PRODUCT NAME

SARS-CoV-2 Colloidal Gold Antigen Test for Nasal Swab Antigen Test (Rapid Antigen Test / Colloidal Gold Lateral Flow Test / anterior nasal swab / Colloidal Gold / Rapid Test Antigen)

PACKING

1kit/box; 5kits/box; 25kits/box; 50kits/box

	Composition
	Materials Provided in Rapid Antigen Test - Rapid Antigen Test cassette individually foil-pouched with a desiccant per person - Extraction buffer, extraction tube with dropper tip - Rapid Test Antigen Sampling swab   Materials Required But Not Provided   in Rapid Antigen Test - Medical mask and medical latex glove - Timer

INTENDED USE

The product is a Colloidal Gold lateral flow immunoassay intended for the qualitative detection SARS-CoV-2 nucleocapsid Rapid Test Antigen in nasopharyngeal, oropharyngeal or anterior nasal swabsecretions. Colloidal Gold Lateral Flow Test can be used for the screening of early infected patients and asymptomatic patients. Rapid Antigen Test can be used as a supplementary test for COVID-19 diagnosis.

SUMMARY

The novel corona viruses belong to the β genus. COVID-19 is an acute respiratory infectious disease. People are generally susceptible. Currently, the patients infected by the novel corona virus are the main source of infection; asymptomatic infected people can also be an infectious source. Based on the current epidemiological investigation, the incubation period is 1 to 14 days, mostly 3 to 7 days. The main manifestations include fever, fatigue and dry cough. Nasal congestion, runny nose, sore throat, myalgia and diarrhea are found in a few cases.

PRINCIPLE

• The product is an immunoassay based on the principle of the double antibody - sandwich and colloidal gold technique and is designed to detect nucleocapsid Rapid Test Antigen from the SARS-CoV-2 in nasopharyngeal and oropharyngeal secretions.

• During Colloidal Gold Rapid Antigen Test, a specimen migrates upward by capillary action. The SARS-CoV-2 Rapid Test Antigen if present in the specimen will bind to the antibody conjugates . The immune complex is then captured on the membrane by thepre-coated SARS-Co-2 nucleocapsid protein monoclonal antibody, and a visible colored line will show up in the Colloidal Gold Rapid Antigen Test line region indicating a positive result. In the absence of SARS-CoV-2 Rapid Test Antigen, a colored line will not form in the Colloidal Gold Rapid Antigen test line region indicating a negative result.

• To serve as a procedural control,a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred.

STORAGE AND STABILITY

1. Store as packaged in the sealed pouch at temperature (4-30℃ or 40- 86F). The Lateral Flow Test kits stable within the expiration date printed on the labeling.

2. Once open the pouch, the Colloidal Gold Rapid Antigen Test should be used within one hour. Prolonged exposure to hot and humid environment will cause product deterioration.

3. The Lateral Flow Test kit is valid for 18 months. Do not use beyond the expiration date.

4. The LOT and the expiration date were printed on the labeling.

Colloidal Gold Rapid Antigen Test Procedure

Allow the Colloidal Gold Rapid Antigen Test, specimen, buffer and/or controls to reach room temperature (15-30°C or 59-86℉) prior to testing.

1.  Preparation：Open the cap ofextraction tube, transfer the extraction buffer into the extraction tube.

2. Sample Collection：Use the NP/OP swab provided in the Lateral Flow Test Lateral Flow Test kit to wipe the back wall of the nasopharyngeal cavity deep in the nasalcavity (NP swab), or swab overthe lateral and posterior walls of pharynx, as well as the intratonsillar cleft (OP swab).

3. Sample Extraction：Insert the swab into the tube, slowly rotate the swab for mixing of the sample and the extraction buffer. Pinch the tube when removing the swab, put the used swab into biohazard bag, and then close the extraction tube with dropper.

4. Assay procedure：Remove the Colloidal Gold Rapid Antigen Test Cassette from the foil pouch, place the cassette on a clean and level surface. Reverse the specimen extraction tube, holding the specimen extraction tube upright, transfer 3 drops (approximately 80pL) to the specimen well (S) of the rapid test antigen test cassette, then start the timer. Interpretation is available within 10-15 minutes. Wait for the colored line(s) to appear. Do not interpret the result after 20 minutes.

INTERPRETATION OF RESULTS

Positive(+): Two colored lines appear. One colored line should always appear in the control region (C) and another apparent colored line adjacent should be in the Colloidal Gold Rapid Antigen Test region (T).

*NOTE: The intensity of the color in the Colloidal Gold Rapid Antigen Test line region may vary depending on the concentration of SARS-CoV-2 Rapid Test Antigen present in the specimen. Therefore, any shade of color in the testline region should be considered positive.

NEGATIVE(-): One colored line appears in the control line region (C) in Lateral Flow Test Cassette. No line appears in the Colloidal Gold Rapid Antigen Test region (T).

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 Colloidal Gold Rapid Antigen Test Lateral Flow Test with a new Colloidal Gold Rapid Antigen Test. If the problem persists, discontinue using the Colloidal Gold Rapid Antigen Test Lateral Flow Test kit Lateral Flow Test Immediately and contact your local distributor.

Warnings and precautions

1. For in vitro diagnostic use only.

2. Please read all the information in this instructions for use before performing the Colloidal Gold Rapid Antigen Test.

3. Please make sure that a proper amount of sample is collecting for testing. Too much or too little sample may cause deviations in results.

4. If part of the Colloidal Gold Rapid Antigen Test paperin the strip isout of the rapid test antigen test window, do not use.  The test result is invalid and should replace with another new Lateral Flow Test kit. If the rapid test antigen test result is negative but clinical symptoms persist, further testing using otherclinicalmethods (PCR) is recommended.

5. Results from the Colloidal Gold Rapid Antigen Rapid Test

Rapid test antigen test should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status.

6. All specimens should be considered potentially hazardous, please handle all specimens as if they contain infectious agents. Observe established precautions against microbiological hazards through out all procedures and follow the standard procedures for proper disposal of specimens. Do not take any decision of medical relevance without first consulting your medical practitioner. 

FAQ

Q1: What's your advantage? Why we choose you?

A: We are professinal source manufacturer in China. We have 3000m2 100,000-level standardized purification workshop with strong manufacturing ability and we have high value with competitive price.

Q2: What ls your payment term?

A: Payment term ls T/T in advance.

Q3: Do you have any certificates?

A: We have passed ISO 13485 Quality Management System certification, and we have ave obtained CE certifications and all the certificates required for export and local import custom clearance.

Q4: Where is your main market located?

A: 60% in Europe, 30% in Middle East and 10% in South Africa

Q5: What's your lead time?

A: For mass production, we deliver by batches and first batch can be delivered within 10-15 days after payment.

Q6: Do you support OEM/ODM?

A: YES, we can prototype and customize the ideal product according to your specific application.

Q7: How is the product package

A: Every unit is individually packed, and store in box and carton, we can also pack 12-18 cartons in one palletes for stable transportation.