Comparison |
| CLIA Classification |
CLIA Moderate Complexity | CLIA Non-Waived | CLIA Moderate Complexity | CLIA Waived for Fingerstick Whole Blood / CLIA Moderate Complexity for Venous Whole Blood, Serum, Plasma | CLIA Waived |
| CLIA Classified |
CLIA Non-Waived | CLIA Non-Waived | CLIA Non-Waived | CLIA Waived Sample Dependent | CLIA Waived |
| Contents 1 |
RPR Test Card (10-Well), RPR Carbon Antigen, Reactive Control, Weak Reactive Control, Nonreactive Control, 3 mL Dropping Bottle, 20 Gauge Dispensing Needle, Disposable Stirrer Pipets | (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 | (48) Process Buffer Tubes, (48) Reaction Tubes | (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 |
| Country of Origin |
Unknown | Unknown | United States | United States | United States |
| For Use With |
| | For Solana Instrument | | |
| Is_ECAT |
| | N | | N |
| Is_GSA |
| | Y | | Y |
| Is_VA |
| | N | | N |
| Number of Tests |
25 Tests | 24 Tests | 48 Tests | 25 Tests | 25 Tests |
| Product Dating |
| 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 |
| Reading Type |
Visual Read | Visual Read | Machine Read | Visual Read | Visual Read |
| Sample Type |
Serum / Plasma Sample | Vaginal Secretion Sample | Cutaneous and Mucocutaneous Lesion Sample | Whole Blood / Serum / Plasma Sample | Endocervical Sample |
| Specialty |
Microbiology | Microbiology | Molecular | Immunoassay | Microbiology |
| Storage Requirements |
Requires Refrigeration | Requires Refrigeration | Requires Refrigeration | | Requires Refrigeration |
| Test Format |
Test Card Format | Test Card Format | Tube Format | Test Card Format | Tube Format |
| Test Kit Type |
Rapid | Standard | Rapid | Rapid | Rapid |
| Test Method |
Nontreponemal | | | Lateral Flow Method | |
| Test Name |
Syphilis Screen | Candida Species / Gardnerella Vaginalis / Trichomonas Vaginalis | Herpes Simplex Virus / Varicella-Zoster Virus | HIV-1/2 Ag/Ab Combo | Bacterial Vaginosis (BV) |
| Test Type |
RPR Card Test | Microbial Identification | Molecular Diagnostic | Antibody / Antigen Test | Enzyme Activity Test |
| Time to Results |
8 Minute Results | 45 Minute Results | 50 Minute Results | 20 Minute Results | 10 Minute Results |
| UNSPSC Code |
41116129 | 41116129 | 41116144 | 41116144 | 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 |
| Features and Benefits |
- The ASI RPR Card Test is a screening test for the sexually transmitted disease, SYPHILIS
- The ASI™ RPR (rapid plasma reagin) Card Test for syphilis is a qualitative and semiquantitative nontreponemal flocculation test for the detection of reagin (anti-nontreponemal antibody) antibodies in human serum and plasma as a screening test in syphilis serology
- Kit includes: (3) RPR Test Card (10-well), 0.5 mL RPR Carbon Antigen, 0.5 mL Reactive Control, 0.5 mL Weak Reactive Control, 0.05 mL Nonreactive Control, 3 mL Dropping Bottle, 20 Gauge Dispensing Needle (60 drops/mL), (25) 0.05 mL Disposable Stirrer Pipets
|
- 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
|
- The Solana HSV 1+2/VZV Assay is a multiplex in vitro diagnostic test for the detection and differentiation of Herpes simplex virus type 1 (HSV-1), Herpes simplex virus type 2 (HSV-2), and Varicella-zoster virus (VZV) nucleic acids isolated and purified from cutaneous or mucocutaneous swab specimens
- The assay consists of two (2) major steps: 1) specimen preparation, and 2) amplification and detection of target sequence specific to HSV-1, HSV-2 and/or VZV using isothermal Helicase-Dependent Amplification (HDA) in the presence of a target-specific fluorescence probe
- Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s five USB ports
|
- 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
|
- 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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