Comparison |
| Application |
Respiratory Test Kit |
Reproductive Health Test Kit |
Respiratory Test Kit |
Reproductive Health Test Kit |
Respiratory Test Kit |
| CLIA Classification |
|
CLIA Waived |
CLIA Waived |
CLIA Waived |
CLIA Waived |
| Contents 1 |
Each Box contains (2) Test Cassettes, (2) Nasal Swabs, (2) Reagent Vials and (2) Vial Caps |
(25) Cassettes in Sealed Pouches, Disposable Specimen Pipettes, Instructional Insert |
(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 |
(25) Dipsticks in Sealed Pouches, Instructional Insert |
Test Cassettes, Sterile Swabs, Extraction Reagent Capsules, Positive Control Swab, Negative Control Swab, Package Insert, Procedure Card |
| Country of Origin |
Unknown |
Unknown |
Unknown |
Unknown |
United States |
| Cutoff |
|
|
|
25 mIU / mL Cutoff |
|
| For Use With |
For use with iOS / Android Mobile Devices and the On/Go App |
|
|
For Consult® hCG Urine Control Solution, Positive and Negative |
|
| HCPCS |
U0002 |
|
|
|
|
| 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 |
232 Boxes per Case / 2 Tests per Box |
25 Tests |
25 Tests |
25 Tests |
25 Tests |
| Product Dating |
|
McKesson接受蒂ng: we will ship >= 90 days |
McKesson接受蒂ng: we will ship >= 90 days |
McKesson接受蒂ng: we will ship >= 90 days |
McKesson接受蒂ng: we will ship >= 90 days |
| Sample Type |
Nasal Swab Sample |
Urine Sample |
Throat / Tonsil Saliva Sample |
Urine Sample |
Nasal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample |
| Specialty |
Immunoassay |
Chemistry |
Immunoassay |
Chemistry |
Immunoassay |
| Test Format |
Cassette Format |
Cassette Format |
Dipstick Format |
Dipstick Format |
Cassette Format |
| Test Method |
Lateral Flow Chromatographic Immunoassay |
One-Step |
|
|
|
| Test Name |
COVID-19 At-Home Rapid Antigen Test |
hCG Pregnancy Test |
Strep A Test |
hCG Pregnancy Test |
Influenza A + B |
| Test Type |
Antigen Detection |
Fertility Test |
Infectious Disease Immunoassay |
Fertility Test |
Infectious Disease Immunoassay |
| Time to Results |
10 Minute Results |
3 Minute Results |
5 Minute Results |
3 Minute Results |
10 to 15 Minute Results |
| UNSPSC Code |
41116144 |
41116136 |
41116129 |
41116136 |
41116144 |
| CLIA Classified |
CLIA Waived |
CLIA Waived |
CLIA Waived |
CLIA Waived |
CLIA Waived |
| 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 |
| Features and Benefits |
- The on/go™ COVID-19 Antigen Self-Test has not been FDA cleared or approved but has been authorized by FDA under an Emergency Use Authorization (EUA): 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
- Ships with minimum 30 Days Dating
- The on/go™ COVID-19 Antigen Self-Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigens 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 nasal (nares) swab samples from individuals aged 2 years or older with symptoms of COVID-19 within the first 7 days of symptom onset
- 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 and the agent detected may not be the definite cause of disease
- Negative results should be treated as presumptive and confirmation with a molecular assay for patient management, may be performed if necessary; 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
- 检测到所有已知的抗原蛋白主要浸ID-19 variants of concern (including Delta and Omicron)
- Material required but not provided: Smartphone: iOS13 or newer / Android 10 or newer, Mobile App (Prior to testing, the user should download the free mobile application, on/go™ App, for iOS or Android smartphones)
|
- McKesson Consult™ hCG Urine Cassette Test
- A rapid test for the qualitative detection of human chorionic gonadotropin (hCG) in urine.
- CLIA Waived for Urine.
- Contents: 25 Cassettes (in sealed pouches), Disposable specimen pipettes, Instructional insert.
- Positive results in as little as three minutes.
- Urine cassette has a 20 mIU/mL cutoff.
- Greater than 99% accuracy.
- Built-in procedural controls.
- True one-step test.
- 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: 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™ hCG Urine Dipstick Test
- A rapid test for the qualitative detection of human chorionic gonadotropin (hCG) in urine
- CLIA Waived for Urine
- Contents: 25 Dipsticks (in sealed pouches), Instructional insert
- Positive results in as little as three minutes
- Urine dipstick has a 25 mIU/mL cutoff
- Greater than 99% accuracy
- Built-in procedural controls
- True one-step test
- For in vitro diagnostic use only
- 24-month shelf life
- Not made with natural rubber latex.
- Packaged: 25 Tests Per Box
|
- 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
|
