Comparison |
| CLIA Classification |
CLIA Moderate Complexity | CLIA Non-Waived | CLIA Waived for Fingerstick Whole Blood / CLIA Moderate Complexity for Venous Whole Blood, Serum, Plasma | CLIA Waived | CLIA Waived |
| CLIA Classified |
CLIA Non-Waived | CLIA Non-Waived | CLIA Waived Sample Dependent | CLIA Waived | CLIA Waived |
| Contents 1 |
(20) Individually Packaged Swabs, AmnioTest™ Colour Card, Product Instructions for Use | (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 Cards, Chase Buffer, Package Insert, Quick Reference Guide, (25) Capillary Tubes, (25) Disposable Workstations | (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 |
| Country of Origin |
Unknown | Unknown | United States | United States | United States |
| For Use With |
For Detecting Rupture of Amniotic Membrane in Pregnant Women | | | | |
| Number of Tests |
20 Tests | 24 Tests | 25 Tests | 25 Tests | 25 Tests |
| Product Dating |
McKesson Acceptable Dating: we will ship >= 60 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 >= 90 days |
| Sample Type |
Upper Vaginal Tissue Sample | Vaginal Secretion Sample | Whole Blood / Serum / Plasma Sample | Endocervical Sample | Vaginal Secretion Sample |
| Specialty |
Chemistry | Microbiology | Immunoassay | Microbiology | Immunoassay |
| Storage Requirements |
| Requires Refrigeration | | Requires Refrigeration | |
| Technology |
| | Lateral Flow | | |
| Test Format |
Test Swab Format | Test Card Format | Test Card Format | Tube Format | Dipstick Format |
| Test Kit Type |
Rapid | Standard | Rapid | Rapid | Rapid |
| Test Method |
| | Lateral Flow Method | | |
| Test Name |
Amniotic Fluid Test | Candida Species / Gardnerella Vaginalis / Trichomonas Vaginalis | HIV-1/2 Ag/Ab Combo | Bacterial Vaginosis (BV) | Trichomonas Vaginalis |
| Test Type |
General Chemistry | Microbial Identification | Antibody / Antigen Test | Enzyme Activity Test | Infectious Disease Immunoassay |
| Time to Results |
15 Second Results | 45 Minute Results | 20 Minute Results | 10 Minute Results | 10 Minute Results |
| UNSPSC Code |
41116104 | 41116129 | 41116144 | 41116129 | 41116129 |
| 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 |
- AmnioTest™ assists in the detection of fetal membrane rupture
- Sterile, disposable swabs impregnated with nitrazine yellow dye change color to indicate pH level
- Each AmnioTest™ is packed individually in peel-pouches and sterilized by gamma irradiation
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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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- 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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- 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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