Singclean Wholesale One Step Lab Rapid Diagnostic Ivd Medical Instrument Urine Reagent Human Immunodeficiency Virus Test Kits for HIV Screening

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Product Description

Basic Info.
Quality Guarantee2 Years
Sensitivity92.15%-99.05%
Specificity97.47%-99.61%
Accuracy97.19%-99.33%
Lead Time3-8 Days
CertificationCE, Doc, ISO
When to TestEarly Stage of Infection
Test Time10-15 Minutes
SampleNasal Swab
Storage4-30 Degree
Main MarketEurope
Specification20 tests/box, 1 test/box
Antigen Test Kit Banner
Product Description

Self Testing Nasal Antigen Test Kit CE Approved

Divider
Intended Use

The Antigen Test kit (Saliva Swab) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to C-19 virus in human saliva. This test provides only a preliminary test result. Any reactive specimen must be confirmed with alternative testing methods and clinical findings.

Main Symptoms of C-19
Symptoms
Key Features
Results ready in 15 minutes
Accurate diagnostic tool for active infection
Easy to administer and read results
Affordable, no need for instrument, highly portable
Enable testing on a massive scale
Designed for efficiency and reliability
Comparison & Information
Comparison Methods
Product NameAntigen Test Kit
Sample TypeNasal Swab
Test PrincipleColloidal Gold Method
Sample Volume3 Drops of Extracted Solution (100μl)
Test Time15 mins
Operation Temp15-30°C
Storage Temp4-30°C
Shelf Life24 months
Performance Characteristics

A total of 499 nasal cavity specimens were tested. The clinical specimens contain samples from individuals with symptoms within 7 days. The sensitivity and specificity calculated were validated against RT-PCR assays.

PCR Comparison
Test Procedures & Result Interpretation
Procedures Result Interpretation
Negative: Only C band is present. No C-19 antigen detected.
Positive: Both C and T bands are present. Indicates presence of C-19 antigen.
Invalid: Control line (C) fails to appear. Repeat the test with a new cassette.
Limitations & Precautions

1. Use fresh samples whenever possible.
2. Strict adherence to procedure is required for optimal performance.
3. A negative result does not totally preclude infection possibility.
4. The extraction buffer should not be ingested; seek medical attention if swallowed.
5. For single use only. Do not reuse under any circumstances.

Manual 1 Manual 2
Frequently Asked Questions (FAQ)
Q1: How long does it take to get the test results? A1: The results are ready in approximately 10 to 15 minutes. Do not interpret results after 20 minutes.
Q2: What is the required storage temperature for the kit? A2: The kit should be stored at room temperature or refrigerated between 4-30°C. Do not freeze.
Q3: Can this test kit be reused? A3: No, the test device and all components are for single use only.
Q4: What should I do if the result is positive? A4: A positive result indicates the presence of antigens. You should contact a physician immediately and follow local self-isolation guidelines.
Q5: Is the test suitable for home self-testing? A5: Yes, this kit is designed for non-professional self-testing use with easy-to-read results.
Q6: What sample types can be used with this kit? A6: This specific kit is designed for use with Nasal Swab or Saliva Swab samples as indicated in the product specifications.

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