Comparison |
| CLIA Classification |
CLIA Waived for Fingerstick Whole Blood / CLIA Moderate Complexity for Venous Whole Blood, Serum, Plasma | CLIA Non-Waived | CLIA Waived | CLIA Waived | CLIA Waived for Whole Blood, Saliva / CLIA Moderate Complexity for Plasma |
| CLIA Classified |
CLIA Waived Sample Dependent | CLIA Non-Waived | CLIA Waived | CLIA Waived | CLIA Waived Sample Dependent |
| 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 | (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 | (25) Divided Pouches with Test Device and 1 mL Vial Developer Solution, (5) Reusable Test Stands, (25) Specimen Collection Loops, (25) Information Pamphlets, Package Insert, Customer Letter |
| Country of Origin |
United States | Puerto Rico | United States | United States | United States |
| Number of Tests |
25 Tests | 24 Tests | 25 Tests | 25 Tests | 25 Tests |
| Product Dating |
McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 60 days | McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 90 days | McKesson Acceptable Dating: we will ship >= 180 days |
| Sample Type |
Whole Blood / Serum / Plasma Sample | Vaginal Secretion Sample | Endocervical Sample | Vaginal Secretion Sample | Whole Blood / Plasma / Saliva Sample |
| Specialty |
Immunoassay | Microbiology | Microbiology | Immunoassay | Immunoassay |
| Storage Requirements |
| Requires Refrigeration | Requires Refrigeration | | |
| Technology |
Lateral Flow | | | | |
| Test Format |
Test Card Format | Test Card Format | Tube Format | Dipstick Format | Cassette Format |
| Test Kit Type |
Rapid | Standard | Rapid | Rapid | Rapid |
| Test Method |
Lateral Flow Method | | | | Lateral Flow Method |
| Test Name |
HIV-1/2 Ag/Ab Combo | Candida Species / Gardnerella Vaginalis / Trichomonas Vaginalis | Bacterial Vaginosis (BV) | Trichomonas Vaginalis | HIV-1/2 |
| Test Type |
Antibody / Antigen Test | Microbial Identification | Enzyme Activity Test | Infectious Disease Immunoassay | Antibody Test |
| Time to Results |
20 Minute Results | 45 Minute Results | 10 Minute Results | 10 Minute Results | 20 Minute Results |
| UNSPSC Code |
41116144 | 41116129 | 41116129 | 41116129 | 41116144 |
| Application |
Sexual Health Test Kit | Sexual Health Test Kit | Sexual Health Test Kit | Sexual Health Test Kit | Sexual Health Test Kit |
| 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 |
- 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
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- 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
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- Detects elevated vaginal fluid sialidase activity, an enzyme produced by bacterial pathogens associated with bacterial vaginosis including Gardnerella, Bacteroides, Prevotella and Mobiluncus
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- 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
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- The OraQuick ADVANCE® Rapid HIV-1/2 Antibody Test detects antibodies to HIV-1 and HIV-2 in 20 minutes
- Approved for oral fluid, plasma, fingerstick or venipuncture whole blood specimens
- Complexity: Waived for Oral Fluid, Fingerstick Whole Blood and Venipuncture Whole Blood
- Complexity: Moderate for plasma samples
- The OraQuick ADVANCE® rapid test is comprised of a single-use test device and a single-use vial containing a pre-measured amount of a buffered developer solution
- Each component is sealed in separate compartments of a single pouch to form the test
- An oral fluid specimen is collected using the flat pad on the test device, followed by the insertion of the device into the vial of developer solution
- Store unused, unopened test kits at 2 - 27 degrees C (35 - 80 degrees F)
- WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov
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