Comparison |
| Application |
Respiratory Test Kit | Reproductive Health Test Kit | Respiratory Test Kit | Reproductive Health Test Kit | Respiratory Test Kit |
| CLIA Classification |
CLIA Waived for Direct Nasal Swab, Nasopharyngeal Swab, Nasopharyngeal Aspirate Samples / CLIA Moderate Complexity for Nasopharyngeal Swab, Nasopharyngeal Aspirate Samples Eluted in Transport Media | CLIA Waived | CLIA Waived | CLIA Waived | CLIA Waived |
| CLIA Classified |
CLIA Waived Sample Dependent | CLIA Waived | CLIA Waived | CLIA Waived | CLIA Waived |
| Contents 1 |
(25) Test Cassettes, (25) Reagent Tubes, (25) Reagent Solution, (25) Nasal Swabs, (25) Large Pipettes, (25) Small Pipettes, Positive Control Swab, Negative Control Swab, Printer Paper, Package Insert | (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 |
United States | China | China | China | United States |
| Cutoff |
| | | 25 mIU / mL Cutoff | |
| For Use With |
For Sofia® or Sofia 2® Flourescent Immunoassay Analyzer | | | For Consult® hCG Urine Control Solution, Positive and Negative | |
| 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 |
| Reading Type |
Machine Read | Visual Read | Visual Read | Visual Read | Visual Read |
| Sample Type |
Nasal Swab / Nasopharyngeal Swab / Nasal Wash / Nasal Aspirate 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 |
| One-Step | | | |
| Test Name |
Influenza A + B | hCG Pregnancy Test | Strep A Test | hCG Pregnancy Test | Influenza A + B |
| Test Type |
Fluorescence Immunoassay (FIA) | Fertility Test | Infectious Disease Immunoassay | Fertility Test | Infectious Disease Immunoassay |
| Time to Results |
3 to 15 Minute Results | 3 Minute Results | 5 Minute Results | 3 Minute Results | 10 to 15 Minute Results |
| UNSPSC Code |
41116144 | 41116136 | 41116129 | 41116136 | 41116144 |
| Number of Tests |
25 Tests | 25 Tests | 25 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 | McKesson Acceptable Dating: we will ship >= 90 days |
| Purchase Program Type |
Standard Purchase | Standard Purchase | Standard Purchase | Standard Purchase | Standard Purchase |
| Test Kit Type |
Rapid | Rapid | Rapid | Rapid | Rapid |
| Features and Benefits |
- Requires Sofia or Sofia2 Analyzer (not included) - please see 1058938 and 1087517
- The Sofia Influenza A+B FIA employs immunofluorescence to detect influenza A and influenza B viral nucleoprotein antigens in nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash specimens taken directly from symptomatic patients
- All components included in the kit
- Compatible with RSV Extraction Reagent means when testing with Sofia Influenza A+B FIA, a single patient sample may also be used to test with Sofia RSV FIA
- Fixed volume pipette collects and dispenses correct amount of sample needed for testing
- Room temperature storage
- Product should be kept in temperature between 59 to 86 degrees
|
- 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
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