Collect

Collect nasopharyngeal specimen using a flocked swab and Viral Transport Media (VTM). Swab should remain in the VTM tube following collection and should not be discarded.
Oropharyngeal source is acceptable in addition to the Nasopharyngeal source, and can be sent in 3.0 mL of VTM, UTM or saline.

Preferred Container

Specimen Preparation

If sample will not be received at the performing lab location within 48 hours, then store refrigerated after collection while awaiting transportation.

What if I have a frozen sample, but I do not have dry ice to transport the specimen? The most important piece is denoting that the sample had been frozen on the lab order form, as we have to perform an extra set-up step for these samples. If unable to place on dry ice for transport, it should remain frozen and then be placed on cold packs for transport.

Onsite Collection Instructions

Transport to laboratory immediately following collection.

Offsite Collection Instructions

If sample will not be received at the performing lab location within 48 hours, then store refrigerated after collection while awaiting transportation.

What if I have a frozen sample, but I do not have dry ice to transport the specimen? The most important piece is denoting that the sample had been frozen on the lab order form, as we have to perform an extra set-up step for these samples. If unable to place on dry ice for transport, it should remain frozen and then be placed on cold packs for transport.

Stability (from collection to initiation)

Sample is stable at room temperature for 48 hours or up to 7 days when refrigerated.
If specimen is frozen, it must be denoted on the requisition for special handling and set-up. If unable to place on dry ice for transport, it should remain frozen and then be placed on cold packs for transport.

Required Testing Volume

3.0 mL - NP swab in VTM, UTM, or saline
or 3.0 mL - OP swab in VTM, UTM, or saline

Storage/Transport Temperature

Sample is stable at room temperature for 48 hours or up to 7 days when refrigerated. 
If sample will not be received at the performing lab location within 48 hours, then store refrigerated after collection while awaiting transportation (on cold packs).

Unacceptable Conditions

Only nasopharyngeal or oropharyngeal swabs will be accepted

Preferred Specimen Source

Nasopharyngeal swab in VTM or Oropharyngeal swab in VTM

Alternate Specimen Source

Nasopharyngeal swab in UTM/saline or Oropharyngeal swab in UTM/saline

Performed

Daily

Ordering Recommendations

For inpatients and symptomatic healthcare workers.

Turn Around Time

6 hours

Performing Lab

Molecular Microbiology

Methodology

Real-time PCR

Synonyms

  • COVID

Reference Interval

Detected / Not Detected

Interpretive Data

This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only. Negative results do not preclude infection with SARS CoV 2 virus and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to the current CDC recommendations.


Abbott Molecular - Alinity m SARS-CoV-2 assay - Real-time RT-PCR
This test was performed using the Abbott SARS-CoV-2 Test, a qualitative PCR-based assay. The limit of detection (LoD) for this assay is 100 copies/mL. Reference Range: Not Detected
Providers Fact Sheet
https://www.fda.gov/media/137978/download

Patient Fact Sheet
https://www.fda.gov/media/137981/download
IFU
https://www.fda.gov/media/137979/download


Becton, Dickinson & Company - BioGX SARS-CoV-2 Reagents for BD Max System - Real-time RT-PCR
This test was performed using BioGX SARS-CoV-2 Reagents for BD Max, a qualitative PCR-based assay. The limit of detection (LoD) for this assay is 40 genome equivalents/mL. Reference Range: Not Detected
Providers Fact Sheet
https://www.fda.gov/media/136652/download

Patient Fact Sheet
https://www.fda.gov/media/136651/download
IFU
https://www.fda.gov/media/136653/download


Cepheid - Xpert Xpress SARS-CoV-2/Flu/RSV - Real-time RT-PCR, Multi-analyte
This test was performed using the Cepheid GenXpert SARS-CoV-2/Flu/RSV Test, a qualitative PCR-based assay. The limit of detection (LoD) for this assay is 131 copies/mL. Reference Range: Not Detected
Providers Fact Sheet
https://www.fda.gov/media/142435/download

Patient Fact Sheet
https://www.fda.gov/media/142436/download
IFU
https://www.fda.gov/media/142436/download

 

Laboratory Department

Microbiology
Collection

Collect

Collect nasopharyngeal specimen using a flocked swab and Viral Transport Media (VTM). Swab should remain in the VTM tube following collection and should not be discarded.
Oropharyngeal source is acceptable in addition to the Nasopharyngeal source, and can be sent in 3.0 mL of VTM, UTM or saline.

Preferred Container

Specimen Preparation

If sample will not be received at the performing lab location within 48 hours, then store refrigerated after collection while awaiting transportation.

What if I have a frozen sample, but I do not have dry ice to transport the specimen? The most important piece is denoting that the sample had been frozen on the lab order form, as we have to perform an extra set-up step for these samples. If unable to place on dry ice for transport, it should remain frozen and then be placed on cold packs for transport.

Onsite Collection Instructions

Transport to laboratory immediately following collection.

Offsite Collection Instructions

If sample will not be received at the performing lab location within 48 hours, then store refrigerated after collection while awaiting transportation.

What if I have a frozen sample, but I do not have dry ice to transport the specimen? The most important piece is denoting that the sample had been frozen on the lab order form, as we have to perform an extra set-up step for these samples. If unable to place on dry ice for transport, it should remain frozen and then be placed on cold packs for transport.

Stability (from collection to initiation)

Sample is stable at room temperature for 48 hours or up to 7 days when refrigerated.
If specimen is frozen, it must be denoted on the requisition for special handling and set-up. If unable to place on dry ice for transport, it should remain frozen and then be placed on cold packs for transport.

Required Testing Volume

3.0 mL - NP swab in VTM, UTM, or saline
or 3.0 mL - OP swab in VTM, UTM, or saline

Storage/Transport Temperature

Sample is stable at room temperature for 48 hours or up to 7 days when refrigerated. 
If sample will not be received at the performing lab location within 48 hours, then store refrigerated after collection while awaiting transportation (on cold packs).

Unacceptable Conditions

Only nasopharyngeal or oropharyngeal swabs will be accepted

Preferred Specimen Source

Nasopharyngeal swab in VTM or Oropharyngeal swab in VTM

Alternate Specimen Source

Nasopharyngeal swab in UTM/saline or Oropharyngeal swab in UTM/saline

Performed

Daily
Ordering

Ordering Recommendations

For inpatients and symptomatic healthcare workers.

Turn Around Time

6 hours

Performing Lab

Molecular Microbiology

Methodology

Real-time PCR

Synonyms

  • COVID
Result Interpretation

Reference Interval

Detected / Not Detected

Interpretive Data

This assay is for in vitro diagnostic use under FDA Emergency Use Authorization only. Negative results do not preclude infection with SARS CoV 2 virus and should not be the sole basis of a patient treatment/management or public health decision. Follow up testing should be performed according to the current CDC recommendations.


Abbott Molecular - Alinity m SARS-CoV-2 assay - Real-time RT-PCR
This test was performed using the Abbott SARS-CoV-2 Test, a qualitative PCR-based assay. The limit of detection (LoD) for this assay is 100 copies/mL. Reference Range: Not Detected
Providers Fact Sheet
https://www.fda.gov/media/137978/download

Patient Fact Sheet
https://www.fda.gov/media/137981/download
IFU
https://www.fda.gov/media/137979/download


Becton, Dickinson & Company - BioGX SARS-CoV-2 Reagents for BD Max System - Real-time RT-PCR
This test was performed using BioGX SARS-CoV-2 Reagents for BD Max, a qualitative PCR-based assay. The limit of detection (LoD) for this assay is 40 genome equivalents/mL. Reference Range: Not Detected
Providers Fact Sheet
https://www.fda.gov/media/136652/download

Patient Fact Sheet
https://www.fda.gov/media/136651/download
IFU
https://www.fda.gov/media/136653/download


Cepheid - Xpert Xpress SARS-CoV-2/Flu/RSV - Real-time RT-PCR, Multi-analyte
This test was performed using the Cepheid GenXpert SARS-CoV-2/Flu/RSV Test, a qualitative PCR-based assay. The limit of detection (LoD) for this assay is 131 copies/mL. Reference Range: Not Detected
Providers Fact Sheet
https://www.fda.gov/media/142435/download

Patient Fact Sheet
https://www.fda.gov/media/142436/download
IFU
https://www.fda.gov/media/142436/download

 
Administrative

Laboratory Department

Microbiology