CE Approved Singclean Wholesale Rapid Antigen Test for Infectious Disease

• Type: IVD Reagent
• Use: Detection of Igg and Igm
• Speciems: Human Saliva
• Feature 1: Fast Results in 2-15 Minutes
• Feature 2: One Step Disinfection Tablets and Lancets
• Feature 3: High Sensitivity and Specificity
• Transport Package: Carton or Customized Package
• Specification: 1 test/box; 20 test/box; 50 test/box
• Trademark: Singclean
• Origin: China
• HS Code: 3002100090
• Production Capacity: 50000/Day

Product Description

Singclean Saliva Antigen rapid diagnostic test Antigen Test Kit


Introduction

Singclean C-19 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. Therefore, any reactive specimen with the C-19 Antigen Test kit (Colloidal Gold)
must be confirmed with alternative testing method (s) and clinical findings.

Main Symptoms of C-19



Features
•Quick: Results ready in 15 minutes, help with the global shortage of swabs and PPE
•Accurate: With a high level of accuracy that's comparable to nasopharyngeal swab testing
•Non-invasive: More comfortable than C-19 nasopharyngeal swab
•Safe: Will not require health care workers to be put at risk. Sampling can be done by patients
•Affordable: No need for instrument

Comparison Among Different Testing Methods for C-19
Clinical Data
A total of 397 samples were tested in this study
Antigen Test Kit vs PCR

Product Information

Product Name	Singclean C-19 Antigen Test Kit
Sample Type	Saliva Swab
Test Principle	Colloidal Gold Method
Sample Volume	3 Drops of Extracted Solution (100μl)
Qualitative/Quantitative	Qualitative
Test Time	15 mins
Operation Temperature	15-30°C
Storage Temperature	4-30°C
Shelf Life (Unopened)	24 months

Packing
Test Procedures

Storage and Stability

The kit can be stored at room temperature or refrigerated (4-30°C).
The test device is stable through the expiration date printed on the sealed pouch.
The test device must remain in the sealed pouch until use.
DO NOT FREEZE.
Do not use beyond the expiration date.
After opening the sealed pouch, use the test as soon as possible within 60 minutes

Result Interpretation

Positive:
lf both control line (C) and test line (T) appear, the result indicates the presence of C-19 antigen in the
specimen. The result is C-19 positive.
Negative:
lf only control line (C) appears, the result indicates that no C-19 antigens are detected in the specimen.
The result is C-19 negative.
Invalid:
Control line (C) fails to appear. Insufficient specimen volume or incorrect procedural techniques are the
most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette.

Limitations
1. Use fresh samples whenever possible.
2. A positive result does not rule out bacterial infection or co-infection with other viruses.
3. A negative result can occur if the quantity of the C-19 antigen present in the specimen is below the
detection limits of the assay, or failed to collect the C-19 antigen in the saliva of the patient.
4. A Negative result does not rule out infection with C-19 and should not be used as the final or sole
basis for treatment or patient management decisions. Negative results should be considered in the context
of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with
C-19.

Warnings
Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet.
Inadequate or inappropriate sample collection, storage, and transport may cause false test results.