ID NOW™ COVID-19

Test Code

COVID19

Preferred Specimen

Swab type puritan foam tip (preferred).
Nasopharyngeal Swab - NO MEDIA

Other Acceptable Specimens

Nasal Swab
Throat Swab

Instructions

To collect a nasopharyngeal swab sample, carefully insert the swab into the nostril exhibiting the most visible drainage, or the nostril that is most congested if drainage is not visible. Pass the swab directly backwards without tipping the swab head up or down. The nasal passage runs parallel to the floor, not parallel to the bridge of the nose. Using gentle rotation, insert the swab into the anterior nare parallel to the palate advancing the swab into the nasopharynx, leave in place for a few seconds, and then slowly rotate the swab as it is being withdrawn.

To ensure proper collection, the swab should be passed a distance that is halfway of that from the nose to the tip of the ear. This is about half the length of the swab. DO NOT USE FORCE while inserting the swab. The swab should travel smoothly with minimal resistance; if resistance is encountered, withdraw the swab a little bit without taking it out of the nostril. Then elevate the back of the swab and move it forward into the nasopharynx.

Specimen Stability

Stability is one hour room temperature.

Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)

Eluted specimens will be rejected.

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. It is comprised of a Sample Receiver, containing elution/lysis buffer, a Test Base, comprising two sealed reaction tubes, each containing a lyophilized pellet, a Transfer Cartridge for transfer of the eluted sample to the Test Base, and the ID NOW Instrument.

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.

To perform the assay, the Sample Receiver and Test Base are inserted into the ID NOW Instrument. The sample is added to the Sample Receiver and transferred via the Transfer Cartridge to the Test Base, initiating target amplification. Heating, mixing and detection are provided by the instrument.

Reference Range

Negative

Performing Laboratory
York Hospital Laboratory

The CPT Codes provided in this document are based on AMA guidelines and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payor being billed. Any Profile/panel component may be ordered separately. Reflex tests are performed at an additional charge.