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HelpTest Code COVID RAPID Rapid Covid-19
Additional Codes
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Cerner |
NextGen |
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Covid-19 Rapid |
Covid-19 Rapid |
Methodology
ID NOW COVID-19 is an automated assay that utilizes isothermal nucleic acid amplification technology for the qualitative detection of SARS-CoV-2 viral nucleic acids. The reaction tubes in the Test Base contain the reagents required for amplification of SARS-CoV-2, as well as an internal control. The templates (similar to primers) designed to target SARS-CoV-2 RNA amplify a unique region of the RdRp segment. Fluorescently-labeled molecular beacons are used to specifically identify each of the amplified RNA targets.
Patient Preparation
Specimen should be collected from symptomatic patients within the first seven days of symptom onset.
Collection Instructions
Nasal or nasopharyngeal swabs specimens should be collected according to clinical policies and procedures.
- Carefully insert swab into the nostril exhibiting the most visible drainage or is the most congested.
- 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 5 or more times against the nasal wall, and then slowly remove from the nostril.
- Using the same swab, repeat sample collection in the other nostril.
- Place swab in a clean plastic container with a cap and close tightly for transport.
- Do not place swab back in the paper sleeve or into viral transport media (VTM).
- Label the specimen with patient name, second identifier, source, and date/time of collection.
- Transport specimens to the laboratory immediately.
Specimen Requirements
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Container |
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Stability |
Specimens must be tested within 1 hour of collection |
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Rejection Criteria |
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Result Reporting and Reference Values
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Reference Range |
Negative |
Reflex Testing
None
Limitations
- A negative result is presumptive. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions.
- False negative results may occur if a specimen is improperly collected or handled. False negative results may also occur if amplification inhibitors are present in the specimen or if virus present in the specimen is below the detection limit of the test.
- 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 within the target regions of the ID NOW COVID-19 2.0 could affect primer and/or probe binding resulting in failure to detect the presence of the virus. There is a risk of erroneous results (i.e., false negatives) due to the presence of novel, emerging respiratory viral variants (e.g., specific strains or isolates).
- A negative test result does not preclude the possibility of infection with other bacteria or viruses.
- Positive and negative predictive values are highly dependent on disease prevalence False negative test results are more likely during peak activity when prevalence of disease is high. False positive test results are more likely during periods when prevalence of upper respiratory infection is low in the community.
- Mucin may interfere with COVID-19 detection at levels greater than 1% w/v.
- Zincum gluconium, Zincum aceticum may interfere with COVID-19 detection at levels greater than 10% w/v.
- The clinical performance characteristics of this device were established during the 2020-2021 SARS-CoV-2 pandemic, when the Alpha variant was prevalent; due to the propensity of the virus to mutate, new strains emerge over time which may affect the performance of this device and may have serious public health implications.
- Additional testing with a molecular test and/or sequencing should be considered in situations where a new virus strain or variant is suspected.
Useful For
ID NOW™ COVID-19 2.0 performed on the ID NOW Instrument is a rapid molecular in vitro diagnostic test utilizing an isothermal nucleic acid amplification technology (NAAT) intended for the qualitative detection of nucleic acid from SARS-CoV-2 in direct anterior nasal (nasal) or nasopharyngeal swabs from individuals with signs and symptoms of respiratory tract infection.
ID NOW COVID-19 2.0 performed on theID NOW Instrument is intended for use as an aid in the diagnosis of COVID-19 if used in conjunction with other clinical, epidemiologic, and laboratory findings. SARS-CoV-2 RNA is generally detectable in nasal and nasopharyngeal swab specimens during the acute phase of infection. Positive results are indicative of the presence of SARS-CoV-2 RNA.
Positive results do not preclude co-infection with bacteria or other viruses and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.
A negative test result is presumptive, and it is recommended these results be confirmed by another molecular SARS-CoV-2 assay. Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for diagnosis, treatment, or other patient management decisions.