Product Comparison


 
Quidel 97022HS
BD 446252
Quidel 20387
Quidel 98000XR
Abbott Rapid Dx North America LLC 575000
McKesson # 824761 365609 1183198 575746 1087254
Description Test Kit Triage® Cardiac Marker / Immunoassay Creatine Kinase MB / Troponin I Whole Blood / Plasma Sample 25 Tests Test Kit Affirm™ VPIII Microbial Identification Candida Species / Gardnerella Vaginalis / Trichomonas Vaginalis Vaginal Secretion Sample 24 Tests Test Kit QuickVue® Professional Use SARS Antigen Nasal Swab Sample 25 Tests Test Kit Triage® Cardiac Marker / Immunoassay B-Type Natriuretic Peptide (BNP) Whole Blood / Plasma Sample 25 Tests Test Kit BinaxNOW® Influenza A&B Card 2 With Alere™ Reader Interpretation Infectious Disease Immunoassay Influenza A + B Nasal Swab / Nasopharyngeal Swab Sample 22 Tests
Manufacturer # 97022HS4462522038798000XR575000
Brand Triage®Affirm™ VPIIIQuickVue® Professional UseTriage®BinaxNOW® Influenza A&B Card 2 With Alere™ Reader Interpretation
Manufacturer QuidelBDQuidelQuidelAbbott Rapid Dx North America LLC
Invoice TEST KIT, TROPONIN W/CKMB 2X25(25/CT)TEST KIT, AFFIRM VPIII (24/KT)TEST KIT, SARS ANTIGEN QUICKVUE PROFESSIONAL USE (25/KT)TEST KIT, BNP TRIAGE B-TYPE NARIURETICPEPTD25TSTTEST KIT, INFLUENZA ALERE BINAXNOW A & B CARD (22TEST/KT)
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Comparison

CLIA Classification CLIA Moderate ComplexityCLIA Moderate ComplexityCLIA Waived for Whole Blood / CLIA Moderate Complexity for PlasmaCLIA Waived
Contents (25) Test Devices, (25) Transfer Pipettes, Reagent Code Chip Module, Printer Paper Roll(24) Probe Analysis Cards, (24) Reagent Cassettes, 3.4 mL Substrate Solution, 10.8 mL Lysis Solution, 15 mL Buffer Solution, (24) Filter Tips, (24) Sample Collection Cups, (24) Sample Collection Tubes, (24) Sterile Swabs(25) Individually Packaged Test Strips, (25) Reagent Tubes, (25) Vials of Reagent Solution with 340 µL Salt Solution, (25) Sterile Nasal Swabs, SARS Positive Control Swab, Negative Control Swab, Package Insert, and Procedure Card(25) Test Devices, Reagent Code Chip Module, Printer Paper Roll, (25) Pipettes, Package Insert(22) Test Units, Transfer Pipettes, Positive Control Swab, Negative Control Swab, Elution Vials For Controls, Product Insert and Procedure Card
Country of Origin United StatesUnknownUnited StatesUnited StatesUnknown
For Use With For Triage® MeterPro® SystemFor Triage® MeterPro® SystemFor The Alere™ Reader
Number of Tests 25 Tests24 Tests25 Tests25 Tests22 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 60 daysMcKesson Acceptable Dating: we will ship >= 60 daysMcKesson Acceptable Dating: we will ship >= 30 daysMcKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 90 days
Reading Type Machine ReadVisual ReadVisual ReadMachine ReadMachine Read
Sample Type Whole Blood / Plasma SampleVaginal Secretion SampleNasal Swab SampleWhole Blood / Plasma SampleNasal Swab / Nasopharyngeal Swab Sample
Storage Requirements Requires RefrigerationRequires RefrigerationUSP Controlled Room TemperatureRequires Refrigeration
Test Format Cassette FormatTest Card FormatTest Strip FormatCassette FormatTest Card Format
Test Method Fluorescence Immunoassay (FIA)Lateral Flow MethodFluorescence Immunoassay (FIA)Lateral Flow Method
Test Name Creatine Kinase MB / Troponin ICandida Species / Gardnerella Vaginalis / Trichomonas VaginalisSARS AntigenB-type Natriuretic Peptide (BNP)Influenza A + B
Test Type Cardiac Marker / ImmunoassayMicrobial IdentificationCardiac Marker / ImmunoassayInfectious Disease Immunoassay
Time to Results 20 Minute Results45 Minute Results10 Minute Results20 Minute Results15 Minute Results
UNSPSC Code 4111610441116129411161444111610441116144
Application Test KitTest KitTest KitTest KitTest Kit
Features and Benefits
  • Tnl / CKMB on one test device
  • The Affirm™ VPIII Microbial Identification Test is a DNA probe test intended for use in the detection and identification of Candida species, Gardnerella vaginalis and Trichomonas vaginalis nucleic acid in vaginal fluid specimens
  • The test uses two distinct single-stranded nucleic acid probes for each organism, a capture probe and a color development probe, that are complementary to unique genetic sequences of the target organisms
  • The capture probes are immobilized on a bead embedded in a Probe Analysis Card (PAC), which contains a separate bead for each target organism
  • The color development probes are contained in a multi-well Reagent Cassette (RC)
  • Kit includes: 24 Probe Analysis Cards (PAC), 24 Reagent Cassettes (RC), 3.4 mL Substrate Solution, 10.8 mL Lysis Solution, 15 mL Buffer Solution, 24 Filter Tips, 24 Sample Collection Cups, 24 Sample Collection Tubes, 24 Sterile Swabs
  • Individually packaged cards, wrapped in an absorbent paper towel moistened with a solution containing sodium azide (0.1%, w/v) as a preservative
  • Each PAC contains the following five beads: Negative Control, Trichomonas, Gardnerella, Candida, and Positive Control
  • Reagents are sealed in multi-well, foil covered cassettes
  • Each cassette has seven wells
  • All reagents are supplied ready for use
  • For use under an Emergency Use Authorization (EUA) only: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • Product ships from McKesson 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
  • Please see attached letter for detailed information on a 1 year extension on expiration dating
  • The QuickVue SARS Antigen Test is a lateral flow immunoassay that allows for the rapid, qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 in anterior nares (NS) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms
  • The QuickVue SARS Antigen test 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
  • 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 confirmation with a molecular assay, if necessary, for patient management, may be performed; 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
  • The QuickVue SARS Antigen test is intended for use by trained clinical laboratory personnel and individuals trained in point of care settings
  • Accurate detection with direct anterior nares swab samples: 96.6% PPA and 99.3% NPA
  • Simple workflow follows a similar format to CLIA-waved QuickVue assays, just sample, dip, and read
  • Each kit contains everything needed to perform the test, including Nasal Swabs and positive and negative controls
  • The Triage BNP test measures BNP to aid in the diagnosis and assess the severity of congestive heart failure
  • The test is also used for the risk stratification of patients with acute coronary syndromes and patients with heart failure
  • Sensitivity 80.6%, specificity 98%
  • Rapid results in approximately 15 minutes
  • Results read by the Triage meterpro meter
  • Sample Type: whole blood, plasma
  • CLIA Waived for Whole Blood
  • Alere BinaxNOW® Influenza A & B Card 2 MUST be read by the Alere™ Reader
  • The first rapid antigen influenza test to achieve 510(k) clearance as a Class II assay under the new FDA Reclassification performance requirements
  • Alere Reader provides objective result interpretation
  • Used with either nasopharyngeal swab or nasal swab samples
  • Simple, straightforward testing procedure