Singclean Quick Profile Multi-Specification Nasal Antigen Test Device (Colloidal Gold Method) with CE1434

• Customization: Available
• Type: Ivd Reagent
• Material: Plastic
• Quality Guarante: 2 Years
• Sensitivity: 92.15%-99.05%
• Specificity: 97.47%-99.61%
• Accuracy: 97.19%-99.33%
• Lead Time: 3-8 Days After Payment
• Certification: CE, Doc, ISO, Who(in Application)
• When to Test: Early Stage of Infection
• Symptoms: Fever, Cough, Fatigue, Shortness of Breath
• Test Time: 10-15 Minutes
• Sample: Nasal Swab
• Storage: 4-30 Degree
• Main Market: Europe
• Transport Package: Carton or Customized Package
• Specification: 20 tests/box, 1 test/box
• Trademark: Singclean or Customized brand
• Origin: China
• HS Code: 3002150050
• Production Capacity: 1 Million PCS/Week

Product Description

Self Testing Singclean Nasal Antigen Test Kit CE Approved

Intended Use

Singclean C-19 Antigen Test kit (Saliva Swab) is a solid phase immunochromatographic assay for the
rapid, qualitative detection of antigen to Novel C-19 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
1.Results ready in 15minutes
2.Accurate diagnostic tool for active infection
3.Easy to administer and read results
4.Affordable, no need for instrument, highly portable
5.Enable testing on a massive scale
6.For healthcare workers use only

Comparison Among Different Testing Methods for C-19
Product Information
 

Product Name	Singclean C-19 Antigen Test Kit
Sample Type	Nasal 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

PERFORMANCE CHARACTERISTICS

Clinical Sensitivity, Specificity and Accuracy
The results of the C-19 Test Kit(Colloidal Gold Method) were compared to results of RT-PCR assays for c-19in nasal swab specimens. A total of 499 nasal cavity specimens were tested in this study. The C-19 clinical specimens contain specimens from individuals with symptoms within 7 days. The results of test reagent and control reagent both were 350 negative specimens and 149 positive specimens. The sensitivity and specificity calculated were valid in this study. C19 Test Kit vs PCR

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

Test Procedures
Result Interpretation

Negative:
If only the C band is present, the absence of any burgundy color in the T band indicates that no
C-19 antigen is detected in the specimen. The result is negative.
If the test result is negative:
Continue to follow all applicable rules regarding contact with others and protective measures.
Even if the test is negative, an infection may be present. In case of suspicion, repeat the test after 1 - 2 days, because the Coronavirus cannot be accurately detected at all stages of infection.

C-19 Positive:
If the C and T band is present, the test indicates for the presence of C-19 antigen
in the specimen. The result is C-19 positive.
There is currently a suspicion of a C-19 infection.
Contact physician/family physician or local health department immediately.
Follow local guidelines for self-isolation.
Have a PCR confirmatory test performed.

Invalid:
Control line 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. If the problem persists, discontinue using the test kit immediately and contact your local distributor.
In case of an invalid test result:
Possibly advance warning due to incorrect test performance.
Repeat the test.
If test results are still invalid, contact a physician or a C-19- Test Center.


Limitations  
1. Use fresh samples whenever possible.
2. Optimal assay performance requires strict adherence to the assay procedure described in this insert sheet. Deviations may lead to aberrant results.
3. A negative result for an individual subject indicates absence of detectable C-19 antigen. However, a negative test result does not preclude the possibility of exposure to or infection with C-19.
4. 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 nasal cavity of the patient.
5. The test kit provides a presumptive diagnosis. A conformed diagnosis should only be made by a physician after all clinical and laboratory findings have been evaluated.
6. Only use for in vitro diagnostic, and cannot reused.
7. The antigen extract buffer is used to extract specimens, and shall not be used internal or external by humans or animals. Swallowing will cause a serious accident. If happens, please seek medical attention immediately.
The antigen extract is irritating to eyes and skin, if splashed into eyes accidentally, please rinse with water soon. If necessary, consult a doctor and maintain ventilation during the procedure.

Warnings And Precautions
1. For non-professional self-testing use. Do not use after expiration date.
2. This package insert must be read completely before performing the test. Failure to follow the insert gives
inaccurate test results.
3. Do not use it if the tube/pouch is damaged or broken.
4. Test is for single use only. Do not re-use under any circumstances.
5. Humidity and temperature can adversely affect results.