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.

The Rapid Antigen Test Kit is a lateral flow test (immunoassay) intended for the qualitative detection SARS-CoV-2 nucleocapsid antigens in Nasopharyngeal Swab Antigen Test and oropharyngeal Antigen Swab Test. It can be used for the screening of early infected patients and asymptomatic patients. The Antigen Rapid Test Kit can be used as a supplementary test for COVID-19 diagnosis.

• Lateral flow test.

• Non-inavise.

• Rapid Results interpretation time 

• Detection for SARS-Cov-2 nucleo capsid protein antigen
• Intended at point of care by profes sional healcare provider

· Nasopahryngeal swab specimens
· Oropahryngeal swab specimens
· Anterior nasal swab specimens
· Oralswab/Buccal swab specimens
• Time: Read result in 15 min 

• Sensitivity: 89.6% 

• Specificity: 100%

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

Antigen Swab Test Type: Nasopharyngeal Swab Antigen Test / Oropharyngeal Swab Antigen Test/ Anterior Nasal Rapid Antigen Swab Test /Anterior Oral Rapid Antigen Swab Test

Comparison of test method

Rapid Antigen Test Process

Allow the 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 of extraction tube, transfer the extraction buffer into the extraction tube.

2. Sample Collection：Use the NP/OP swab provided in the 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 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 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 test region (T).

*NOTE:The intensity of the color in the test line region may vary depending on the concentration of SARS-CoV-2 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). No line appears in the 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 test with a new test. If the problem persists, discontinue using the test kit Immediately and contact your local distributor.

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.