Expiration Date: 7/31/2023 - Extended 01/2025
Rapid Covid-19 Flu A + B Combo Test, EAU, Nasopharyngeal
- Requires a CLIA Certificate Number for purchase
- Orders are Non-Cancellable; Item is Non-Returnable
COVID-19/Flu A&B Diagnostic Test
A Rapid Immunoassay for the Simultaneous Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenza Type A and Type B Antigen from nasopharyngeal swab specimens.
COVID-19
- Anterior nasal swab specimen Sensitivity 93.8 %, Specificity 100%
- Nasopharyngeal ? Sensitivity 93.1 %, Specificity 100%
Flu A - Sensitivity 91.4%, Specificity 95.7%
Flu B - Sensitivity 87.6%, Specificity 95.9%
FDA Emergency Use Authorization (EUA)
Visually read in 15 minutes
Flocked nasopharyngeal swab for superior specimen collection and patient comfort
Status COVID-19/Flu A&B:
- USA Manufactured and Delivered
- 3 in 1 Format; Three tests results with one simple procedure
- Test results available in 15 minutes (Visually read in 15 minutes)
- Antigen COVID-19 Test, Accurate detection with nasopharyngeal specimen swab
- Most efficient and cost-effective testing platform for both COVID-19 and Influenza A&B
- Quality manufactured tests and results No equipment needed to perform testing
- Lower operational costs and easier workflow compared to PCR & Reader based products
- All-in-one test which follows the same easy to run procedure as our CLIA Waived Status Flu A&B test
- Superior Sensitivity and Specificity
Specifications:
- COVID-19 (PPA 94%, NPA 100%)
- Flu A - Sensitivity 91.4%, Specificity 95.7% / Flu A (PPA 89.2%, NPA 99.4%)
- Flu B - Sensitivity 87.6%, Specificity 95.9% / Flu B (PPA 86.4%, NPA 99%)
- Nasopharyngeal Sensitivity 93.1 %, Specificity 100%
- Flocked nasopharyngeal swab for superior specimen collection and patient comfort.
- Anterior nasal swab specimen Sensitivity 93.8 %, Specificity 100%
- Only three components needed to run the test; Test Cassette, Specimen Collection Swab, Reagent Capsule
- Flu Testing Device - Preferred Cassette format with on-board extraction well
- Reagent Capsule - Single use one step reagent capsule
- External controls - 1 positive, 1 negative control swab provided in each box
- Simple testing procedure - Less steps required compared to other COID-19/Flu testing platforms
- FDA Emergency Use Authorization (EUA)
CPT Code Information:
- Influenza A: 87804QW
- Influenza B: 87804QW-59
- COVID-19: 87811Q
FAQ:
Is this an antigen or antibody test?
The Status COVID-19/Flu A&B test is an antigen test, using the preferred nasopharyngeal specimen collection.
What is the item number and contents?
Item number 33225; 25 test cassettes, 25 specimen collection swabs, 25 reagent capsules, 1 pos/1neg control swabs.
What is the expiration dating?
Currently six months from date of manufacturing.
What CPT code should be used?
There are CPT codes assigned for both COVID-19 and Flu A&B. COVID-19: 87811QW, Flu A: 87804QW, Flu B: 87804QW-59. As the manufacturer, we cannot guarantee reimbursement values or standard billing procedures.
Is the Status COVID-19/Flu A&B test CLIA Waived?
Through the EUA approval process the FDA authorizes tests for use at the point of care (including COVID-19) under an EUA, such tests are deemed to be CLIA waived tests. Accordingly, for the duration of the emergency declaration, such tests can be performed in a patient care setting that is qualified to have the test performed there as a result of operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Covid Attributes: Type: Antigen / Rapid
Use: Lab / Clinical
Certification: CLIA Certificate Required for purchase
Sample SpecimenType: Nasal Swab
Availability: Ready to ship (typically ships within 7 days)
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