Singclean Wholesale Quick Rapid Diagnostic Self-Test Home Ivd Medical Products Urine Reagent Human Immunodeficiency Virus Test Kits

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Product Description

HIV Antibody Urine Assay Kit

Basic Info.

Logo Printing OEM Brand
Advantage on-Site Drug Testing
Feature One-Step Operation
Transport Package Carton or Box
Origin China
HS Code 3302100090
Production Capacity 50000/Day

Product Description

HIV-1/2 Antibody Urine Assay Kit (Colloidal Gold)
Product Divider
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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 HIV Antibody Urine Test kit (Colloidal Gold Method)
Method of Detection Colloidal Gold Method
Qualitative/Quantitative Qualitative
Specimen Urine
Required Volume 3 drops (approximately 100ul)
Packaging Specs Cassette: 1 test/box, 10 tests/box, 20 tests/box, 50 tests/box.

Storage Conditions and Validity

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  • Store at 4~30ºC, avoid light and dry, valid for 24 months.
  • See the outer packaging for the production date and expiration date. Do not freeze or use after expiration date.
  • 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 within 1 hour.
2
Place the test apparatus on a clean, level surface.
3
Aspirate the urine sample with the provided dropper, add 3 drops to the sample well. Start the timer.
4
Read results at 15 minutes. Results after 20 minutes are not convincing.

Explanation of Test Results

Test Result Guide

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.

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.

Invalid: Control lines do not appear. Regardless of the T line, it is an invalid result.

Performance

Detection Limit: 0.2NCU/ mL
Sensitivity: 100% for HIV-1 and HIV-2
Specificity: 96.2% negative coincidence rate
Precision: 100% coincidence rate in repeated tests

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

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

Limitations

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  1. Clinical auxiliary diagnostic only. Must be used with medical history and clinical exams.
  2. Negative results do not rule out infection, especially in the window phase.
  3. Antiviral treatment may cause false negatives.
  4. Tested sample must be urine.
  5. Interfering substances may lead to incorrect results.

Frequently Asked Questions (FAQ)

Q1: How long should I wait to read the test results? The results should be read after 15 minutes. Results read after 20 minutes are not considered reliable.
Q2: Can I use this test for home self-testing? Yes, this product is designed for qualitative determination and is suitable for consumer self-testing as an auxiliary diagnosis tool.
Q3: What type of sample is required for this kit? This test kit requires only 3 drops (approximately 100ul) of human urine sample.
Q4: Does a negative result completely rule out HIV infection? Not necessarily. A negative result does not rule out the possibility of infection, especially if the individual is in the "window phase" of infection.
Q5: What are the storage requirements for the test kit? The kit should be stored at 4~30ºC in a dry, light-protected environment. It has a validity period of 24 months.
Q6: What should I do if the control line (C) does not appear? If the C line does not appear, the test is invalid regardless of whether a T line is visible. You should repeat the test with a new kit.

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