store at 4~30ºC, avoid light and dry, valid for 24 months.
2. See the outer packaging for the production date and expiration date. Do not freeze or use after expiration date.
3. After opening the sealed pouch, use the test as soon as possible within 1 hour.
Testing Method
Allow the test box to equilibrate to room temperature prior to testing.
1. Remove the test card from the sealed foil bag and use it as soon as possible. After opening the sealed pouch, use the test
as soon as possible within 1 hour.
2. Place the test apparatus on a clean, level surface.
3. Aspirate the urine sample with the provided dropper, then add 3 drops (approximately 100ul) of urine sample to
the sample well. Start the timer.
4. Waiting for results. Results should be read after 15 minutes. The results after 20 minutes are not convincing.
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 amount
The minimum detection limit was 0.2NCU/ mL using a constant reference diluted by negative urine
2. The sensitivity
The positive detection rate was 100% for 200 hiv-1 antibody positive serum samples diluted 10-fold with normal urine, and 100% for 50 HIV-2 positive reference samples diluted 10-fold with normal urine.
3. Specificity
361 urine samples were negative, and the negative coincidence rate was 96.2%
4. Precision
Tested continuously for 20 days, the precision was consistent between batches and within batches, and the coincidence rate of repeated test was 100% for the same samples.
5. Cross reaction
Syphilis,hepatitis c, hepatitis B,CEA,Flu A , Flu B , HAMA , RF , ALT , COVLD-19,urine occult blood, total protein, urinary bilirubin no cross reaction in positive samples with the kit.
6. Interfering Material
MOP THC COC MET OPI BZO TCA OXY AMP MTD BAR MDMA no interference at 200mg/ml.
zidovudine Edurant nevirapine ritonavir famciclovir isoniazid no interference at 100mg/ml
7. HIV subtypes detected
It can detect HIV-1 type A, B, C, E, O . Also can detect HIV-2.
Limitations of the test method
1. This kit is a clinical auxiliary diagnostic product, which can rapidly detect human immunodeficiency virus type I (HIV-1) antibody
and type II (HIV-2) antibody in urine. The test results are for clinical reference only and cannot be used alone as the basis
for confirming or excluding cases. For the purpose of diagnosis, the test results should be used in conjunction with clinical examination, medical history and other examinations.
2. Due to the limitations of the method, a negative test result does not rule out the possibility of HIV infection in patients,
especially those infected in the window phase.
3. Samples undergoing antiviral infection treatment may have false negatives.
4. The test sample is urine, and other body fluids may be inaccurate .
5. The presence of interfering substances in the sample may lead to incorrect test results.
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