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Test Code LAB20093 COVID-19 PCR (ID NOW)

Performing Lab

Arnot Ogden Medical Center
Ira Davenport Memorial Hospital

Ordering Recommendations

Rapid and accurate detection of COVID-19/SARS COV-2.

 

AOMC: THIS TEST IS CURRENTLY BEING PERFORMED ONLY FOR SELECT PATIENTS.
        Please contact the Laboratory to discuss current testing strategy.
 

Collect

Nasal swab: Only use the swab provided in the collection kit.

Collection Device

For collection swabs, please call the Laboratory.

Collection Instructions

Nasal swab: MUST use the swab in the collection kit. Carefully insert the swab into the nostril exhibiting the most visible drainage or the nostril that is most congested if drainage is not visible. Using gentle rotation, push the swab until resistance is met at the level of the turbinates (less than one inch into the nostril). Rotate the swab several times against the nasal wall then slowly remove from the nostril.

Place the swab in the sterile tube provided and send to lab at room temperature.

**Testing must be completed within 1 hour of collection.**

Unacceptable Conditions

Specimens that exceed stability limits are unacceptable and will be rejected

  • Specimens > 1 hour old will be rejected
  • Specimens collected using swabs other than those provided by the lab for this specific test will be rejected
  • Specimens that do not meet current laboratory labeling policies will be rejected
  • Specimens that have been held refrigerated will be rejected
  • Specimens submitted to lab in the swab wrapper rather than a sterile tube will be rejected

Stability (from collection to initiation)

Room temperature: 1 hour
 

Storage/Transport Temperature

Room temperature

Interpretive Data

LIMITATIONS:

  • The performance of the ID NOW COVID-19 2.0 test was evaluated using the procedures provided in the product insert only. Modifications to these procedures may alter the performance of the test.
  • Negative results should be treated as presumptive and, if inconsistent with clinical signs and symptoms or necessary for patient management, should be confirmed with a different authorized or cleared molecular test in a CLIA certified laboratory meeting requirements to perform high or moderate complexity tests.
  • False negative results may occur if a specimen is improperly collected, transported or handled. False negative results may also occur if amplification inhibitors are present in the specimen or if inadequate levels of viruses are present in the specimen. Negative results should be considered in the context of a patient's recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19.
  • As with any molecular test, mutations in the target region could affect primer and/or probe binding, resulting in failure to detect the presence of the virus.
  • The test cannot rule out diseases caused by other bacterial or viral pathogens.
  • This test is intended for testing a swab directly without elution in viral transport media as dilution will result in decreased detection of low positive samples that are near the limit of detection of the test.
  • Swab samples eluted in VTM are not appropriate for use in this test.
  • Puritan PurFlock Ultra Flocked Swabs – Standard Tip, Puritan Mini Rayon Tip and Puritan PurFlock Ultra Flocked Swabs – Mini Tip are not suitable for use with this assay.
  • Mucin may interfere with COVID-19 detection at levels greater than 1% w/v.
  • The clinical performance has not been established in all circulating variants but is anticipated to be reflective of the prevalent variants in circulation at the time and location of the clinical evaluation. Performance at the time of testing may vary depending on the variants circulating, including newly emerging strains of SARS-CoV-2 and their prevalence, which change over time.

Reference Interval

COVID-19 Undetected

Synonyms

COVID 19;SARS COV-2;ICV19;CVID19

Methodology

Isothermal nucleic acid amplification.

Start Date

5/8/2020

Last Review Date

06/20/2025

7/11/25 AP 8/7/2025 KH