iHealth® Flu A & B/COVID-19/RSV Rapid Test Pro (25 tests per kit, For professional use)
Seasonal Promotion! (Limited Time Only)
$212.50 – $237.50
*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 – $237.50 each
10+ kits – $212.50 each
*Item is NOT for Resale and I must provide a valid CLIA License number in order to purchase the item.
Quantity
KEY FEATURES
15-MINUTE FLU A&B, COVID, and RSV TEST KIT
This antigen rapid test kit is FDA 510(K) cleared and can be used in CLIA waiver settings, enabling healthcare providers to make quick and informed decisions in just 15 minutes.
EASY-TO-FOLLOW 4 STEPS; GET 4 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, Flu A&B and RSV simultaneously with just 5 drops of sample.
LONG SHELF LIFE
The COVID, flu and RSV test kit offers a 15-month shelf life.
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 6 MONTHS AND ABOVE
With a non-invasive swab, this test kit is suitable for anyone aged 6 months and older, making it a versatile option for testing across different age groups.
DESCRIPTION
The iHealth Flu A&B/COVID-19/RSV Rapid Test Pro is a lateral flow immunochromatographic assay intended for the qualitative detection and differentiation of influenza A, influenza B, SARS-CoV-2, and respiratory syncytial virus (RSV) protein antigens directly in anterior nasal swab samples from individuals with signs and symptoms of respiratory tract infection. Symptoms of respiratory infections due to influenza, SARS-CoV-2, and RSV can be similar. This test is for use by individuals aged 14 years or older testing themselves, or adults testing individuals aged six (6) months or older.
All negative results are presumptive and should be confirmed with an FDA-cleared molecular assay when determined to be appropriate by a healthcare provider. Negative results do not rule out infection with influenza, SARS-CoV-2, RSV, or other pathogens. Individuals who test negative and/or experience continued or worsening respiratory symptoms, such as fever, cough and/or shortness of breath, should seek follow-up care from their healthcare provider. Positive results do not rule out co-infection with other respiratory pathogens. Test results should not be used as the sole basis for treatment or other patient management decisions.
KIT COMPONENTS
| Kit components | Quantity |
|---|---|
| 25 Tests Kit | |
| Flu A&B/COVID-19/RSV Test Cards | 25 ea/box |
| Nasal Swabs | 25 ea/box |
| Extraction Buffer Tube(s) | 25 ea/box |
| Quick Reference Instructions | 1 ea/box |
| Tube Holder | 1 ea/box |
| 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
- 25 Tests/Kit
| UPC # | UPC: 850078377166 |
| SKU # | CFR-P-25 |
| Model # | Model#: ICR-3000P |
| Packs Per Carton | 12 |
| Tests Per Kit | 25 |
| Single Package Dimensions (LxWxH) | 6.30 × 5.31 × 4.45 in |
| Single Package Weight(lb) | 1.083 lb |
| Carton Dimension (LxWxH) | 19.69 × 11.61 × 10.04 in |
| Carton Weight (lb) | 13 lbs |
- 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
| SARS-CoV-2 | Comparator Positives | Comparator Negatives | Sum |
|---|---|---|---|
| Investigational Positives | 67 | 1 | 68 |
| Investigational Negatives | 8 | 1043 | 1051 |
| Sum | 75 | 1044 | 1119 |
| Positive Percent Agreement = (67/75) = 89.3% (95% CI: 80.3%- 94.5%) | |||
| Negative Percent Agreement = (1043/1044) = 99.9% (95% CI: 99.5%- 100.0%) | |||
- INFLUENZA A PERFORMANCE
| FLU A | Comparators Positives | Comparators Negatives | Sum |
|---|---|---|---|
| Investigational Positives | 205 | 4 | 209 |
| Investigational Negatives | 29 | 881 | 910 |
| Sum | 234 | 885 | 1119 |
| Positive Percent Agreement = (205/234) = 87.6% (95% CI: 82.8% - 91.2%) | |||
| Negative Percent Agreement = (881/885) = 99.5% (95% CI: 98.8%- 99.8%) | |||
- INFLUENZA B PERFORMANCE
| FLU B | Comparators Positives | Comparators Negatives | Sum |
|---|---|---|---|
| Investigational Positives | 36 | 0 | 36 |
| Investigational Negatives | 3 | 1080 | 1083 |
| Sum | 39 | 1080 | 1119 |
| Positive Percent Agreement = (36/39) = 92.3% (95% CI: 79.7% - 97.3%) | |||
| Negative Percent Agreement = (1080/1080) = 100.0% (95% CI: 99.6% - 100.0%) | |||
- RSV PERFORMANCE
| RSV | Comparators Positives | Comparators Negatives | Sum |
|---|---|---|---|
| Investigational Positives | 149 | 12 | 161 |
| Investigational Negatives | 21 | 937 | 958 |
| Sum | 170 | 949 | 1119 |
| Positive Percent Agreement = (149/170) = 87.6% (95% CI: 81.9% - 91.8%) | |||
| Negative Percent Agreement = (937/949) = 98.7% (95% CI: 97.8% - 99.3%) | |||
Downloadable Resources
FDA 510(k) Clearance Letter
Instructions for Use
FDA Decision Summary
