Singclean Self-Testing Nasal Multi-Specification Antigen Nasopharyngeal Swab Test (Colloidal Gold Method)

• Customization: Available
• Type: IVD Reagent
• Material: Plastic
• 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&Box
• Specification: 1 test kit & 20 tests kit & 50 tests kit
• Trademark: Singclean or Customized brand
• Origin: China
• HS Code: 3002150090
• Production Capacity: 1000000PC/Week

Product Description

Singclean Antigen Test Kit
Intended Use
C-19 Test Kit(Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to c-19 in human nasopharyngeal. This test provides only a preliminary test result. Therefore, any reactive specimen with the C-19 Test Kit(Colloidal Gold Method) must be confimed with alternative testing method(s)and clinical findings.

Main Symptoms of C-19

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
•For healthcare workers use only

Comparison Among Different Testing Methods for C-19
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.

Product Information

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

Clinical Data
Packing
Test Procedures

Result Interpretation
Positive:
If 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:
If 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:
If control line (C) doesn't appear after performing the test, the result is considered invalid. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the failure of control line. Review the procedure and repeat the test with a new test kit.

Limitations
1. Use fresh samples whenever possible.
2. Positive results do 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 nasal cavity of the patient.
4. Negative results do 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. For a more accurate test result, repeat the tests or confirmed with other testing methods and clinical findings is recommended.

Warnings
1. This test is not for at home testing, and should only be operated by healthcare workers.
2. 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.