Overview
Test order codeHelpLaboratory's order or catalog code for the test (used in the order requisition form).: 5408
Psoma Covid-19 RT test (Covid-19 test)
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Microbe identification
Click Indication tab for more information.
Order URL HelpLink to the laboratory webpage with information about how to order this test. Please note that clicking on this link will open a new tab in your internet browser.: https://psomagen.com/covid-test/
Specimen source
Nasal swab
- Molecular Genetics
- RRNA analysis
- RT-qPCR
Not provided
A clinical study was performed to evaluate the performance of the Psoma COVID-19 RT Test. Results obtained with a total of 110 clinical nasopharyngeal swab samples (55 negatives and 55 positives for SARS-CoV-2) tested with FDA EUA RT-PCR assays (TaqPath COVID-19 Method (EUA200010) and LabCorp COVID-19 RT_PCR Test (EUA200011) were compared to results obtained with the Psoma COVID-19 RT Test.
Citations
Not provided
The Psoma COVID-19 RT test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens) and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to Psomagen, Inc. certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high-complexity tests.
Results are for the qualitative detection and identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens) and broncoalveolar lavage 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 infective 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 results to the appropriate public health authorities. 000 The Psoma COVID-19 RT test is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens) and bronchoalveolar lavage specimens from individuals suspected of COVID-19 by their healthcare provider. Testing is limited to Psomagen, Inc. certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a to perform high-complexity tests.
Results are for the qualitative detection and identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens) and broncoalveolar lavage 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 infective 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 results to the appropriate public health authorities.
- Confirmation of research findings
