Our COVID-19 Nucleic Acid Molecular Test Kit Is US FDA EUA Listed
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.
True-POC™ SARS-CoV-2 Antigen Rapid Test Kit
Product Code: BLI-1211
Pack Size: 20s/Box
Each Box Contains (20s/pack):
20x Individual sealed pouches (1x Test cassette)
20x Nasal swabs
20x Sample buffer solutions
and instructions for use (IFU).
This COVID-19 Antigen Rapid Test Kit is for point-of-use, suitable for the qualitative detection of SARS-CoV-2 antigen in human nasal or saliva samples. The COVID-19 Antigen rapid test is a fast and effective method for screening initial infection of SARS-CoV-2 virus antigen. This test can suggest information on the beginning stage of COVID-19 infection.
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.
Detection Method: Colloidal Gold
Detection Time: 5 – 10 minutes
Suitable for Point of Care Testing, no need for extra equipment
FDA EUA Pending; CE Certified
Interpretation of Test Results
NOTE: The test results should be read and interpreted at 10 minutes after the sample application and the reading and interpretation of the results should not exceed 15 minutes. The test results should not be interpreted using any instruments.
two distinct colored lines appear. One red-colored line next to “C” and one blue-colored line next to “T” indicate COVID-19 positive result.
NOTE: The color intensity in the test region will vary depending on the amount of SARS-CoV-2 nucleocapsid protein antigen present in the sample. Any faint colored line(s) in the test region(s) should be considered as positive.
One red-colored line only next to “C” indicates a negative result.
NOTE: Negative results should be treated as presumptive and conﬁrmation with a molecular assay, if necessary, for patient management, may be performed.
If the red-colored line in the control region “C” is not visible, the result is invalid. Re-run the test one time using the remaining specimen in the extraction vial if an invalid result is obtained during initial testing.
Serial Testing Results Reporting
For serial testing programs, additional conﬁrmatory testing with a molecular test for negative results may be necessary, if there is a high likelihood of COVID-19, such as, an individual with a close contact with COVID-19 or with suspected exposure to COVID-19 or in communities with high prevalence of infection. Additional conﬁrmatory testing with a molecular test for positive results may also be necessary, if there is a low likelihood of COVID-19, such as in individuals without known exposures to COVID-19 or residing in communities with low prevalence of infection.
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.