Baebies FINDER® Flu A&B/SARS-CoV-2 Test – CLIA-Waived RT-PCR Cartridges
(60 Test Cartridges)
FDA 510(k) cleared, CLIA-waived multiplex RT-PCR test that detects and differentiates Influenza A, Influenza B, and SARS-CoV-2 from one nasopharyngeal swab. Positives in as fast as ~15 minutes.
Required items: FINDER® Instrument (BAE-100-000082), FINDER® RVP Buffer (BAE-100-000076), and nasopharyngeal swabs (BAE-999-000032). Run positive and negative controls (BAE-100-000077, BAE-100-000078) per the package insert.
The FINDER® Flu A&B/SARS-CoV-2 Test delivers gold-standard RT-PCR results for the three most common respiratory viruses in a single run on the Baebies FINDER® Instrument. One nasopharyngeal swab tells you whether your patient has Influenza A, Influenza B, or SARS-CoV-2, so you can make treatment decisions during the visit.
Each fully enclosed cartridge comes with reagents preloaded. Multiple gene targets support detection and variant coverage. An endogenous RPP30 control checks specimen adequacy, and more than 100 on-cartridge integrity checkpoints help ensure reliable results.
Clinical performance (prospective study, nasopharyngeal swabs, compared with an FDA-cleared RT-PCR method; FDA 510(k) K252269):
|
Target |
Positive Percent Agreement (95% CI) |
Negative Percent Agreement (95% CI) |
|
SARS-CoV-2 |
97.6% (40/41), 87.4–99.6% |
99.8% (484/485), 98.8–100.0% |
|
Influenza A |
95.4% (62/65), 87.3–98.4% |
97.2% (449/462), 95.2–98.3% |
|
Influenza B |
96.0% (24/25), 80.5–99.3% |
99.4% (499/502), 98.3–99.8% |
Coding and reimbursement:
|
Item |
Detail |
|
CPT code |
87636-QW |
|
Method |
RT-PCR, multiplex amplified probe |
|
CLIA waiver |
CW250011 (510(k) K252269) |
|
Medicare national limit |
$142.63 |
Key features:
- FDA 510(k) cleared and CLIA-waived
- Detects and differentiates Flu A, Flu B, and SARS-CoV-2 from one swab
- Positives in as fast as ~15 minutes; negatives in ~20 minutes
- Fully enclosed cartridge with preloaded reagents
- Endogenous RPP30 specimen adequacy control
- 100+ on-cartridge integrity checkpoints
For in vitro diagnostic use. Rx only. For use with nasopharyngeal swab specimens from individuals with signs and symptoms of respiratory tract infection. Refer to the package insert for complete intended use, limitations, warnings, and precautions.
