SARS-CoV-2 Antigen Swab Test Kit 1 Tests/Kit CE for Nasal Swab Specificity 100%
Early Symptoms
New coronary pneumonia generally has no obvious precursors. In the early stage of the disease after infection with the COVID-19, some patients may not have any obvious symptoms. Most other patients often have fever, dry cough, and fatigue as the main manifestations, but in addition, due to individual differences , The patient may also have muscle pain, chest tightness, itchy throat, sore throat, nasal congestion, runny nose, diarrhea, abnormal taste and other symptoms. These symptoms lack specificity and can be seen in many diseases, not unique to the new crown. Therefore, it is actually difficult for patients to identify whether they are infected with the COVID-19 by their own symptoms. When the above-mentioned symptoms appear, and you believe that you may have been exposed to the COVID-19 or infected people in the past, you should go to a medical institution for relevant examinations as soon as possible to confirm the diagnosis.
Materials Provided
| Component | Description | Specification |
| 1 test/kit | ||
| Test cassette | Foil ouched test device containing one reactive strip. | 1 |
| Sterile swab | For sample collection and transfer. | 1 |
| Inside page | Instructions for use. | 1 |
| Extraction buffer | Dissolve the sample | 1 |
| The certificate of conformity | 1 | |
| Packages with holes | Be used as tube stand (optional). | 1 |
Detection Limit
The limit of detection (LOD) for the SARS-CoV-2 Antigen Rapid Test is 4 x 102 TCID50/mL.
| OD Concentration TCID50/mL | of Positive/ Total | %Detected | |
A viral sample inactivated by gamma irradiation | 4 x 102TCID50/mL | 20/20 | 100% |
Interference
The following interfering substances have no impact on SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).
| No. | Interfering Substance | Final Test Concentration |
| 1 | Mucin | 0.54% |
| 2 | Menthol | 1.4 mg/mL |
| 3 | Whole Blood | 5% |
| 4 | Triamcinolone acetonide | 1 ng/mL |
| 5 | Tobramycin | 5 μg/mL |
| 6 | Levofloxacin | 1.5 μg/mL |
| 7 | Mupirocin | 12 mg/mL |
| 8 | Oxymetazon> | 9%v/v |
| 9 | Nasal Spary | 16%v/v |
| 10 | Dexamethasone | 0.5 μg/mL |
Hook Effect
No high dose hook effect was observed when tested with up to a concentration of 1.3 x 106 TCID50/mL of heat inactivated SARS-CoV-2 virus.
Warnings And Important Information
1. The test is designed for external use outside human body only. Please do not ingest. Avoid skin and eye with the buffer liquid.
2. Failure to follow the instructions may affect the test result. The final diagnosis should be confirmed by a sician.
3. Keep it out of reach of children.
4. Persons with reduced vision or mobility should ask for assistance.
5. Do not use the test if test components are damaged.
6. Use only the materials supplied with this test. Do not reuse the test or test components.
7. The test should be performed immediately, latest one hour after opening the foil pouch (at 20-30°C, humidity<60%).
Positive Test Result
If a colored isible in the test on (T) and a colored isible in the control on (C), indicating positive test result. This means that SARS CoV-2 antigens are detectable in your nasal sample and indicates with high probability of COVID-19 infection.
Please stay home and call your doctor or local health department. Follow local self-isolation guide take a PCR confirmation test.* Note: kness is irrelevant; any reddish the test should be interpreted as a positive test result. Positive test results must be confirmed by molecular diagnostics such as PCR testing.
Negative test result
If only colored visible in the area of the control but not at the test the test result is negative. This suggests that the nasal samples were either absent or too little of the SARS-CoV-2 antigen and probably not infected with the SARS-CoV-2 virus.
Continue to follow applicable rules regarding with others and applicable protective measures. In case of suspicion, repeat the test using new test kit, as SARS-CoV-2 virus cannot be accurately detected at all stages of infection. A negative result does not rule out infection with SARS CoV-2 and should be confirmed by PCR testing if suspected.
INVALID TEST RESULT
If no isible in the control or only one isible in the test (T), indicating the test is not performed correctly and the result is invalid. It is important to follow the instructions for the test carefully. Please repeat the test with new sample and new test set.
If test results remain invalid, please a sician or COVID-19 testing center.
Interpretation Of The Test Result
Check whether a isible at the control The color thickness of the control is irrelevant. If it is not visible, the test was not performed correctly and a new test with a new test set must be performed.
Storage and disposal
Store at room temperature (2-30°C or 35.6-86 T).Shelf life 12 months (from production date to expiration date).Test cassettes must be stored in airtight foil pouches until use. Do not use after expiration date.Waste from used tests should be disposed of according to local regulations.
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