ID NOW™
ID NOW™ is an instrument-based, isothermal system for the qualitative detection of infectious diseases using isothermal nucleic acid amplification technology to provide molecular results in minutes. Samples can be taken as a throat, nasal or nasopharyngeal swab. Once the swab is collected, it should be tested immediately.
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
Availability: Commercially Available
+1 224 667 6100
100 Abbott Park Road
Abbott Park, Ill. 60064
USA
|
|
www.abbott.com/
Manufacturer |
| Abbott Laboratories |
Product Name |
| ID NOW™ |
Detection Category |
| Biological |
Detection Principle |
| Molecular; |
Detection Method |
| Nucleic Acid Amplification; |
Application |
| Detection;Diagnostics; |
Product Model Number |
| NAT-024 |
Equipment Type |
| Instrument |
Product Synopsis |
| ID NOW™ is an instrument-based, isothermal system for the qualitative detection of infectious diseases using isothermal nucleic acid amplification technology to provide molecular results in minutes. Samples can be taken as a throat, nasal or nasopharyngeal swab. Once the swab is collected, it should be tested immediately.
The ID NOW COVID-19 EUA has not been FDA cleared or approved. It has been authorized by the FDA under an emergency use authorization for use by authorized laboratories and patient care settings. The test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. |
Availability |
| Commercially Available |
Technology Readiness Level (TRL) |
| 9 |
Market Entry Date |
| 2020 |
User Feedback Sources |
| Indifferent/No user feedback |
Dimensions |
| Size of a toaster |
Weight |
| <30 Lbs.; 6.6 Lbs. (3 kg) |
Power Requirements |
| AC/DC Line power |
Noise Produced |
| Negligible |
Transportability |
| Benchtop/Fixed; Small Footprint |
Ruggedness |
| None |
Operating Conditions |
| Once the swab is collected, it should be tested immediately. If that is not possible, it can be held for two hours at room temperature prior to testing or 24 hours if kept at 2-8°C (35.6-46.4°F). Samples put in transport medium (VTM) should not be used with ID NOW for COVID-19. |
Consumables |
| <$1,000/year; nasal swabs |
Solvents/Reagents |
| ID NOW uses a liquid solution designed to deactivate the virus and break it apart to expose the RNA.The liquid solution is acidic and includes a detergent. |
Calibration Schedule |
| External Positive and Negative Control Swabs should be tested once with each new shipment received and once for each untrained operator. |
Available Accessories |
| Nasal swabs |
Expected Operational Life |
| Single use test item |
Other Biological Targets |
| Strep A, Influenza A, Influenza B, RSV, SARS-CoV-2 (EUA) |
Sample Introduction |
| Liquid; |
Sensitivity/Detection Limits |
| cfu/mL; <1,000 cfu |
False Positive Rates |
| In Covid-19 studies among urgent care clinics found ID NOW has =94.7% positive agreement (sensitivity) and =98.6% negative agreement (specificity) when compared to two different lab-based PCR reference tests. |
Response Time (Sample Application To Output) |
| <15 minutes |
Total Run Time |
| <13 minutes |
Software Control |
| On-Board |
Training Required |
| <1 day training |