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).
Test performance varies by site of sample collection. In situations where maximum sensitivity is needed for patient care or infection prevention, a nasopharyngeal swab sample is recommended.
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.
Based on literature review and in-house evaluation of saliva samples collected in parallel with nasopharyngeal swabs, saliva approaches, but may not equal, the sensitivity of nasopharyngeal samples for detection of SARS-CoV-2. Therefore, saliva is recommended for use in patients for whom it improves access to SARS-CoV-2 diagnostic testing. In situations where maximum sensitivity is needed for patient care or infection prevention, a nasopharyngeal swab sample is recommended.
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.
Please contact client services at 800-862-7284 to determine availability of supplies for your testing needs.
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 (specimen may be stored at room temperature for up to 24 hours).
Send to the laboratory as soon as possible. Obtaining columnar epithelial cells will enhance reliability of viral detection.
Saliva collection instructions: DO NOT eat, drink, chew gum, or smoke for 30 minutes prior to sample collection. If possible, drink a glass of water 45-60 minutes prior to collection. Gather saliva in your mouth and gently drool into an orange-capped sterile collection cup. The goal is to collect 1 to 5 mL of saliva. At minimum, fill above the ridged line at the bottom of the cup. Bubbles do not count towards the needed volume. This should take 2-5 minutes to get enough sample. Be sure to close the container tightly. Refrigerate. Send to the laboratory as soon as possible.
Please see CDC for current sample collection guidance: https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-speci…
Please refer to Michigan Medicine COVID testing guidelines for recommended specimen type based on test indication:
1 to 5 ml of saliva. At minimum, fill above the ridged line at the bottom of the cup.
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
On December 15, 2020, the Clinical Microbiology Laboratory will begin pooling selected Michigan Medicine patient specimens for COVID19 PCR testing. Our pooled SARS-CoV-2 RT-PCR protocol will consist of combining five individual patient specimens into one pooled test sample for testing using our Abbott Alinity instrument. In cases where the pool of five is negative, each of the five patient specimens will be reported as negative with a comment indicating the test was done in a pooled manner. In the case of a positive pool, each of the five patient specimens will be re-tested individually and reported as positive or negative based on the individual test result.
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
Additional information about the interpretation and use of the Abbott Alinity SARS-CoV-2 assay can be found within the following fact sheets:
Health Care Providers: https://www.fda.gov/media/137978/download
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