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Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, to perform high,
moderate, or waived complexity tests and for use at the Point of Care (POC), i.e., in patient care
settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of
Accreditation.
7. Federal Law restricts this device to sale by or on the order of a licensed practitioner (US only).
8. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any
other viruses or pathogens.
9. Laboratories within the United States and its territories are required to report all results to the
appropriate public health laboratories.
10. To be used in conjunction with the ID NOW Instrument.
11. Treat all specimens as potentially infectious. Follow universal precautions when handling samples,
this kit and its contents.
12. Proper sample collection, storage and transport are essential for correct results.
13. Leave test pieces sealed in their foil pouches until just before use.
14. Do not tamper with test pieces prior to or after use.
15. Do not use kit past its expiration date.
16. Do not mix components from different kit lots or from other ID NOW assays.
17. Solutions used to make the p ositive control swab are inactivated using standard methods. However,
patient samples, controls, and test pieces should be handled as though they could transmit disease.
Observe established precautions against microbial hazards during use and disposal.
18. Wear clean personal protection equipment and gloves when running each te st. Change gloves
between the handling of specimens suspected of COVID-19.
19. If any assay components are dropped, cracked, found to be damaged or opened when
received, DO NOT USE and discard. Do not use scissors or sharp objects to open foil
pouches as damage to test pieces can occur.
20. Do not open the Sample Receiver before placing in the instrument. It will prohibit the Elution
Buffer from reaching temperature and may impact test performance.
21. If the Sample Receiver is spilled while opening, clean the instrument per instructions provided in
the instrument User Manual and cancel test. Repeat test with a new Sample Receiver.
22. All test pieces must be removed from the instrument according to removal instructions displayed
on the instrument and disposed of according to country and local requirements. Pieces must not
be separated once they are assembled.
23. All test pieces are single use items. Do not use with multiple specimens.
24. Once reacted, the Test Base contains large amounts of amplified target (Amplicon). Do not
disassemble the Test Base and Transfer Cartridge. In the case of a positive sample, this
could lead to amplicon leakage and potential ID NOW COVID-19 false positive test results.
25. At a low frequency, clinical samples can contain inhibitors that may generate invalid results. Site
to site invalid rates may vary.
26. Due to the high sensitivity of the assays run on the instrument, contamination of the work area with
previous positive samples may cause false positive results. Handle samples according to standard
laboratory practices. Clean instruments and surrounding surfaces according to instructions
provided in the cleaning section of the instrument User Manual. Refer to Section 1.6, Maintenance
& Cleaning, for further information.
STORAGE AND STABILITY
Store kit at 2-30°C. The ID NOW COVID-19 kit is stable until the expiration date marked on the outer
packaging and containers. Ensure all test components are at room temperature before use.
QUALITY CONTROL
ID NOW COVID-19 has built-in procedural controls. The result of the Procedural Control is d isplayed on
the screen and is automatically stored in the instrument with each test result. This can be reviewed later by
selecting Review Memory on the instrument.
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