Product Comparison


  Abbott Rapid Dx North America LLC 7D2648 BD 446252 Sekisui Diagnostics 183 Chembio Diagnostic 60-9505-1 Sekisui Diagnostics 181
McKesson # 875804 365609 548464 944100 548463
Description Sexual Health Test Kit Determine™ HIV-1/2 Ag/Ab Combo 25 Tests CLIA Waived Sample Dependent Sexual Health Test Kit BD Affirm™ VPIII Candida Species / Gardnerella Vaginalis / Trichomonas Vaginalis 24 Tests CLIA Non-Waived Sexual Health Test Kit OSOM® BVBLUE® Bacterial Vaginosis (BV) 25 Tests CLIA Waived Sexual Health Test Kit STAT-PAK® HIV-1/2 20 Tests CLIA Waived Sample Dependent Sexual Health Test Kit OSOM® Trichomonas Vaginalis 25 Tests CLIA Waived
Manufacturer # 7D264844625218360-9505-1181
Brand Determine™BD Affirm™ VPIIIOSOM® BVBLUE®STAT-PAK®OSOM®
Manufacturer Abbott Rapid Dx North America LLCBDSekisui DiagnosticsChembio DiagnosticSekisui Diagnostics
Invoice TEST, DETERMINE HIV-1/2 AG/ABWAIVED (25/KT)TEST KIT, AFFIRM VPIII (24/KT)TEST KIT, OSOM BACTERIAL VAGINOSIS (25/KT 5KT/CS)STAT-PAK, HIV 1/2 ASSAY 20TST FINGER STICK RAPID TESTTEST KIT, TRICHOMONAS RAPID (25/KT 6KT/CS) GENZME
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Comparison

CLIA Classification CLIA Waived for Fingerstick Whole Blood / CLIA Moderate Complexity for Venous Whole Blood, Serum, PlasmaCLIA Non-WaivedCLIA WaivedCLIA Waived for Whole BloodCLIA Waived
CLIA Classified CLIA Waived Sample DependentCLIA Non-WaivedCLIA WaivedCLIA Waived Sample DependentCLIA Waived
Contents 1 (25) Test Cards, Chase Buffer, Package Insert, Quick Reference Guide, (25) Capillary Tubes, (25) Disposable Workstations(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) Test Vessels, Bottle Developer Solution, Sterile Swabs, Directional Insert(20) Stat-Pak® Test Devices, (20) Sample Loops, Running Buffer, Quick Reference Instructions, (20) Subject Information Notices, Product Insert(25) Test Sticks, (25) Sterile Swabs, (25) Test Tubes, 25 mL Sample Buffer, Sample Buffer Dropper Top, Positive Control Swab, Workstation, Directional Insert, Extra Swabs and Tubes also Provided
Country of Origin United StatesUnknownUnited StatesUnknownUnited States
HCPCS G0435
Number of Tests 25 Tests24 Tests25 Tests20 Tests25 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 60 daysMcKesson Acceptable Dating: we will ship >= 90 daysMcKesson Acceptable Dating: we will ship >= 60 daysMcKesson Acceptable Dating: we will ship >= 90 days
Sample Type Whole Blood / Serum / Plasma SampleVaginal Secretion SampleEndocervical SampleWhole Blood / Serum / Plasma SampleVaginal Secretion Sample
Specialty ImmunoassayMicrobiologyMicrobiologyImmunoassayImmunoassay
Storage Requirements Requires RefrigerationRequires Refrigeration
Technology Lateral Flow
Test Format Test Card FormatTest Card FormatTube FormatCassette FormatDipstick Format
Test Kit Type RapidStandardRapidRapidRapid
Test Method Lateral Flow Method
Test Name HIV-1/2 Ag/Ab ComboCandida Species / Gardnerella Vaginalis / Trichomonas VaginalisBacterial Vaginosis (BV)HIV-1/2Trichomonas Vaginalis
Test Type Antibody / Antigen TestMicrobial IdentificationEnzyme Activity TestAntibody TestInfectious Disease Immunoassay
Time to Results 20 Minute Results45 Minute Results10 Minute Results15 Minute Results10 Minute Results
UNSPSC Code 4111614441116129411161294111614441116129
Application Sexual Health Test KitSexual Health Test KitSexual Health Test KitSexual Health Test KitSexual Health Test Kit
Purchase Program Type Standard PurchaseStandard PurchaseStandard PurchaseStandard PurchaseStandard Purchase
Reading Type Visual ReadVisual ReadVisual ReadVisual ReadVisual Read
Features and Benefits
  • Innovative: The first and only FDA cleared point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen on single test strip
  • CLIA Waived (Fingerstick Collection): 3 easy steps and minimal training to allow testing across a range of test sites
  • Proven: 99.9% overall clinical sensitivity for all sample types
  • Rapid: Results in just 20 minutes
  • Flexible Sample Types: Test using capillary and venous whole blood, serum, and plasma
  • Each test strip has a cover that is to be removed for sample application and visualization of test results
  • 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
  • Detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus
  • HIV 1/2 STAT-PAK® Sample Pack is a qualitative screening test kit for the detection fo antibodies to HIV-1 and HIV-2 in serum, plasma, or whole blood
  • HIV 1/2 STAT-PAK® delivers rapid results in 15 minutes
  • Minimal sample size of 5µL
  • Room temperature storage
  • Kit includes: 20 individually pouched HIV 1/2 Test Devices, 20 Disposable 5 µL Sample Loops, 1 HIV Running Buffer (3.5 mL)
  • Documentation included: 20 copies of Subject Information Notice, 1 Quick Reference Instructions (for CLIA Waived), 1 Product Insert
  • For use with control 944103 (catalog #60-9549-0)
  • The OSOM® Trichomonas Rapid Test is intended for the qualitative detection of Trichomonas vaginalis (Trichomona) antigens from vaginal swabs or from the saline solution prepared when making wet mounts from vaginal swabs
  • Accurate - 95 percent agreement against composite reference standard (culture and wet mount)
  • Provides easy-to-read two color results
  • Room Temperature Storage - 16 month shelf life
  • The OSOM® Trichomonas Rapid Test is an immunochromatographic assay that detects pathogen antigens directly from vaginal swabs