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COVID-19 Diagnostic Genetic Test

Justification

This test can rapidly diagnose active infection from patients who are symptomatic, presymptomatic, or asymptomatic, facilitating proper quarantine, contact tracing, hospitalization, and treatment. A major obstacle in controlling the (COVID-19) pandemic is that patients are contagious while presymptomatic or asymptomatic.

STAT: < 24 hours (M-F)

RT-LAMP

Draw Tube: Buccal Swab

Sample Type: Buccal Swab

DRAW KITS AVAILABLE

Specimen Requirements

Sample Type Volume Required Minimum Volume Stability
PREFERRED Buccal Swab 1 Buccal Swab 1 Buccal Swab Room Temperature: 4 days
ALTERNATIVE Respiratory swab or nasopharyngeal swab 1 swab - 4 day at room temperature
REJECTION CRITERIA Sample contamination; sample compromised
SPECIAL INSTRUCTIONS -

General Information

METHODOLOGY RT-LAMP
STAT TAT < 24 hours (M-F)
STAT TAT Performance > 99% of results released in 24 hours
ROUTINE TAT < 24 hours (M-F)
ALTERNATIVE NAMES COVID-19 genetic test, nucleic acid amplification testing (NAAT), SARS-CoV-2 diagnostic assay, SARS-CoV-2 RNA test, RT-LAMP, COVID-19 molecular test, COVID-19 PCR equivalent test
DESCRIPTION The analytic sensitivity of this test is greater than 99%; the analytic specificity of this test is greater than 99%. The lower limit of detection (LoD) is 3 viral copies per reaction. Our rapid COVID-19 Diagnostic Genetic Test is a molecular assay for the qualitative detection of SARS-CoV-2 viral RNA from respiratory samples or self-administered mouth swabs. Oligonucleotide primers are used to specifically and rapidly amplify DNA from reverse transcribed viral RNA in a method called reverse transcription loop-mediated isothermal amplification. This test has been submitted for Emergency Use Authorization (EUA) from the Food and Drug Administration (FDA). EAU Submission Number: EUA202673
LIMITATIONS This test will miss positive cases in the initial post-infection window (first ~3 days) since there is not yet enough virus present to be detected. Due to the strong sensitivity of this test, patients may continue to test positive for several weeks after recovery. 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. False negatives are generally thought to be a failure to properly sample the upper respiratory tract or from the infection migrating to the lower respiratory tract. Rare mutations that disrupt primer binding would also result in a false negative. This test is qualitative and a positive result does not distinguish between those who have an active infection and are highly contagious versus those who have mostly resolved the infection, are still shedding viral RNA, but are likely not contagious.
NORMAL RANGE Negative
ASSOCIATED TESTING -
REFERENCES

1. C. Yan et al. Rapid and visual detection of 2019 novel coronavirus (SARS-CoV-2) by a reverse transcription loop-mediated isothermal amplification assay. Clin Microbiol Infect. 2020;26(6):773-779.

2. R. Lu et al. A novel Reverse Transcription Loop-Mediated Isothermal Amplification Method for Rapid Detection of SARS-CoV-2. Int J Mol Sci. 2020;21(8):2826

3. X. Hu et al. Development and Clinical Application of a Rapid and Sensitive Loop-Mediated Isothermal Amplification Test for SARS-CoV-2 Infection. mSphere. 2020;5(4):300808-20

4. Y. H. Baek et al. Development of a reverse transcription-loop-mediated isothermal amplification as a rapid early-detection method for novel SARS-CoV-2. Emerg Microbes Infect. 2020;9(1):988-1007.
SAMPLE REPORT Upon request
NEW YORK STATE APPROVED -

Test Codes

ORDER CODE P3406
CPT CODE 87635
LOINC CODE 31208-2, 94500-6