Basic Info.
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
White List CE Approved Singclean Antigen Test Kit with Individual Buffer AG Rapid Test Kit Nasopharyngeal Swab
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. 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.
