Waived BNP Test

The meter itself doesn't carry a CLIA status; the magic occurs within the cartridge itself and has passed through FDA governance. While most testing on the QuidelOrtho MeterPro platform does carry a Moderately Complex characterization (D-Dimer, Troponin-I, etc.), the B-type natriuretic peptide (BNP) does carry a waived status when testing whole blood.

A previous ownership of the platform went through the trouble and expense of achieving waived status as one of the more prominent placements of the BNP testing is in the cardiologist's office setting, a setting that frequently has a staffing pattern quite suitable for waived BNP testing. The other test offerings are more suited for the hospital setting; think about the patient who might need D-dimer or Troponin-I testing.

https://www.cdc.gov/clia/docs/tests-granted-waived-status-under-clia.pdf    (see page 16)

https://www.quidelortho.com/global/en/products/triage-meter-pro/quidel-triage-bnp-test#tabs-d349b8be46-item-97d7dfd912-tab