FDA Home In Vitro Diagnostic 20min COVID 19 Test Kit

Where To Get Home Diagnostic COVID 19 Test Kit High Accurate Coronavirus Antigen Test By Throat Swab Or Nasal Swab

COVID-19 Antigen Rapid Test Cassette

For the qualitative detection of SARS-CoV-2 antigen in human throat swab or nasal swab

Main Features

☀ High Sensitivity, Some Products can reach 100%

☀ High Specificity, Some Products can reach 100%

☀ Reliable: High Accurate, Early Detection of The Presence Of Virus

☀ Simple: No complicated Instrument Required

☀ Convenient: Room Temperature Storage, patented Built-In Control line for easy operation with high accuracy

☀ Fast: Results in 5-30 minutes, strong positive results may be observed promptly within 3 minutes

☀ Certified by Authoritative Certification System and Standards

☀ Winner of "the National Rapid Diagnostic Kit for Clinical Performance Assessment"

Intended Use

COVID-19 Antigen Rapid Test Cassette is for in vitro qualitative detection of specific antigens to SARS-CoV-2 present in human throat or nasal cavity. It cannot be used as the basis for the diagnosis and exclusion of COVID-19.

This reagent is used to detect cases with suspected symptoms of COVID-19 within 7 days. If suspected symptoms are more than 7 days, it is recommended to test with COVID-19 antibodies or nucleic acid reagents.

Principle

This kit uses double antibody sandwich immunoassay to detect specific antigens to SARS-CoV-2 in human throat or nasal cavity. The membrane was precoated with SARS-CoV-2 specific antibody on the test zone and goat anti mouse IgG antibody on the control zone.

During the test, the specimen is allowed to react with SARS-CoV-2 specific antibody-colloidal gold particles conjugate, which was predried on the test. The conjugate binds to the SARS-CoV-2 forming an Antibody~Antigen complex.

Materials Required But Not Provided

☀ Timer or stopwatch

☀ Biohazard disposal container

☀ Disposable gloves

☀ Disposable sampling swab

Sample Collection

☀ Throat Swab Sample

Take a disposable sampling swab out, insert it into the throat of the patient. Use the swab to gently wipe the pharyngeal tonsils on both sides of the patient for at least 3 times, and then wipe them on the posterior pharyngeal wall for at least 3times. Withdraw the swab from the throat.

☀ Nasal Swab Sample

Take a disposable sampling swab out, insert it into the nostril of the patient. Carefully insert the swab into the nostril. Gently rotating, pushing the swab until meet resistance at the level of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall then remove it from the nostril.

Interpretation of Results

☀ Positive: One color line in the control zone (C) and one color line in the test zone (T). This indicates that the sample contains SARS-CoV-2 antigen.

☀ Negative: Only one color line in the control zone (C). This indicates that no SARS-CoV-2 antigen has been detected.

☀ Invalid: If no color line appears in the control zone (C), the test is invalid. Discard the test cassette and perform with new cassette.

Performance Characteristics

1. Negative reference sample coincidence rate: 10 negative enterprise reference samples were tested and the

results were all negative.

2. Positive reference sample coincidence rate: 5 antigen positive enterprise reference samples were tested and the

results were all positive.

3. Minimum detectability:

3.1 3 limited detection of enterprise reference samples were used for testing, repeated 3 times, L1 should be negative, L2 and L3 should be positive.

3.2 The minimum detectability of this product for the SARS-CoV-2 virus strain is no more than 1.25×103.2TCID₅₀/ml.

4. Intra-lot repeatability: Parallel determination of enterprise repeatable reference samples, each repeated 10 times,

R1 should be negative, R2 and R3 should be positive.

5. Inter-lot repeatability: Parallel determination of enterprise repeatable reference samples with 3 batches of reagents, each batch repeated 10 times. With 3 batches of reagents, R1 should be negative, R2 and R3 should be positive.

6. Interfering substances: α - interferon, zanamivir, ribavirin, ritonavir, pramivir, lopinavir, abidol, levofloxacin, azithromycin, ceftriaxone, meropenem, tobramycin have no effect on the test results of this product.

7. Cross reaction: There was no cross-reaction with potential cross-reactive substances.

Warning

For Medical Professional and In Vitro Diagnostic use ONLY

Read the package insert completely before use. It is very important that the correct procedure is followed. Fail to add the patient sample may lead to a false result.

Newscen Biopharm Co., Limited is a professional manufacturer of in vitro diagnostic products and related supporting apparatuses, which is jointly founded by Tianjin Pharmaceutical Group, Tianjin Zhongxin Pharmaceuticals Co., Ltd and oversea Chinese entrepreneurs.

Founded in 2003, the company is one national high tech corporation and Tianjin Grade A medical device manufacturer. Over the years, the company has been committed to the research, development, production and sales of in vitro diagnostic products and related supporting apparatuses, and also has provided OEM and ODM and technology transfer and cooperation as well as some other customer market based diversified services to customers at home and abroad.

NewScen is based on independent innovation and relies on the talent sharing at home and abroad, information interaction advantage, antibody preparation and new product R & D technology platform to develop and produce nine series about one hundred kinds of products including tests and instruments and put on the market in succession.

HIV (1 + 2) antibody rapid test Kit and other IVD (In Vitro Diagnostic) devices obtained National Patent and National Class of New Drug Certificate; HCV Antibody Rapid Test is the first double antigen sandwich test HCV patented product; NewScen’s quantitative test broke through the technical difficulty of the colloid gold quantitative detection, opening up a new situation for clinical application of Colloidal Gold test. Rapid immuno assay reader provides an open and common platform for qualitative and quantitative detection of the Colloidal Gold test.

The company has received CFDA medical device certificates of 32 products, 49 independent Intellectual Property Rights, FDA certificates of series of products and European CE certificates of 16 products. Production management is in strict accordance with the regulations of in vitro diagnostic product production as well as international quality management system (ISO 9001, ISO 13485) so as to ensure high product quality. Products are sold throughout the country and in North America, South America, Southeast Asia, Europe, the Middle East, Africa and other international markets.

Currently, the company integrated Colloidal Gold test, immunochromatographic interpretoscope and cloud technology and other technical advantages, and created management integrated POCT system, so as to achieve convenient, accurate and efficient onsite data collection and remote guidance or data sharing of the monitoring center and promote the development of modern testing technique and the improvement of diagnosis and treatment level.

NewScen has obtained the project support from Tianjin or the country for nine times in succession, has been identified as one Hightech Enterprise in Tianjin, has obtained the title of “Top 100 Enterprise in Tianjin” among Tianjin SMEs, and is the rapid diagnostic Hightech demonstration project base and National 863 Project undertaker awarded by the NDRC (National Development and Reform Commission).

Fecal Occult Blood, Serum Ferritin and Hepatitis C rapid test products were named Tianjin independent innovation products; brand “YBT”products have been awarded the title of “Chinese Women and Children Favorite Brand Product” by Chinese Women and Children Development Center; “YBT” trademark was named “Tianjin Famous Trademark”.

“Honesty, Verity, Authenticity, and Innovation", is our persistent commitment.

“Encouraging Our Employees Growing With Company” is the driving force beneath our surging growth.