CE BfArm COVID-19 Test Kit Immunochromatography Test Method

NCoV Rapid Ag Test Kit Immunochromatography Test Method

Intended Use

This product is used for lateral flow immunoassays to qualitatively detect nasopharyngeal and oropharyngeal swabs in patients with suspected infection

Sample Requirements

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[Sample Requirements]
It is recommended to use polyester sponge samples with PP (polypropylene) rods for sterile sample collection.
(1) Oropharyngeal specimen collection method: the collection head is slightly tilted, and the two sides of the pharyngeal tonsils are exposed in the mouth. Wipe the pharyngeal tonsils at least three times along the base of the tongue, then wipe the posterior pharynx up and down with a cotton swab at least three times.
(2) Method for collecting nasopharyngeal specimens: The sampler gently holds the recipient's head with one hand and the swab with the other hand. Insert the swab into the nostril, slowly along the bottom of the lower nasal passage. Arc shape, do not use too much force, so as not to bleed from trauma. When the tip of the swab reaches the posterior wall of the nasopharyngeal cavity, gently rotate once (in the case of reflex cough) and then slowly remove the swab.
(3) Sample handling: The collected samples should be treated as soon as possible with the sample buffer provided by the kit (if not immediately processed, the samples should be stored in dry, sterilized and sealed plastic tubes) and stored at 2 °C ~ 8 °C, not more than 24 hours -70 °C long-term storage, but should avoid repeated freeze-thaw.

Test Method

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All reagents are returned to room temperature prior to testing. The test should be performed at room temperature.
I. Sample extraction (see Figure 1)
Add 400 L (~10 drops) of sample buffer vertically to the sample extraction tube, then insert the sample into the tube and spin about 10 times against the inner wall to make the sample in solution as soluble as possible.
2. Sample along the inner wall of the extraction tube to retain as much liquid in the sample as possible inside the tube, then remove and discard.
3. Cover the dropper.

Ii Test Procedure (see Figure 2)
1. Remove the test card from the sealed bag.
2. Add 2 drops (~80 L) of treated sample extract to the sample well of the test card and start the timer.
3. Read the results after placing the test card at room temperature for 15 min. Results are invalid after 20 minutes.

Interpretation of test results

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Schematic diagram of test card result judgment:
Invalid (1) Result: The quality control line (C line) has no reaction line, the detection is invalid, and the detection is repeated.
(2) Negative result: red ribbon, quality control line (C line) is colored.
(3) Positive result: two red bands, the detection line (T line) and the quality control line (C line) are colored.

Company profile

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Zhongxiu Qualifications

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DOC

Zhongxiu Science And Technology Co.,Ltd., founded in 2016, is located in Dingluan Industrial Zone, Changyuan City, Henan Province. The company covers an area of about 100 acres and the initial investment is about 200 million yuan. The company has a scientific and complete management system, a purification workshop of national standards, and a fully functional inspection center. On this basis, the company will continue to invest in research and development, accumulate technical strength, update manufacturing equipment, improve production technology, improve inspection technology, improve product quality, and provide customers with safe and effective in vitro diagnostic products.

Zhongxiu Science And Technology Co., Ltd. is a high-tech enterprise engaged in the research and development, production and operation of in vitro diagnostic products. The in vitro diagnostic products developed by the company cover POCT series, immune series, microbial series and other reagents and supporting instruments.

The company has always adhered to the core concept of “fast and accurate, living up to life”, committed to providing society with excellent products and services, and contributing to the cause of human health.