Nasopharyngeal swab in Viral or Universal Transport Media
Nasal swab in Viral or Universal Transport Media
Bronchoalveolar Lavage (BAL)
Bronchial Washing
Tracheal Aspirate
Specimen Preparation
1. Label specimen with Cerner label (if available)
2. Place each specimen in individual biohazard bag
3. Place absorbent material in bag with specimen (do NOT wrap)
4. Place bagged specimen in a 2nd biohazard bag
5. Label as PUI (Patient Under Investigation)
6. Place extra labels, requisition forms and/or transfer lists in the outside bag pocket
Unacceptable Conditions
Mislabeled, improperly transported or handled, leaking from tube or shows signs of potential contamination
BayCare Esoteric Lab - 7 days/week
Turn around time ~1 day
Methodology
Roche (manufacturer)
The Roche assay is based on PCR (Polymerase Chain Reaction) and targets the ORF1/a and E gene of the virus.
The LOD (Limit of Detection) for the assay is ~50-150 copies/mL for naso-pharyngeal swabs placed in transport media and ~150-500 copies/mL for other specimen types [verified in lab, limited studies]
This assay has been approved by the FDA as an IVD (In Vitro Diagnostic) test.
Synonyms
Coronavirus
SARS-CoV-2
Reference Interval
Negative
Interpretive Data
This test is for the detection of SARS-CoV-2 Coronavirus that causes the respiratory disease COVID-19.
A Positive result indicates that RNA from SARS-CoV-2 (formerly 2019-nCoV) was detected, and that the patient is considered infected with the virus and presumed to be contagious.
A Negative test result indicates that SARS-CoV-2 RNA was not detected. Negative results should be interpreted in combination with clinical observations and patient history.
An Indeterminate result indicates incomplete detection of targets, which may indicate presence of very low level of virus. Specimen recollection is required.
An Invalid result indicates an inadequate specimen. Recollection of an additional sample is recommended if clinically indicated.
The test was performed with the SARS-CoV-2 FDA-approved Roche cobas 6800 assay, utilitzing RT-PCR (reverse transcriptase PCR) technology to amplify SARS-CoV-2 genomic sequences. The test was verified and conducted within the BayCare Health System Laboratories.
Collection
Collect
Nasopharyngeal swab in Viral or Universal Transport Media
Nasal swab in Viral or Universal Transport Media
Bronchoalveolar Lavage (BAL)
Bronchial Washing
Tracheal Aspirate
Specimen Preparation
1. Label specimen with Cerner label (if available)
2. Place each specimen in individual biohazard bag
3. Place absorbent material in bag with specimen (do NOT wrap)
4. Place bagged specimen in a 2nd biohazard bag
5. Label as PUI (Patient Under Investigation)
6. Place extra labels, requisition forms and/or transfer lists in the outside bag pocket
Unacceptable Conditions
Mislabeled, improperly transported or handled, leaking from tube or shows signs of potential contamination
BayCare Esoteric Lab - 7 days/week
Turn around time ~1 day
Methodology
Roche (manufacturer)
The Roche assay is based on PCR (Polymerase Chain Reaction) and targets the ORF1/a and E gene of the virus.
The LOD (Limit of Detection) for the assay is ~50-150 copies/mL for naso-pharyngeal swabs placed in transport media and ~150-500 copies/mL for other specimen types [verified in lab, limited studies]
This assay has been approved by the FDA as an IVD (In Vitro Diagnostic) test.
Synonyms
Coronavirus
SARS-CoV-2
Result Interpretation
Reference Interval
Negative
Interpretive Data
This test is for the detection of SARS-CoV-2 Coronavirus that causes the respiratory disease COVID-19.
A Positive result indicates that RNA from SARS-CoV-2 (formerly 2019-nCoV) was detected, and that the patient is considered infected with the virus and presumed to be contagious.
A Negative test result indicates that SARS-CoV-2 RNA was not detected. Negative results should be interpreted in combination with clinical observations and patient history.
An Indeterminate result indicates incomplete detection of targets, which may indicate presence of very low level of virus. Specimen recollection is required.
An Invalid result indicates an inadequate specimen. Recollection of an additional sample is recommended if clinically indicated.
The test was performed with the SARS-CoV-2 FDA-approved Roche cobas 6800 assay, utilitzing RT-PCR (reverse transcriptase PCR) technology to amplify SARS-CoV-2 genomic sequences. The test was verified and conducted within the BayCare Health System Laboratories.