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.
COVID-19 RT-PCR Test Kit (Nucleic Acid Molecular Test)
Product Code: GFYV103-001
Components: G1C Primer mix
G1C Positive control
G1 2X RT-PCR Premix
G1 Sterilized ddH2O
G1I Internal control
Quantity: 100 reactions/Kit
The GeneOne COVID-19 RT-PCR Test Kit is a fast nucleic acid conformation test, highly sensitive diagnostic solution that contains the assays and controls needed for the real-time PCR detection of RNA from the SARS-CoV-2 virus.
The GeneOne COVID-19 RT-PCR Test Kit can be used by clinical and public health laboratories to quickly evaluate up to 100 patient specimens in under 1 hour. The kit is permitted for use with RNA extracted from nasopharyngeal swabs, nasopharyngeal aspirate (nasal aspirate), and bronchoalveolar lavage (BAL) from patients at risk of exposure to the SARS-CoV-2 virus or with signs and symptoms of COVID-19 (see product label for Intended Use Statement and product information). The GeneOne COVID-19 Test Kit is a single, high-throughput (100 reactions) kit and is recommended for use with either the ABI 7500 Fast Dx Real-Time PCR System or other Real-Time PCR System (i.e. Biorad, Qiagen and etc...).
• A complete workflow for genetic analysis using real-time PCR to diagnostic report generation in under 45 minutes
• Targeted specificity to 100% of currently available complete genomes for SARS-CoV-2
• Assay targets spike (S) protein and nucleocapsid (N) protein regions having higher specificity and exhibiting lower risk for mutation
• GeneOne RT-PCR COVID-19 Kit
--COVID-19 real-time PCR assay contain three primer/probe sets specific to different SARS-CoV-2 genomic regions and primers/probes
• GeneOne COVID-19 Control—RNA control that contains targets specific to the SARS-CoV-2 genomic regions targeted by the assays
• GeneOne COVID-19 Control Dilution Buffer—dilution buffer for the IVT RNA control as defined in the IFU (information for use)
Documents for Download:
Instructions for Use
Fact Sheet for Healthcare Provider
Fact Sheet for Patient
The GeneOne COVID-19 RT-PCR Test Kit contains the assays and controls for a real-time reverse transcription polymerase chain reaction (RT-PCR) test intended for the qualitative detection of nucleic acid from SARS-CoV-2 in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens from individuals suspected of COVID-19 by their healthcare provider. The GeneOne COVID-19 RT-PCR Test Kit is for use only under Emergency Use Authorization (EUA). Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high complexity tests.
Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal swab, nasopharyngeal aspirate, and bronchoalveolar lavage (BAL) specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. The agent detected may not be the definite cause of disease. Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information.
Testing with the GeneOne COVID-19 RT-PCR Test Kit is intended for use by qualified and trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. The GeneOne COVID-19 RT-PCR Test Kit is only for use under the Food and Drug Administration’s Emergency Use Authorization.
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.