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Test Code COVIDRPCR COVID19 PCR

Infectious

Collection Method

Nasopharyngeal swab

Container

NPSWAB

Instructions/Special Handling

  • 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.

Preferred Specimen

NPSWAB

Acceptable Specimes

NPSWAB

Units

N/A

Reference Ranges


 

SARS-CoV-2 POSITIVE

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. 

SPC:NA; SPC is ignored because coronavirus target amplification occurred.
SARS-CoV-2 PRESUMPTIVE POSITIVE

The 2019 novel coronavirus (SARS-CoV-2) nucleic acids may be present. Sample should be retested. 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 E nucleic acid target has a Ct within the valid range and endpoint above the minimum setting

SPC: NA; SPC is ignored because a target amplification has occurred
SARS-CoV-2 NEGATIVE

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 

SPC: PASS; SPC has a Ct within the valid range and endpoint above the minimum setting.
INVALID

SPC does not meet acceptance criteria. Presence or absence of the 2019 novel coronavirus (SARS-CoV-2) nucleic acids cannot be determined. Repeat test according to the Retest Procedure. 

SPC:FAIL; SPC and SARS-CoV-2 signals do not have a Ct within valid range and endpoint below minimum setting
ERROR

Presence or absence of the 2019 novel coronavirus (SARS-CoV2) nucleic acids cannot be determined. Repeat test according to the Retest Procedure 

SARS-CoV-2: NO RESULT

SPC: NO RESULT
NO RESULT

Presence or absence of the 2019 novel coronavirus (SARS-CoV2) nucleic acids cannot be determined. Repeat test according to the Retest Procedure. A NO RESULT indicated that insufficient data were collected. For example, the operator stopped a test that was in progress. 

SARS-CoV-2: NO RESULT

SPC: NO RESULT

 

Critical Values

N/A

Reasons for Rejection

 

Hemolysis N/A
Icterus N/A
Lipemia N/A
Other QNS, Contaminated, Improperly labeled, Improper specimen type

Specimen Stability

Ambient (15-25°C) 8 hours
Refrigerated (2-8°C) 7 days
Frozen (-20°C) N/A

 

Performing Site

Boone Health Laboratory

Performance Information

Days/Times Performed Daily 24/7
Expected Turn around Time Same day
Methodology/Method Description Cepheid

CPT Code(s)

U0003