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Test Code LAB0108 SARS-CoV-2 PCR

Performing Lab

Arnot Ogden Medical Center Laboratory

Ordering Recommendations


This test is intended for the rapid qualitative detection of nucleic acid from the SARS-CoV-2 virus in nasopharyngeal specimens collected from inidividuals suspected of COVID-19 disease.

Collect

Nasopharyngeal swab collected with Viral Transport kit (red top)

Collection Device

Flocked nasopharyngeal swab and approved Transport Medium (red top)

Available from the Laboratory.

Stability (from collection to initiation)


Nasopharyngeal Swab 		Temperature Duration of Stability
Room Temp. Up to 8 hours
2-8C Up to 7 days

Storage/Transport Temperature


Nasopharyngeal Swab 		Temperature Duration of Stability
Room Temp (15-30C) Up to 8 hours
2-8C 7 days

Methodology

Nucleic Acid Amplification

Start Date

5/20/2020

Last Review Date

6/24/2025

Performed

Daily

Reference Interval

Reference Range: Negative

Interpretive Data

  Interpretation
SARS-CoV-2 POSITIVE The 2019 novel coronavirus (SARS-CoV-2) target nucleic acids are detected.
• The SARS-CoV-2 signal for the N2 nucleic acid target or signals for both nucleic acid targets (N2 and E) have a Ct within the valid range and endpoint above the minimum setting.
SARS-CoV-2 PRESUMPTIVE POSITIVE The 2019 novel coronavirus (SARS-CoV-2) nucleic acids may be present.
Sample is retested prior to release. For samples with a repeated Presumptive Positive result, additional confirmatory testing may be conducted, if it is necessary to differentiate between SARS-CoV-2 and SARS-CoV-1 or other Sarbecovirus currently unknown to infect humans, for epidemiological purposes or clinical management.
• The SARS-CoV-2 signal for only the EAdditional  nucleic acid target has a Ct within the valid range and endpoint above the minimum setting.
SARS-CoV-2 NEGATIVE The 2019 novel coronavirus (SARS-CoV-2) target nucleic acids are not detected.
• The SARS-CoV-2 signals for two nucleic acid targets (N2 and E) do not have a Ct within the valid range and endpoint above the minimum setting.

 

  • Performance of the Xpert Xpress SARS-CoV-2 has only been established in nasopharyngeal swab specimens. Specimen types other than nasopharyngeal swab may give inaccurate results.
  • A false negative result may occur if a specimen is improperly collected, transported or handled. False negative results may also occur if inadequate numbers of organisms are present in the specimen.
  • As with any molecular test, mutations within the target regions of Xpert Xpress SARS-CoV-2 could affect primer and/or probe binding resulting in failure to detect the presence of virus.
  • This test cannot rule out diseases caused by other bacterial or viral pathogens.


 

Unacceptable Conditions

  • Specimens that are not submitted in the correct viral transport media will be rejected.
  • Specimens that do not meet the current laboratory standards for labeling will be rejected.
  • Specimens collected using expired collection devices will be rejected.
  • Specimens exceeding stability limits will be rejected.

Lab Section

Microbiology

Collection Instructions

Nasopharyngeal Swab Collection Procedure
Insert the swab into either nostril, passing it into the posterior nasopharynx (see Figure 1). Rotate swab by firmly brushing against the nasopharynx several times. Remove and place the swab into a viral transport tube (3 mL). Break swab at the indicated break line and cap the specimen collection tube tightly.

Reported

Same shift