Singclean® COVID-19 Test Kit for Nasopharyngeal Swab Testing 20230518

Product catalog summary

Intended Use: The COVID-19 Test Kit by Hangzhou Singclean Medical Products Co., Ltd. is designed for the rapid, qualitative detection of antigens to the 2019 Novel Coronavirus in human nasopharyngeal samples. It is intended for use by healthcare professionals for early detection and massive scale testing.

Main Symptoms of COVID-19: Fever, fatigue, cough, and shortness of breath.

Features: The test kit provides results in 15 minutes, is easy to administer, and does not require special facilities, making it suitable for large-scale testing. It is affordable, portable, and does not require additional instruments.

Comparison with Other Testing Methods: The antigen test is less accurate than PCR tests but is faster and cheaper. It is suitable for early-stage infection detection and does not require complex facilities.

Storage and Stability: The kit can be stored at room temperature or refrigerated (4-30°C) and should not be frozen. It remains stable until the expiration date on the sealed pouch.

Product Information: The test uses a colloidal gold method and requires a nasopharyngeal swab. It has a shelf life of 24 months unopened and operates best at temperatures between 15-30°C.

Clinical Data: The test shows a sensitivity of 98.56%, specificity of 99.03%, and accuracy of 98.84% at a 95% confidence level.

Test Procedures: The procedure involves collecting a nasopharyngeal swab, extracting the antigen, and applying the solution to the test device. Results are read after 15 minutes.

Result Interpretation: A positive result shows both control and test lines, a negative result shows only the control line, and an invalid result shows no control line.

Limitations: Positive results do not rule out co-infections, and negative results should not be the sole basis for treatment decisions. Negative results should be confirmed with additional testing.

Warnings: The test is not for home use and should be conducted by healthcare professionals. Proper sample collection and adherence to procedures are crucial for accurate results.

Catalog excerpts

Singclean® COVID-19 Test Kit for Nasopharyngeal Swab Testing 20230518-1

COVID-19 Test Kit (Colloidal Gold Method) One Step Coronavirus Antigen Rapid Test Cassette (Na (Nasopharyngeal Swab) Nasopharyngeal Swab) b) Precise Rapid Sensitive For Massive Scale Testing Hangzhou Singclean Medical Products Co.,L

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Singclean® COVID-19 Test Kit for Nasopharyngeal Swab Testing 20230518-2

COVID-19 Test Kit (Colloidal Gold Method) Intended Use COVID-19 Test Kit(Colloidal Gold Method) is a solid phase immunochromatographic assay for the rapid, qualitative detection of antigen to 2019 Novel Coronavirus in human nasopharyngeal. This test provides only a preliminary test result. Therefore, any reactive specimen with the COVID-19 Test Kit(Colloidal Gold Method) must be confimed with alternative testing method(s)and clinical findings. Fever Fatigue Cough Shortness of Breath Features •Results ready in 15 minutes •Accurate diagnostic tool for active infection •Easy to administer and read...

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Singclean® COVID-19 Test Kit for Nasopharyngeal Swab Testing 20230518-3

COVID-19 Test Kit (Colloidal Gold Method) Comparison Among Different Testing Methods for COVID-19 PCR Nucleic Acid Test Antibody Test Antigen Test Clinical Value Diagnosis, gold standard Auxiliary diagnosis When to take the test Early stage of infection Late or recurrent stage of infection Early stage of infection No special facilities needed, easy for healthcare professionals to use No special facilities needed, easy for healthcare professionals to use Result time Facility requirement Sample requirement Storage Saliva, nasal, oral or anal swabs Cold chain High; false positive is unlikely, false...

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Singclean® COVID-19 Test Kit for Nasopharyngeal Swab Testing 20230518-4

COVID-19 Test Kit (Colloidal Gold Method) Product Information Product Name Test Type Antigen Test Test Principle Colloidal Gold Method Sample Type Nasopharyngeal Swab Sample Volume 3 Drops of Extracted Solution (about 100μl) Test Time Operation Temperature Storage Temperature Shelf Life (Unopened)

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Singclean® COVID-19 Test Kit for Nasopharyngeal Swab Testing 20230518-5

COVID-19 Test Kit (Colloidal Gold Method) 1 Instruction 1 Paper Workbench 20 Test Kits 20 tests/kit and Dropper Tips 20 Extraction Buffers 1 Instruction 1 Test Kit 1 Swab 1 test/kit Dropper Tip 1 Extraction Buffer 1. Insert a sterile swab into the nostril of the patient, reaching the surface of the posterior nasopharynx. 2. Swab over the surface of the posterior nasopharynx. 3. Withdraw the sterile swab from the nasal cavity. 4. Insert the swab into an extraction buffer tube pre-added with 6 drops of extraction buffer, rotate the swab about 10 times. while pressing the swab head against the tube...

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Singclean® COVID-19 Test Kit for Nasopharyngeal Swab Testing 20230518-6

COVID-19 Test Kit (Colloidal Gold Method) Positive: If both control line (C) and test line (T) appear, the result indicates the presence of COVID-19 (SARS-CoV-2) antigen in the specimen. The result is COVID-19 positive. Negative: If only control line (C) appears, the result indicates that no COVID-19 (SARS-CoV-2) antigens are detected in the specimen. The result is COVID-19 negative. Invalid: If control line (C) doesn’t appear after performing the test, the result is considered invalid. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for the failure...

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Singclean® COVID-19 Test Kit for Nasopharyngeal Swab Testing 20230518-7

Dedicated to Healthcare Improvement Hangzhou Singclean Medical Products Co.,Ltd. Add:No.125(E),10th Street, Hangzhou Qiantang New Area, Zhejiang. China P.C.:310018 Tel:+86-571-63431868 Fax:+86-571-63431886 E-mail: [email protected] Web:www.Singclean.net

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