Product Comparison


 
Quidel 20374
McKesson Brand 5001
McKesson Brand 5003
McKesson Brand 5000
McKesson Brand 181-36025
McKesson # 1166253 949871 951316 951311 1076728
Description Rapid Test Kit Sofia® Fluorescence Immunoassay (FIA) SARS Antigen FIA Nasal Swab / Nasopharyngeal Swab Sample 25 Tests Rapid Test Kit McKesson Consult™ Fertility Test hCG Pregnancy Test Urine Sample 25 Tests CLIA Waived Rapid Test Kit McKesson Consult™ Infectious Disease Immunoassay Strep A Test Throat / Tonsil Saliva Sample 25 Tests CLIA Waived Rapid Test Kit McKesson Consult™ Fertility Test hCG Pregnancy Test Urine Sample 25 Tests CLIA Waived Rapid Test Kit McKesson Consult™ Infectious Disease Immunoassay Influenza A + B Nasal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample 25 Tests CLIA Waived
Manufacturer # 20374500150035000181-36025
Brand Sofia®McKesson Consult™McKesson Consult™McKesson Consult™McKesson Consult™
Manufacturer QuidelMcKesson BrandMcKesson BrandMcKesson BrandMcKesson Brand
Invoice TEST KIT, SOFIA 2 SARS ANTIGEN FIA (25TESTS/KT 12KT/CS)TEST KIT, PREG HCG CASSETTE WAIVED (25/KT)TEST, KIT STREP A DIPSTICK WAIVED (25/KT)TEST KIT, PREGNANCY HCG DIPSTICK (25/KT)TEST KIT, INFLUENZA A & B CONSULT CLIA WAIVED (25TEST/KIT)
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Comparison

CLIA Classification CLIA WaivedCLIA WaivedCLIA WaivedCLIA Waived
Contents 1 (25) Individually Packaged Test Cassettes, (25) Reagent Tubes, (25) Ampoules of Reagent Solution, (25) Sterile Nasal Swabs, (25) X 120 µL Fixed Volume Pipettes, Positive Control Swab, Negative Control Swab, Package Insert, Quick Reference Instructions, QC Card(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 InsertTest Cassettes, Sterile Swabs, Extraction Reagent Capsules, Positive Control Swab, Negative Control Swab, Package Insert, Procedure Card
Country of Origin United StatesChinaChinaChinaUnited States
For Use With For use with Sofia / Sofia 2 InstrumentFor Consult® hCG Urine Control Solution, Positive and Negative
Latex Free Indicator Not Made with Natural Rubber LatexNot Made with Natural Rubber LatexNot Made with Natural Rubber LatexNot Made with Natural Rubber Latex
Product Dating McKesson Acceptable Dating: we will ship >= 30 daysMcKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 90 days
Reading Type Machine ReadVisual ReadVisual ReadVisual ReadVisual Read
Sample Type Nasal Swab / Nasopharyngeal Swab SampleUrine SampleThroat / Tonsil Saliva SampleUrine SampleNasal Swab / Nasopharyngeal Wash / Nasopharyngeal Aspirate Sample
Strength 25 mIU / mL Cutoff
Technology Immunofluorescent Sandwich Assay
Test Format Cassette FormatCassette FormatDipstick FormatDipstick FormatCassette Format
Test Method One-Step
Test Name SARS Antigen FIAhCG Pregnancy TestStrep A TesthCG Pregnancy TestInfluenza A + B
Test Type Fluorescence Immunoassay (FIA)Fertility TestInfectious Disease ImmunoassayFertility TestInfectious Disease Immunoassay
Time to Results 15 Minute Results3 Minute Results5 Minute Results3 Minute Results10 to 15 Minute Results
UNSPSC Code 4111620541116136411161294111613641116144
Application Rapid Test KitRapid Test KitRapid Test KitRapid Test KitRapid Test Kit
Number of Tests 25 Tests25 Tests25 Tests25 Tests25 Tests
Features and Benefits
  • Sofia® SARS Antigen FIA test is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Product ships with minimum 30 days dating
  • 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
  • This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation
  • The SARS Antigen FIA does not differentiate between SARS-CoV and SARS-CoV-2
  • 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; the agent detected may not be the definite cause of disease
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • Negative results do not rule out COVID-19 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
  • Rapid results in 15 minutes to support efficient dispositioning of patients
  • Objective, accurate results without cross-reactivity to seasonal coronaviruses
  • The Sofia SARS Antigen FIA is a lateral flow immunofluorescent sandwich assay that is used with the Sofia and Sofia 2 instrument
  • Seamless test workflow follows a similar format to CLIA-waived Sofia and Sofia 2 assays
  • Dual work modes adjust to volume fluctuations and allows for significant throughput and batching of samples in READ NOW Mode
  • Fluorescent technology with automated read eliminates the subjectivity of a visual result
  • Virena provides automated tracking, data capture, government reporting, and exclusive disease mapping
  • All necessary components included in kit, ready for use for nasal swab procedure
  • Self-contained Test Cassette that is clean, easy to use and dispose of
  • For in vitro diagnostic use; RX only
  • 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