iHealth COVID-19/Flu A&B Rapid Test Pro (25 tests per kit, Point of Care only)
$187.50 – $200
*Free Next Day Air when you buy 5 or more kits!
Note: Free shipping applies only to 48 contiguous USA states. Additional fees may be required for Hawaii, Alaska, Puerto Rico and other outlying areas.
1-9 kits – $200.00 each
10+ kits – $187.50 each
*Item is NOT for Resale and I must provide a valid CLIA License number in order to purchase the item.
Quantity
KEY FEATURES
FDA AUTHORIZED 15-MINUTE FLU A&B, COVID TEST KIT
This antigen rapid test kit is FDA authorized and designed for use in point-of-care settings, enabling healthcare providers to make quick and informed decisions in just 15 minutes.
EASY-TO-FOLLOW 4 STEPS; GET 3 RESULTS IN 1 TEST
This fully integrated test kit features a straightforward process. By following the 4 user-friendly steps, you can obtain results for COVID-19 and Flu A&B simultaneously with just 5 drops of sample.
LONG SHELF LIFE
The COVID and flu test kit offers a 14-month shelf life, ensuring it remains effctive and ready for use over an extended period.
ROOM TEMPERATURE STORAGE
The test kit is designed for convenient storage at room temperature, eliminating the need for refrigeration and simplifying logistics.
MADE FOR AGES 2 AND ABOVE
With a non-invasive swab, this test kit is suitable for anyone aged 2 years and older, making it a versatile option for testing across di erent age groups.
DESCRIPTION
The iHealth® COVID-19/Flu A&B Rapid Test Pro is a lateral flow immunochromatographic assay intended for in vitro rapid, simultaneous qualitative detection and differentiation of influenza A and influenza B nucleoprotein antigens and SARS-CoV-2 nucleocapsid antigen directly from anterior nasal swab specimens of individuals with signs and symptoms of respiratory infection consistent with COVID-19 by their healthcare provider within the first four (4) days of symptom onset when tested at least twice over three days with at least 48 hours between tests. Clinical signs and symptoms of respiratory viral infection due to SARS-CoV-2 and influenza can be similar. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, that meet the requirements to perform moderate, high or waived complexity tests.
This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
KIT COMPONENTS
| 25 Tests Kit | |
|---|---|
| COVID-19/Flu A&B Test Cards | 27 ea/box* |
| Nasal Swabs | 25 ea/box |
| Tubes | 27 ea/box |
| Quick Reference Instructions | 1 ea/box |
| COVID-19/Flu A&B Positive Control Swab | 1 ea/box |
| COVID-19/Flu A&B Negative Control Swab | 1 ea/box |
| Tube Holder | 1 ea/box |
| *NOTE: Two extra test cards and tubes have been included in the kit for external quality control (QC) testing. | |
| 25 Tests Kit | 40 Tests Kit | |
|---|---|---|
| COVID-19/Flu A&B Test Cards | 27 ea/box* | 42 ea/box* |
| Nasal Swabs | 25 ea/box | 40 ea/box |
| Tubes | 27 ea/box | 42 ea/box |
| Quick Reference Instructions | 1 ea/box | 1 ea/box |
| COVID-19/Flu A&B Positive Control Swab | 1 ea/box | 1 ea/box |
| COVID-19/Flu A&B Negative Control Swab | 1 ea/box | 1 ea/box |
| Tube Holder | 1 ea/box | 1 ea/box |
| *NOTE: Two extra test cards and tubes have been included in the kit for external quality control (QC) testing. | ||
SPECIFICATIONS
- 12 Packs/Carton, 25 Tests/Pack
| UPC # | 850044118656 |
|---|---|
| SKU # | COV-FLU-P-25 |
| Model # | ICF-3000P |
| Packs Per Carton | 12 |
| Tests Per Pack | 25 |
| Single Package Dimensions (LxWxH) | 6.30 x 5.31 x 4.45 Inches |
| Single Package Weight(lb) | 0.97 |
| Carton Dimension (LxWxH) | 19.7 x 11.6 x 10.0 Inches |
| Carton Weight (lb) | 10.6 |
- 6 Packs/Carton, 40 Tests/Pack
| UPC # | 850044118663 |
|---|---|
| SKU # | COV-FLU-P-40 |
| Model # | ICF-3000P |
| Packs Per Carton | 6 |
| Tests Per Pack | 40 |
| Single Package Dimensions (LxWxH) | 8.98 x 8.19 x 3.57 Inches |
| Single Package Weight(lb) | 1.50 |
| Carton Dimension (LxWxH) | 18.9 x 8.9 x 11.9 Inches |
| Carton Weight (lb) | 13.7 |
CLINICAL PERFORMANCE
- SARS-COV-2 PERFORMANCE
| iHealth® | Comparator Method | ||
|---|---|---|---|
| COVID-19/Flu A&B Rapid Test Pro | Positive | Negative | Total |
| Positive | 80 | 7 | 87 |
| Negative | 15 | 435 | 450 |
| Total | 95 | 442 | 537 |
| Positive Agreement (PPA): 80/95 84.2% (95% CI: 75.6%~90.2%) | |||
| Negative Agreement (NPA): 435/442 98.4% (95% CI: 96.8%~99.2%) | |||
- INFLUENZA A PERFORMANCE
| iHealth® | Comparator Method | ||
|---|---|---|---|
| COVID-19/Flu A&B Rapid Test Pro | Positive | Negative | Total |
| Positive | 84 | 1 | 85 |
| Negative | 19 | 431 | 450 |
| Total | 103 | 432 | 535 |
| Positive Agreement (PPA): 84/103 81.6% (95% CI: 73.0%~87.9%) | |||
| Negative Agreement (NPA): 431/432 99.8% (95% CI: 98.7%~100.0%) | |||
- INFLUENZA B PERFORMANCE
| iHealth® | Comparator Method | ||
|---|---|---|---|
| COVID-19/Flu A&B Rapid Test Pro | Positive | Negative | Total |
| Positive | 47 | 1 | 48 |
| Negative | 10 | 477 | 487 |
| Total | 57 | 478 | 535 |
| Positive Agreement (PPA): 47/57 82.5% (95% CI: 70.6%~90.2%) | |||
| Negative Agreement (NPA): 477/478 99.8% (95% CI: 98.8%~100.0%) | |||
Downloadable Resources
FDA EUA Letter
Instructions for Use
Fact Sheet for Healthcare Providers
Fact Sheet for Patients
