Basic Info.
Model NO.
Saliva Antigen Test
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 2019 Novel 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.
