This document is a supplement to the manufacturer’s instructions and is intended to provide helpful testing tips when using the Abbott BinaxNOW™ COVID-19 Ag Card test. To ensure accurate performance of this test, please refer to the package insert or Instructions for Use for complete details on how to perform the test. Additional instructions can be found at www.fda.gov/media/141570/download. For information on the Abbott BinaxNOW™ COVID-19 Ag Card Test, please view the manufacturer’s website at https://www.globalpointofcare.abbott/en/support/ product-installation-training/navica
Before the Test
Make sure to label specimen or test card correctly to avoid record-keeping issues.
Gloves should be changed immediately after collecting, handling, and processing a new specimen. Discard used gloves in a biohazardous waste container.
Specimens should be tested right away, or within 1 hour after collection with proper storage in a sealed, clean, unused transport tube. If specimens are not tested within 1 hour of collection, testing is not recommended because false negative results can occur. If greater than a 1 hour delay occurs, dispose of the sample swab in a biohazardous waste container and collect a new specimen for testing. Do not use viral transport media for specimen storage. 1 Store kit at 2-30°C (35.6-86° F). Do not freeze kits. Test kit reagents/cards must be at room temperature before use. If stored in a refrigerator, allow time to warm up to room temperature. Only the swabs provided with the kit are approved for use with test. Do not use other swabs. Acceptable specimens include nasal swabs obtained by collection from both nostrils. Do not return specimen to original paper packaging once it has been opened. It is important for new operators to receive adequate training on how to successfully test the system with the controls before beginning specimen processing. In an untested BinaxNOW COVID-19 Ag Card there will be a blue line present at the Control Line position. Do not use the card if the blue line is not present. Quality control testing should also be performed after receiving new shipments of test kits. Training should include successfully testing one positive and one negative control. For supervisors managing the testing process, additional quality control kits, including 10 positive swabs, are available from the manufacturer. 60′ Positive Result Pink/Purple Sample Line Pink/Purple Control Line Negative Result Pink/Purple Control Line 2