Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection, PCR, Varies

GTR Test IDHelpEach Test is a specific, orderable test from a particular laboratory, and is assigned a unique GTR accession number. The format is GTR00000001.1, with a leading prefix 'GTR' followed by 8 digits, a period, then 1 or more digits representing the version. When a laboratory updates a registered test, a new version number is assigned.: GTR000592499.2
Last updated: 2021-07-14
Annual Review past due read more
Test version history
- 592499.2, last updated: 2021-07-14
- 592499.1, last updated: 2021-04-01

Clinical microbial testHelpIn the U.S., clinical tests must be performed under CLIA certification. When a lab uses the same methods for a test in both clinical and research settings, the test appears as two separate GTR records. for COVID-19
Offered by Clinical Microbiology

Performance Characteristics

Entire test performed in-house
Hepatitis HIV Serology - Superior Drive Support Center, Rochester, MN

The SARS-CoV-2 PCR assay on the PerkinElmer platform has ≥95% accuracy to detecting and reproducibility SARS-CoV-2 RNA.

Citations

Not provided

The FDA has provided emergency use authorization (EUA) of this test for testing human nasopharyngeal and oropharyngeal swab specimens. The sensitivity of the assay is dependent on the timing of the specimen collection (in relation to symptom onset), quality, and type of the specimen submitted for testing. The test is specific for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), and positive test results do not exclude the possibility of concurrent infection with other respiratory viruses. Undetected (ie, negative) results do not rule out COVID-19 in patients and should not be used as the sole basis for treatment or other patient management decisions. Result should be correlated with the patient's history and clinical presentation.

Is proficiency testing performed for this test? HelpWhether the test undergoes periodic internal or external evaluation of the accuracy of test results. Lab-provided.: No

FDA Category Designation: EUA - Emergency Use Authorization

Reviews

Clinical resources

Practice guidelines

NICE, 2024
UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19, 2024
PAGAA, 2022
Guidance for COVID-19 and People With HIV, 2022

Consumer resources

MedlinePlus

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Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) RNA Detection, PCR, Varies

Performance Characteristics

Availability

Analytical Validity

Citations

Assay Limitation(s)

Proficiency Testing (PT)

FDA Regulatory Clearances of the Test

Reviews

Clinical resources

Practice guidelines

Consumer resources