Comparison |
| CLIA Classification |
| CLIA Waived | CLIA Waived | CLIA Moderate Complexity with Nasopharyngeal Wash / Aspirate Samples, CLIA Waived with Nasal / Nasopharyngeal Swabs | CLIA Waived |
| CLIA Classified |
CLIA Waived | CLIA Waived | CLIA Waived | CLIA Waived Sample Dependent | CLIA Waived |
| Contents 1 |
Each Kit has: (4) Test Devices, (4) Sterile Swabs, (4) Extraction Tubes with Buffers and Tips, Instructions for Use | (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 | Test Cassettes, Sterile Swabs, Extraction Reagent Capsules, Positive Control Swab, Negative Control Swab, Package Insert, Procedure Card | (25) Test Cassettes, (25) Sterile Swabs, (25) Extraction Reagent Capsules, Positive Control, Negative Control, Instructions for Use, Procedure Card |
| Country of Origin |
China | China | China | United States | United States |
| 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 |
800 Tests | 25 Tests | 50 Tests | 25 Tests | 25 Tests |
| Product Dating |
| 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 | Throat / Tonsil Saliva Sample | Throat / Tonsil Saliva Sample | Nasal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample | Throat / Tonsil Saliva Sample |
| Test Format |
Cassette Format | Dipstick Format | Dipstick Format | Cassette Format | Cassette Format |
| Test Method |
Lateral Flow Chromatographic Immunoassay | | | | Lateral Flow Method |
| Test Name |
At-Home OTC COVID-19 Test | Strep A Test | Strep A Test | Influenza A + B | Strep A Test |
| Test Type |
Antigen Detection | Infectious Disease Immunoassay | Infectious Disease Immunoassay | Infectious Disease Immunoassay | Infectious Disease Immunoassay |
| Time to Results |
15 Minute Results | 5 Minute Results | 5 Minute Results | 10 to 15 Minute Results | 5 Minute Results |
| UNSPSC Code |
41116144 | 41116129 | 41116129 | 41116144 | 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 |
- The CLINITEST® Rapid COVID-19 Antigen Self-Test is only for use under the Food and Drug Administration’s Emergency Use Authorization: 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
- The CLINITEST® At-Home OTC COVID-19 Test is a lateral flow chromatographic immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2
- This test is authorized for non-prescription home use with self-collected anterior nasal (nares) swab samples from individuals aged 14 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
- This test is also authorized for non-prescription home use with adult-collected anterior nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
- Results are for the identification of SARS-CoV-2 nucleocapsid protein antigen; antigen is generally detectable in anterior nasal (nares) swabs during the acute phase of infection
- Positive results indicate the presence of viral antigens, 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
- Individuals who test positive with CLINITEST® Rapid COVID-19 Antigen Self-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 and confirmation with a molecular assay, if necessary, for patient management, may be performed
- Negative results 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
- Individuals should provide all results obtained with this product to their healthcare provider for public health reporting
- With the CLINITEST® Rapid COVID-19 Antigen Self-Test, you can expect accurate and reliable results in just 15 minutes
- 200 4pk kits in a case or 800 total tests
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- McKesson Consult™ Strep A Dipstick Test
- A rapid test for the qualitative detection of Strep A antigen in throat swab specimens
- CLIA waived and easy to use
- Contents: 25 Dipsticks (in sealed pouches), Disposable extraction test tubes, Sterile swabs, Reagent 1 (10 mL; 2M Sodium Nitrite), Reagent 2 (10 mL; 0.2M Acetic Acid), Positive control (1 mL; Non-viable Strep A; 0.09% NaN3), Negative control (1 mL; Non-viable Strep C; 0.09% NaN3), Instructional insert, Workstations
- Results in five minutes
- Accurate – 97% sensitivity and 95% specificity
- 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
|
- McKesson Consult™ Strep A Dipstick Test
- A rapid test for the qualitative detection of Strep A antigen in throat swab specimens
- CLIA waived and easy to use
- Contents: 50 Dipsticks (2 vials of 25), Disposable extraction test tubes, Sterile swabs, Reagent 1 (10 mL; 2M Sodium Nitrite), Reagent 2 (10 mL; 0.2M Acetic Acid), Positive control (1 mL; Non-viable Strep A; 0.09% NaN3), Negative control (1 mL; Non-viable Strep C; 0.09% NaN3), Instructional insert, Workstations.
- Results in five minutes.
- Accurate – 97% sensitivity and 95% specificity
- 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
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- McKesson Consult™ Influenza A & B Tests
- 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
- CONTENTS: 25 Test Cassettes, 25 Sterile Swabs, 25 Extraction Reagent Capsules, 1 Positive Control Swab, 1 Negative Control Swab, 1 Procedure Card, 1 Instructions for Use
- 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
|
- McKesson Consult™ Strep A Test Kit
- 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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