Comparison |
| Buy American Act (BAA) Compliant |
Yes | Yes | | | Yes |
| CLIA Classification |
CLIA Waived | CLIA Moderate Complexity for Nasopharyngeal Wash / Aspirate Samples, CLIA Waived for Nasal / Nasopharyngeal Swabs | CLIA Waived | CLIA Waived | CLIA Waived |
| CLIA Classified |
CLIA Waived | CLIA Waived Sample Dependent | CLIA Waived | CLIA Waived | CLIA Waived |
| Contents 1 |
(1) Large Box with (25) Individually Wrapped Sterile Foam Swabs, (25) Test Strips, (25) Pre-filled Tubes, Tube Holder, Instruction Sheet, Fact Sheet for Individuals | (25) Test Cassettes, (25) Sterile Swabs, (25) Extraction Reagent Capsules, (1) Positive Control Swab, (1) Negative Control Swab, Package Insert, Procedure Card | (25) Dipsticks in Sealed Pouches, Disposable Extraction Test Tubes, Sterile Swabs, 10 mL Reagent 1, 10 mL Reagent 2, 1 mL Positive Control, 1 mL Negative Control, Instructional Insert, Workstations | (50) Dipsticks (2 Vials of 25), Disposable Extraction Test Tubes, Sterile Swabs, 10 mL Reagent 1, 10 mL Reagent 2, 1 mL Positive Control, 1 mL Negative Control, Instructional Insert, Workstations | (25) Test Cassettes, (25) Sterile Swabs, (25) Extraction Reagent Capsules, Positive Control, Negative Control, Instructions for Use, Procedure Card |
| Country of Origin |
United States | United States | China | China | United States |
| Is_ECAT |
N | | | | |
| Is_GSA |
Y | | | | |
| Is_VA |
N | | | | |
| Latex Free Indicator |
| Not Made with Natural Rubber Latex | Not Made with Natural Rubber Latex | Not Made with Natural Rubber Latex | Not Made with Natural Rubber Latex |
| Number of Tests |
25 Tests | 25 Tests | 25 Tests | 50 Tests | 25 Tests |
| Product Dating |
McKesson Acceptable Dating: we will ship >= 60 days | McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 90 days |
| Sample Type |
Nasal Swab Sample | Nasal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample | Throat / Tonsil Saliva Sample | Throat / Tonsil Saliva Sample | Throat / Tonsil Saliva Sample |
| Test Format |
Test Strip Format | Cassette Format | Dipstick Format | Dipstick Format | Cassette Format |
| Test Method |
Lateral Flow Immunoassay | | | | Lateral Flow Method |
| Test Name |
At-Home OTC COVID-19 Test | Influenza A + B | Strep A Test | Strep A Test | Strep A Test |
| Test Type |
| Infectious Disease Immunoassay | Infectious Disease Immunoassay | Infectious Disease Immunoassay | Infectious Disease Immunoassay |
| Time to Results |
10 Minute Results | 10 to 15 Minute Results | 5 Minute Results | 5 Minute Results | 5 Minute Results |
| Trade Agreement Act (TAA) Compliant |
Yes | Yes | | | Yes |
| UNSPSC Code |
41116144 | 41116144 | 41116129 | 41116129 | 41116129 |
| Application |
Respiratory Test Kit | Respiratory Test Kit | Respiratory Test Kit | Respiratory Test Kit | Respiratory Test Kit |
| Purchase Program Type |
Standard Purchase | Standard Purchase | Standard Purchase | Standard Purchase | Standard Purchase |
| Reading Type |
Visual Read | Visual Read | Visual Read | Visual Read | Visual Read |
| Specialty |
Immunoassay | Immunoassay | Immunoassay | Immunoassay | Immunoassay |
| Test Kit Type |
Rapid | Rapid | Rapid | Rapid | Rapid |
| Features and Benefits |
- For Use Under an Emergency Use Authorization (EUA) Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas-antigen-diagnostic-tests-sars-cov-2
- Product ships with minimum 30 days dating
- The QuickVue At-Home OTC COVID-19 Test is intended for the qualitative detection of nucleocapsid proteins from SARS-CoV-2 from individuals with or without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 36 hours between tests
- This test is authorized for nonprescription home use with self-collected (unobserved) direct anterior nasal(NS) swab specimens from individuals aged 14 years and older or with adult-collected anterior NS samples from individuals aged 2 years or older
- Positive results indicate the presence of virus-specific proteins, but clinical correlation with past medical history and other diagnostic information is necessary to determine infection status
- Positive results do not rule out bacterial infection or co-infection with other viruses and the agent detected may not be the definite cause of disease. Individuals who test positive with the QuickVue At-Home OTC COVID-19 Test should self-isolate and seek follow-up care with their physician or healthcare provider as additional testing may be necessary
- Negative results should be treated as presumptive, do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
- Negative results should be considered in the context of an individual’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management
- Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
- This product has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens
- The test is intended to be read at 10 minutes; If the test is read before this or is read more than 5 minutes after the indicated read time, results may be inaccurate and the test should be repeated
- In the event of resale: Strict adherence to the adherence to the Conditions Related to Printed Materials, Advertising and Promotion contained in the Emergency Use Authorization (EUA) is required; Minimum Advertised Price of $24.95 must be used
|
- Rapid qualitative test that detects Influenza type A and type B antigens directly from nasal swab, nasopharyngeal swab, and Nasopharyngeal aspirate / wash specimens
- Color-coded control swab packaging for easy positive/negative identification
- Results in under 15 minutes
- CLIA Complexity: Moderate Complexity when used with Nasopharyngeal Wash/Aspirate Samples- CLIA Waived when used with Nasal and Nasopharyngeal Swabs
- For aspirate samples, kit sold separately (MFR#: 181-36026)
- For professional and laboratory use only
- For in vitro diagnostic use only
- Not Made with Natural Rubber Latex
- Packaged: 25 Tests Per Box
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- A rapid test for the qualitative detection of Strep A antigen in throat swab specimens
- Accurate – 97% sensitivity and 95% specificity
- CLIA waived and easy to use
- External positive and negative quality controls provided
- For in vitro diagnostic use only
- 24-month shelf life
- Not Made with Natural Rubber Latex
- Packaged: 25 Tests Per Box
|
- A rapid test for the qualitative detection of Strep A antigen in throat swab specimens
- Accurate – 97% sensitivity and 95% specificity
- Results in five minutes
- CLIA waived and easy to use
- External positive and negative quality controls provided
- For in vitro diagnostic use only
- 24-month shelf life
- Not Made with Natural Rubber Latex
- Packaged: 50 Tests Per Box
|
- A rapid test for the qualitative detection of Strep A antigen in throat swab specimens
- Easy-to-use flip step eliminates need for pipetting
- Fast, accurate detection of Group A Strep with walk-away convenience
- Single use extraction reagent capsules; no counting reagent drops – less steps for greater accuracy
- Color-coded control and test lines on the cassette for easy positive/negative identification
- Rapid results in 5 minutes
- Features a 96.2% level of sensitivity and 98.7% specificity
- CLIA-waived
- For professional and laboratory use only
- For in vitro diagnostic use only
- For single use only
- Not Made with Natural Rubber Latex
- Packaged: 1 Kit Per Pouch, 25 Pouches Per Box
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