Test Overview

Test Methodology

Abbott RT-PCR

Test Usage

Results are for the identification of SARS-CoV-2 RNA. The SARS-CoV-2 RNA is generally detectable in nasopharyngeal and oropharyngeal swabs during the acute phase of infection.
Samples with inconclusive test results will be sent to the state public health laboratory for further testing.
Testing is performed by real-time reverse transcription polymerase chain reaction using either the Abbott RealTime SARS-CoV-2 assay or the TaqPath COVID-19 Combo kit. Both assays are intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal (NP) and oropharyngeal (OP) swabs from patients suspected of COVID-19 by their health care provider. 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. These assays are 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. These assays are only for use under the Food and Drug Administration’s Emergency Use Authorization.

The Abbott RealTime SARS-CoV-2 assay involves the amplification of the two targets (SARS-CoV-2 RdRp and N genes) as well as an internal control. The lower limit of detection of this assay is 100 copies/mL.
The TaqPath COVID-19 Combo kit involves the amplification of three targets (SARS-CoV-2 ORF1ab, N and S) as well as an internal control. The lower limit of detection of this assay is 250 copies/mL (10 copies per reaction).

Reference Range*

Not detected

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

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. 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.
Optimum specimen types and timing for peak viral levels during infections caused by SARS-CoV-2 have not been determined. Collection of multiple specimens from the same patient may be necessary to detect the virus. The possibility of a false negative result should especially be considered if the patient’s recent exposures or clinical presentation suggest that SARS-CoV-2 infection is possible and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. If SARS-CoV-2 infection is still suspected, re-testing should be considered in consultation with public health authorities.

Test Details

Days Test Performed

Daily

Analytic Time

The test will be performed multiple times per day with results reported within 24 hrs of receipt of specimen in the laboratory contingent upon testing capacity.

Soft Order Code

COVID

MiChart Code

COVID

Synonyms

Synonyms

SARS-CoV-2

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Laboratory

Microbiology

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Specimen Requirements

Offsite Collection Instructions

MLabs has limited supplies of NP swabs and transport media. Please contact client services at 800-862-7284 to determine availability of supplies for your testing needs. MLabs can accept testing from clients that provide their own collection supplies.
Specimen Collection: With the head in a tiled position, insert the swab into one nostril, advancing into the nasopharynx until resistance is felt. Rotate the swab several times on the nasopharyngeal membrane to allow adequate collection of epithelial cells - a minimum of 3 "full twists" is standard to obtain a good collection; if unsure you maintained contact with the membrane, add another 1-2 full twists.
Insert swab into viral transport media or phosphate buffered saline. Break off swab stick at the breakpoint to ensure it will fully fit into the closed tube. Fasten the cap tightly to prevent leakage. Refrigerate.
Send to the laboratory as soon as possible. Obtaining columnar epithelial cells will enhance reliability of viral detection. Please see CDC for current sample collection guidance: https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-speci…

Special Handing

MLabs has limited supplies of NP swabs and transport media. Please contact client services at 800-862-7284 to determine availability of supplies for your testing needs. MLabs can accept testing from clients that provide their own collection supplies.

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Additional Information

Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Additional information from the CDC can be found below:
• COVID-19: https://www.cdc.gov/coronavirus/2019-ncov/index.html

Additional information about the interpretation and use of the Abbott RealTime SARS-CoV-2 assay can be found within the following fact sheets:
Health Care Providers: https://www.molecular.abbott/sal/3-EUA200023-HCP-FS-03182020.pdf
Patients: https://www.molecular.abbott/sal/4-EUA200023-Abbott-Patient-FS-03182020…

Additional information about the interpretation and use of the TaqPath COVID-19 Combo kit can be found within the following fact sheets:
Healthcare Providers: https://www.fda.gov/media/136111/download
Patients: https://www.fda.gov/media/136114/download

Billing Information

Fee Codes


CPT Code

87635

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