Best Diagnostic Novel Coronavirus Test Kits Wholesale - COVID-19 Testing Kits

# COVID-19 Coronavirus Test Kits-2019123101
Minimum Order 1 Pack (one set includes 25 Tests)
Best Diagnostic Novel Coronavirus Test Kits Wholesale - COVID-19 Testing Kits

GenSure Biotech Inc Diagnostic Novel Coronavirus Test Kits Portable Rapit COVID-19 Testing Kit for Coronavirus - Latex Assay Result in 5 Minutes

2019 Novel Coronavirus Dianostic Test kits - 2019-nCoV Test Kit for COVID-19

Portable COVID-19 Testing Resource Platform: Novel Coronavirus(Sars-CoV-2) IgM Antibody Rapid Test Kit (Latex Assay)

At present, Our Coronavirus Testing Kits the only product which is tested by latex test on the Chinese market . The raw material has higher sensitivity, stronger stability and more accurate test results;

Product Name

Common name: Novel Coronavirus(Sars-CoV-2) IgM Antibody Rapid Test Kit (Latex Assay)

Packing Specifications 

25 Tests / Box

Packing box specification:
17 * 14 * 6cm, the weight of the product is 0.25kg after being packed in boxes; 25 copies for each box; 
 
Packing case specification:
42.9 * 34.8 * 30.5cm, case weight: 1kg,
30 boxes for each case, 750 people, total weight of one box of product: 8.5Kg.
  • Authorised Representative: Domestic and Overseas
  • Rapid blood test for coronavirus - COVID-19 / 2019-nCoV
  • Identify COVID-19 infection before symptoms appear
  • Screen workforce and isolate carriers immediately
  • CE authorized from Netherlands and certified for professional use
  • Results in under 5 minutes
  • Each kit screens one person. Single use
  • Certification:  CE (CONFORMITE EUROPEENNE)  ( NO FDA yet, we can not ship to the US) only ship to European countries with CE )
  • Patent license: YES
  • Contents: 25T Cassettes With Pipettes; Instruction manual; Specimen Buffer
  • Novel Coronavirus Test Kits wholesale, GenSure Biotech company is the only manufacturer in the world with domestic and overseas authorized licenses. Current tests to diagnose coronavirus take up to 24 hours to confirm, Ours Testing kit is Rapid result with 5 minutes

Expected Usage 

This product is used for the qualitative detection of new coronavirus 2019-nCoV IgM antibodies in human serum, plasma or whole blood.

Coronaviruses are a large family of viruses that are known to cause colds and more serious diseases such as the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS). Coronaviruses are systematically classified as Coronaviridae (Coronaviridae). Coronaviruses are single-stranded RNA viruses with positive envelopes that infect only human, mouse, pig, cat, dog, and avian vertebrates. The Ninth International Committee on Classification of Virology divided the Coronaviridae into three genera, namely, alpha, beta, and gamma. Coronavirus is excreted through respiratory secretions, transmitted through oral fluid, sneeze, contact, and transmitted through air droplets.

The 2019 novel coronavirus (or '2019-nCoV', 'COVID-19', 'SARS-CoV-2') was discovered because of Wuhan virus pneumonia cases in 2019, and was named by the World Health Organization on January 12, 2020. The new coronavirus is a new coronavirus strain that has never been found in humans before.

Inspection Principle 

This product is composed of the novel coronavirus 2019-nCoV specific dominant epitope antigen fixed on a nitrocellulose membrane, a colored latex-labeled anti-human IgM antibody release pad and other reagents. The latex immunochromatographic technology was used to detect the new coronavirus 2019-nCoV antibody in human serum / plasma / whole blood using the principle of capture method.

During the test, a blood sample is added to the sample well of the kit. The sample is first mixed with the colored latex-labeled anti-human IgM on the release pad, and then chromatographed on a nitrocellulose membrane. If the sample contains new coronavirus 2019-nCoV antibodies, these antibodies will first bind to colored latex-labeled anti-human IgM, so that when the mixture is chromatographed on a nitrocellulose membrane, it will be immobilized with the new coronavirus 2019-nCoV antigen. The detection line (T line) was captured to form a colored latex-labeled anti-human IgM-antibody-antigen immune complex. Therefore, a red line appeared on the T line, which was a positive result. If no new coronavirus 2019-nCoV antibody is present in the blood of the subject, a red line will not be formed on the test line (T line), which is a negative result. The quality control line (C line) on the test card is coated with goat anti-mouse antibody. Under normal circumstances, a red line should appear on the quality control line(C line) during the test to prove that the test card is working properly.

Main Ingredients in the Novel Coronavirus Test Kit

  1. Novel Coronavirus 2019-nCoV IgM Detection test card
  2. one sample pipette per test;
  3. one bottle of sample dilution per box;
  4. Instruction manual: 1 copy.

Storage Conditions And Validity   

Store at 4-30℃, protected from light, valid for 12 months. Do not freeze.

Sample Requirements 

  1. The applicable sample type for this test kit is serum / plasma / whole blood.
  2. The whole blood is drawn according to the standard clinical laboratory method, and serum or plasma is separated, and hemolysis should be avoided as much as possible during processing.
  3. The samples should be tested as soon as possible after collection to avoid leaving them for a long time at room temperature. If serum or plasma samples cannot be detected immediately, they can be stored at 2-8℃。
  4. The sample must be returned to room temperature before testing.

Testing Method 

  1. Please read the instruction manual carefully before testing.
  2. Take out the test card, test sample and control, etc., and use it after returning to room temperature. When everything is ready, tear off the aluminum foil bag, take out the test card and place it on the water platform.
  3. Add sample:
    Whole blood sample: Add 2 drops of whole blood vertically to the sample well with the sample pipette, and then add 1-2 drops of sample diluent.
    Serum / plasma sample: Add 1 drop vertically to the sample well with the addition pipette, and then add 1-2 drops of sample dilution solution.
  4. Timing observation: judge the result 10 minutes after adding the sample, do not observe the result after 20 minutes.

Interpretation of test results                                                                      

  • Positive: A red line appears on the quality control line (C line) and the detection line (T line). It indicates that the new coronavirus 2019-nCoV/COVID-19 antibody is present in the sample.
  • Negative: Only the quality control line (C line) has a red line, and the detection line (T line) has no red line. It means that no new coronavirus 2019-nCoV/COVID-19 antibody in the sample or new coronavirus 2019-nCoV antibody level is below the detection level.
  • Invalid: No red line appears on the quality control line (C line), indicating failure. It may be due to improper operation or test card is invalid and should be retried.

Limitations Of Detection Methods                                                                
The test results of this product are only used as a supplement for doctors or other diagnosis.
Product Performance Index                                                                     

  1. Detection limit: Tested with the detection limit reference, the results are all positive.
  2. Precision: Test the same sample 5 times, the test results are consistent and the color of line is uniform.
  3. Positive compliance rate and negative compliance rate:
    Positive compliance rate: Test 3 positive reference samples, the positive compliance rate was 100%;
    Negative compliance rate: Test 10 negative reference materials, the negative compliance rate was 100%.
  4. Interference test:
    When the content of bilirubin in the sample to be tested is less than 200mg / L, there is no interference with the test results;When the cholesterol in the sample to be tested is less than 2500mg / L, there is no interference with the test results; when the hemoglobin in the sample is less than 2500mg / L, it does not interfere with the test results; Rheumatoid factor (RF) positive, hepatitis B, hepatitis C, and hepatitis E samples did not interfere with the test results.

Precautions                                                                                   

  1. This product is for in vitro testing only.
  2. If the sample is suspected to be contaminated, re-sampling should be performed.
  3. Do not use expired kits.
  4. All samples shall be treated as infectious materials during the test.

Basic Information                                                                               
Registrant / Manufacturer: GenSure Biotech Inc.,
Address: B1-78, Rizhongtian Science and Technology Park, No.585 Tianshan Street, Shijiazhuang High-tech Zone, Hebei,China.

Utill now Chinese goverment has selected 9 products from 8 companies from the 300 companies who declared, and submitted the 9 products to the National Medical Products Administration of China for emergency approval.
This product is one of the 9 products listed above that have been approved, it was jointly developed by GenSure Biotech Inc., PLA General Hospital (301 Hospital), Tongji Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology, Tianyou Hospital Affiliated to Wuhan University of Science and Technology, Second Hospital of Hebei Medical University and Beijing Jinwufu Biological Engineering Technology Co., Ltd. 

Below is the video to show you how to use Novel Coronavirus COVID-19 IgM Antibody Rapid Testing Kit: 

Diagnostic Test Kit for Novel Coronavirus 2019-nCov IgM testing result video


More information about Coronavirus Testing Kit from Gensure Biotech Inc. Company

  
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