SARS-CoV-2 Antigen Swab Test Kit 1 Tests/Kit CE RTK Antigen Nasal Swab

Product Specification

SARS-CoV-2 Antigen Swab Test Kit 1 Tests/Kit CE for Nasal Swab

Materials Provided

Detection Limit

The limit of detection (LOD) for the SARS-CoV-2 Antigen Rapid Test is 4 x 102 TCID50/mL.

Interference

The following interfering substances have no impact on SARS-CoV-2 Antigen Rapid Test (Colloidal Gold).

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 contact with the buffer liquid.

2. Failure to follow the instructions may affect the test result. The final diagnosis should be confirmed by a physician.

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 line is visible in the test line region (T) and a colored line is visible in the control line region (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 guidelines and take a PCR confirmation test.
* Note: Line thickness is irrelevant; any reddish lines in the test line (T) 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 lines are visible in the area of the control line (C), but not at the test line (T), 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 contact 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 line is visible in the control line (C) or only one line is visible in the test line area (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 contact a physician or COVID-19 testing center.

Interpretation Of The Test Result

Check whether a line is visible at the control line (C). The color thickness of the control line (C) 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.

Disease severity classification

Mild: The clinical symptoms are mild, or even no obvious clinical symptoms, and no pneumonia is seen on imaging.

Ordinary type: with symptoms such as fever and respiratory tract, and pneumonia can be seen on imaging.

Heavy:

Adults meet any of the following:

· Respiratory distress, respiratory rate ≥ 30 breaths/min;

· In resting state, oxygen saturation ≤93%;

Arterial blood oxygen partial pressure (PaO₂)/inhaled oxygen concentration (FiO₂)≤300mmHg (1mmHg=0.133kPa), high altitude (over 1000 meters above sea level) area should be based on the following formula PaO₂/FiO₂ x [760/atmospheric pressure (mmHg) ].

In addition, if lung imaging shows that the lesions have progressed more than 50% within 24 to 48 hours, they are managed as severe.

Children meet any of the following:

· Persistent high fever for more than 3 days;

Shortness of breath (<2 months old, RR≥60 times/min; 2~12 months old, RR≥50 times/min; 1~5 years old, RR≥40 times/min; >5 years old, RR≥30 times/min /min), excluding the effects of fever and crying;

· Oxygen saturation ≤93% in resting state;

· Assisted breathing (groaning, alar flaring, three concave signs), cyanosis, intermittent apnea; drowsiness, convulsions;

· Rejection or feeding difficulties, with dehydration.

Critical:

One of the following conditions:

Respiratory failure occurs and requires mechanically assisted exhalation;

· Shock occurs;

· Combined with other organ failure requiring ICU monitoring and treatment.

Severe/critical high-risk groups

Older people over 60 years old; patients with underlying diseases; immunodeficiency; obesity (body mass index ≥ 30); women in late pregnancy and perinatal period; heavy smokers.

Q1: When will it be shipped?
A1: We will ship the goods for you as soon as possible within 7 working days after receiving the payment. (In the event of the epidemic and other external factors, there may be delays in shipping)

Q2: Does it support OEM/ODM?
A2: It can be supported, but the specific quantity needs to be more than 100,000 pieces to facilitate customized products.

Q3: How is your factory doing in terms of quality control?
A3: We have ISO9001 and ISO13485 certified by the state. Our production process is in accordance with the standard process, which can ensure that the quality of the products is optimal.

Q4: How is after-sales service provided?
A4: We provide professional online technical after-sales service. We can provide you with one-on-one guidance in the form of video, phone calls, etc.

Q5: What is the payment method?
A5: We receive payment by T/T.

Q6: How to ship?
A6: By obtaining quotations from our many cooperative carriers, choose the best way to ship for you, or you can ship according to your requirements.