The test will be performed multiple times per day with results reported within 48 hours of receipt of specimen in the laboratory contingent upon testing capacity.
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Real-time PCR by Abbott SARS-CoV-2
Real-time PCR by Abbott Alinity SARS-CoV-2
Real-time PCR by TaqPath COVID-19 Combo kit
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.
Testing is performed by real-time reverse transcription polymerase chain reaction using either the Abbott RealTime SARS-CoV-2 assay, Abbott Alinity m 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 nasal, nasopharyngeal (NP), oropharyngeal (OP) swabs and BAL specimens 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 and Abbott Alinity SARS-CoV-2 assays both involve 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 ranges may change over time. Please refer to the original patient report when evaluating results.
Gently insert mini-tipped flocked nasopharyngeal swab (swab on flexible plastic shaft) through the nostril and into the nasopharynx, reaching the posterior nasopharynx. Gently rotate swab, then remove, and break swab off into tube of transport media– M4RT, CDC recipe viral transport media, Hardy Diagnostics viral transport media or phosphate-buffered saline (PBS). Make sure the swab is fully immersed in the transport media, and that the shaft is short enough to completely tighten the cap. 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…
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…