Collect

Nasopharyngeal 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
7. Hand deliver specimen to laboratory

Unacceptable Conditions

Mislabeled, improperly transported or handled, leaking from tube or shows signs of potential contamination

Stability (from collection to initiation)

Refrigerated (2-8oC) up to 72 hours

Cerner Orderable(s)

COVID 19 (BayCare)

Performed

BayCare Esoteric Lab - 7 days/week
Turn around time ~1 day

Ordering Recommendations

COVID 19 (BayCare) test takes about 1 day for a result.  It should be used when an immediate COVID-19 result is NOT needed to change medical management.  Suggested indications include:
  • ED patients NOT being admitted who still need COVID-19 testing
  • Patients being discharged to a facility (including Behavioral Health) where the discharge is >1 day away
  • Preprocedural/surgical where the procedure/surgery is >1 day away, and the patient has COVID-19 symptoms

Methodology

Roche, DiaSorin, BD (manufacturer)
These assays are based on PCR (Polymerase Chain Reaction).  The Roche assay targets  ORF1/a and E gene of the virus.  The DiaSorin assay targets the S gene and ORF1ab of the virus. The BD assay targets the N1 and N2 genes of the virus.

The LOD (Limit of Detection) for all assays 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]

Pool testing (Pools of 2 samples) is conducted using the Roche assay on a subset of pre-admit patients prior to procedures/surgeries.
All the above assays, including the pool strategy,
are approved by the FDA as EUA (Emergency Use Authorization)

Synonyms

  • Coronavirus
  • SARS-CoV-2

Reference Interval

Negative

Interpretive Data

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 Invalid result indicates an inadequate specimen or incomplete detection of targets.  Recollection of an additional sample is recommended if clinically indicated.

If pooled testing was performed this comment applies:
This test was conducted using a pooling strategy (Pool size = 2 samples); patient specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pool testing. Our internal studies have determined that the impact on test sensitivity is minor.
Negative results should not be used as the sole basis for patient management decisions and must be considered in the context of a patient’s recent exposures, history, presence of clinical signs and symptoms consistent with COVID-19. If negative results are inconsistent with clinical signs and symptoms or necessary for patient management, pooled samples should be tested individually.

 
Collection

Collect

Nasopharyngeal 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
7. Hand deliver specimen to laboratory

Unacceptable Conditions

Mislabeled, improperly transported or handled, leaking from tube or shows signs of potential contamination

Stability (from collection to initiation)

Refrigerated (2-8oC) up to 72 hours
Ordering

Cerner Orderable(s)

COVID 19 (BayCare)

Performed

BayCare Esoteric Lab - 7 days/week
Turn around time ~1 day

Ordering Recommendations

COVID 19 (BayCare) test takes about 1 day for a result.  It should be used when an immediate COVID-19 result is NOT needed to change medical management.  Suggested indications include:
  • ED patients NOT being admitted who still need COVID-19 testing
  • Patients being discharged to a facility (including Behavioral Health) where the discharge is >1 day away
  • Preprocedural/surgical where the procedure/surgery is >1 day away, and the patient has COVID-19 symptoms

Methodology

Roche, DiaSorin, BD (manufacturer)
These assays are based on PCR (Polymerase Chain Reaction).  The Roche assay targets  ORF1/a and E gene of the virus.  The DiaSorin assay targets the S gene and ORF1ab of the virus. The BD assay targets the N1 and N2 genes of the virus.

The LOD (Limit of Detection) for all assays 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]

Pool testing (Pools of 2 samples) is conducted using the Roche assay on a subset of pre-admit patients prior to procedures/surgeries.
All the above assays, including the pool strategy,
are approved by the FDA as EUA (Emergency Use Authorization)

Synonyms

  • Coronavirus
  • SARS-CoV-2
Result Interpretation

Reference Interval

Negative

Interpretive Data

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 Invalid result indicates an inadequate specimen or incomplete detection of targets.  Recollection of an additional sample is recommended if clinically indicated.

If pooled testing was performed this comment applies:
This test was conducted using a pooling strategy (Pool size = 2 samples); patient specimens with low viral loads may not be detected in sample pools due to the decreased sensitivity of pool testing. Our internal studies have determined that the impact on test sensitivity is minor.
Negative results should not be used as the sole basis for patient management decisions and must be considered in the context of a patient’s recent exposures, history, presence of clinical signs and symptoms consistent with COVID-19. If negative results are inconsistent with clinical signs and symptoms or necessary for patient management, pooled samples should be tested individually.

 
Administrative