Our COVID-19 Test Kit Is US FDA EUA Permitted

In light of the increasing numbers of COVID-19 cases throughout the United States and the world, the urgent need to expand the nation’s capacity for COVID-19 testing in clinical diagnostics during the public health emergency, FDA does not intend to object to a commercial company’s development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users.

 
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True-POC™ SARS-CoV-2 IgM/IgG Rapid Test Kit

 

Product Code:      BLI-1210

Pack Size:           20s/Pack
                         50s/Pack

 

Each Box Contains (20s/pack):

20x Individual sealed pouches (1x Test cassette) 

20x disposable pipettes,

20x Alcohol Pads, Pricks, Sample diluents 

and instructions for use (IFU).
 

Price:                  Inquiry

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Descriptions:
This COVID-19 Rapid Test Kit is suitable for the qualitative detection of SARS-CoV-2 IgM/IgG antibodies in human serum, plasma, or whole blood. Common signs of infection with SARS-CoV-2 include respiratory symptoms, fever, cough, shortness of breath, and dyspnea. In more severe cases, infection can cause pneumonia, severe acute respiratory syndrome, kidney failure, and even death. SARS-CoV-2 can be excreted through respiratory secretions or transmitted through oral fluids, sneezing, physical contact, and through air droplets.

The COVID-19 IgM/IgG antibody rapid test is a fast and effective method for screening IgM and IgG antibodies against SARS-CoV-2. This test can also suggest information on the stage of infection.

Both Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies are produced during the primary immune response. As the body’s largest antibody, IgM is the first antibody to appear in response to an initial exposure to antigens. IgM provides the first line of defence during viral infections, followed by the generation of adaptive, high affinity Immunoglobulin G (IgG) responses for long-term immunity and immunological memory. IgG is usually detectable about 7 days after the IgM appears.



Features:

  • IgG/IgM sensitivity: 93.3%, specificity: 96.6%. accuracy: 95.2%

  • Overall positive agreement rate of 99.1%, negative agreement rate of 97.0%.

  • Sample Volume: 10µL fingertip blood and whole blood sample, or 5µL serum and plasma

  • Detection Method: Colloidal Gold

  • Detection Time: 5 – 10 minutes

  • Suitable for Point of Care Testing, no need for extra equipment

  • FDA EUA permitted; CE Certified


Interpretation of Test Results

  • IgG and IgM POSITIVE (Left): Both the test lines and the quality control line are colored in the COVID-19 IgM/IgG Antibody Test Cassette.

  • IgG POSITIVE (middle): Two lines appear on the COVID-19 IgM/IgG Antibody Test Cassette. One coloured line appears in the control line region, and another coloured line appears in the IgG test line region. The result is positive for SARS-CoV-2 specific-IgG antibodies.

  • IgM POSITIVE (right): Two lines appear on the COVID-19 IgM/IgG Antibody Test Cassette. One coloured line appears in the control line region, and another coloured line appears in the IgM test line region. The result is positive for SARS-CoV-2 specific-IgM antibodies.

  • NEGATIVE: One coloured line appears in the control region. No apparent coloured line appears in the IgG or IgM test region.

  • INVALID: Control line fails to appear. Insufficient sample 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 cassette. If the problem persists, discontinue using the COVID-19 rapid test kit immediately and contact your local distributor.

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US FDA Guidance On COVID-19 Testing

“In light of the increasing numbers of COVID-19 cases throughout the United States and the world, the urgent need to expand the nation’s capacity for COVID-19 testing in clinical diagnostics during the public health emergency, FDA does not intend to object to a commercial manufacturer’s development and distribution of SARS-CoV-2 test kits for specimen testing for a reasonable period of time after the manufacturer’s validation of the test and while the manufacturer is preparing its EUA request where the manufacturer provides instructions for use of the test and posts data about the test’s performance characteristics on the manufacturer’s website. Transparency can help mitigate potential adverse impacts from a poorly designed test by facilitating better informed decisions by potential purchasers and users.

 

FDA believes that 15 business days is a reasonable period of time to prepare an EUA submission for a test whose performance characteristics have already been validated. Soon after receiving the EUA request, FDA will perform a preliminary review to identify if there are any problems with the performance data. If a problem is identified, FDA intends to work with the manufacturer to address the problem (e.g., through labeling or bench testing). If the problem is significant and cannot be addressed in a timely manner, and the manufacturer has already distributed the device, FDA would expect the manufacturer to suspend distribution and conduct a recall of the test.”

Criteria to Guide Evaluation and Laboratory Testing for COVID-19 (CDC)

Limited information is available to characterize the spectrum of clinical illness associated with coronavirus disease 2019 (COVID-19). No vaccine or specific treatment for COVID-19 is available; care is supportive.

The CDC clinical criteria for considering testing for COVID-19 have been developed based on what is known about COVID-19 and are subject to change as additional information becomes available.

Criteria to Guide Evaluation and Laboratory Testing for COVID-19

Clinicians considering testing of persons with possible COVID-19 should continue to work with their local and state health departments to coordinate testing through public health laboratories, or use COVID-19 diagnostic testing, authorized by the Food and Drug Administration under an Emergency Use Authorization (EUA) through clinical laboratories.  Increasing testing capacity will allow clinicians to consider COVID-19 testing for a wider group of symptomatic patients.

Clinicians should use their judgment to determine if a patient has signs and symptoms compatible with COVID-19 and whether the patient should be tested. Most patients with confirmed COVID-19 have developed fever and/or symptoms of acute respiratory illness (e.g., cough, difficulty breathing).

Priorities for testing include:

Other considerations that may guide testing are epidemiologic factors such as the occurrence of local community transmission of COVID-19 infections in a jurisdiction. Clinicians are strongly encouraged to test for other causes of respiratory illness.