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 |
(25) Single Use Test Devices, (2) Bottles of 9 mL Extraction Solution, (25) Single Use Tubes, (25) Single Use Dropper Tips, (25) Single Use Anterior Nasal Specimen Sampling Swabs, Single Use External Positive Control, Single Use External Negative Control, IFU, Quick Reference Instructions |
(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 |
South Korea |
Unknown |
Unknown |
Unknown |
United States |
Cutoff |
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25 mIU / mL Cutoff |
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For Use With |
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For Consult® hCG Urine Control Solution, Positive and Negative |
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HCPCS |
U0002 |
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Latex Free Indicator |
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Not Made with Natural Rubber Latex |
Not Made with Natural Rubber Latex |
Not Made with Natural Rubber Latex |
Not Made with Natural Rubber Latex |
Product Dating |
McKesson Acceptable Dating: we will ship >= 30 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 |
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 Immunoassay |
One-Step |
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|
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Test Name |
COVID-19 Ag) |
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 |
15 Minute Results |
3 Minute Results |
5 Minute Results |
3 Minute Results |
10 to 15 Minute Results |
UNSPSC Code |
41116205 |
41116136 |
41116129 |
41116136 |
41116144 |
CLIA Classified |
CLIA Waived |
CLIA Waived |
CLIA Waived |
CLIA Waived |
CLIA Waived |
Number of Tests |
25 Tests |
25 Tests |
25 Tests |
25 Tests |
25 Tests |
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 GenBody COVID-19 Ag Test if for use under an FDA 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
- Ships with minimum 30 Days Dating
- The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in Anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset, or from individuals 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 48 hours between tests
- 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
- 这个测试被授权使用的Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation
- Positive results indicate the presence of viral antigens, but clinical correlation with patient 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
- Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
- Negative results should be treated as presumptive and may be confirmed with a molecular assay, if necessary, for patient management
- 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
- Negative results should be considered in the context of a patient’s recent exposures, history, and the presence of clinical signs and symptoms consistent with COVID-19
- The GenBody COVID-19 Ag is intended for use by medical professionals or operators trained in performing tests in point of care settings
- GenBody COVID-19 Ag test allows for near patient testing without the need for instrumentation or special equipment
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- 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
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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
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- 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
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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
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