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SARS-CoV-2, NAA (PCR)

Alternate Name: Covid-19_Cobas

  | Covid PCR

SAL Code:

2018

Loinc:

94500-6

Setup:

Daily

Department:

Molecular Diagnostics

Performing Laboratory:

Sherman Abrams Laboratory

Methodology:

Polymerase Chain Reaction (RT-PCR)

Specimen Requirements:

Primary Tube:

VTM

Primary Substance:

BioMat

Alternate Sample Info:

Nasal, nasopharyngeal, and oropharyngeal specimen

Temperature

Period

Stable Ambient:

24 Hours

Stable Fridge:

5 Days

Stable Frozen:

30 Days

Rejection Criteria:

Expired or non-approved collection devices or improperly collected samples. Noticeably leaking samples or samples with obvious PCR inhibitors will be rejected or canceled.

Clinical Info:

This assay is a PCR test that is designed to detect and amplify Sars-CoV-19 in specimens collected. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient's recent exposures and the presence of clinical signs and symptoms consistent with COVID-19. An individual who is not shedding SARS-CoV-2 virus would expect to have a negative (not detected) result in this assay.

Additional Information:

Testing is performed using the Roche Cobas(R) SARS-CoV-2 RT-PCR test. Amplification of target nucleic acids are performed using forward and reverse primers specifically designed for the ORF1, a region unique to SARS-CoV-2. A conserved region in the structural protein envelope E-gene was selected for the detection of pan-Sarbecovirus which will detect SARS-CoV-2. Selective amplification of the RNA internal control is performed using specific primers with no homology with the coronavirus genome.

Negative results do not rule out SARS-CoV-2 infection and should not be used as the sole basis for patient management.

Sample Collection:

Use only synthetic fiber swabs with thin plastic or wire shafts that have been designed for sampling the nasopharyngeal mucosa. Do not use calcium alginate swabs or swabs with wooden shafts, as they may contain substances that inactivate some viruses and may inhibit molecular tests.
Tilt patient’s head back 70 degrees.
Gently and slowly insert a minitip swab with a flexible shaft (wire or plastic) through the nostril parallel to the palate (not upwards) until resistance is encountered or the distance is equivalent to that from the ear to the nostril of the patient, indicating contact with the nasopharynx.
Gently rub and roll the swab.
Leave swab in place for several seconds to absorb secretions.
Slowly remove swab while rotating it. Specimens can be collected from both sides using the same swab, but it is not necessary to collect specimens from both sides if the minitip is saturated with fluid from the first collection.
If a deviated septum or blockage create difficulty in obtaining the specimen from one nostril, use the same swab to obtain the specimen from the other nostril.
Place swab, tip first, into the transport tube provided.
For a visual guide see https://www.cdc.gov/coronavirus/2019-ncov/downloads/lab/NP_Specimen_Collection_Infographic_FINAL_508.pdf

Test Limitations:

Reliable results depend on proper sample collection, storage and handling procedure. This test is intended to be used for detection of SARS-CoV-2 RNA in nasopharyngeal swabs in VTM media. Testing of other sample type may result in inaccurate results. Detection of SARS-CoV-2 RNA may be affected by sample collection methods, patient factors and/or stage of infection. False negative or invalid results may occur due to interference. Internal controls are included to help identify the specimens containing substances that may interfere with nucleic acid isolation and PCR amplification.

Specimen Handling Instructions:

Maintain at ambient temperature; or refrigerated if more than 12 hours. Avoid exposure to heat or freezing temperatures.

Test Information:

Components: