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GTR Home > > Inform Diagnostics V2.0 SARS-CoV-2 RT-PCR assay


Test name


Inform Diagnostics V2.0 SARS-CoV-2 RT-PCR assay

Purpose of the test


This is a clinical microbial test intended for Help: Diagnosis, Screening



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Click Indication tab for more information.

How to order


Applies to CPT codes: u0003, u0005
Order URL Help: https://www.informdx.com/wp-content/uploads/Inform-Dx-COVID-19-Test-Requisition.pdf

Specimen source

Nasopharyngeal (NP) swab
Oropharyngeal swab

Sample requirements

Saliva or Swab Specimen. Saliva Specimens - Important for Saliva Specimens: do not eat, drink, smoke, vape, or chew gum for 30 minutes before saliva specimen collection; Volume for Saliva - Fill with saliva as indicated on package. Swab Specimen - nasopharyngeal or oropharyngeal specimen, in transport vial containing viral transport media (such as UTM® or UVT®) or sterile saline; Volume for Swab - 1 mL. Shipping requirements: Store at 2–8°C and ship overnight on ice pack, or store frozen at -70°C and ship overnight on dry ice. Special Notes: Multiple Swabs or Saliva Specimens from the same patient can be combined in a single vial for testing. Each specimen vial should be enclosed in a biohazard bag, then placed in the 95kPa Transport Bag (if using our provided kit) to avoid leakage during transportation, then securely seal the front pocket of the bag by peeling away the white tape and folding the adhesive down to cover the opening. Each specimen requires a separate requisition; for safety, place the requisition OUTSIDE of the specimen bag(s). Criteria for rejection: Specimen container is unlabeled/mislabeled; Specimen collected using calcium alginate tips, swabs with preservatives, or cotton swabs with wooden shafts; Specimen stored at 4°C received more than 72 hours after collection; Broken or leaking containers; Improper transportation conditions, per instructions above

Turnaround time

2 days


Molecular Genetics
RRNA analysis
  • Applied Biosystems™ 7500 real-time PCR system
  • ViralXPress

Summary of what is tested

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Click Methodology tab for more information.

Clinical utility


Not provided

Clinical validity


Not provided

Positive and negative predictive values (PPV and NPV)

PPV: 100%, NPV: 100%

Clinical resources

Practice guidelines

  • NICE, 2024
    UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19, 2024

Consumer resources

IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.