Comparison |
CLIA Classification |
CLIA Waived for Whole Blood |
Non-CLIA Waived |
CLIA Waived for Fingerstick Whole Blood / CLIA Moderate Complexity for Venous Whole Blood, Serum, Plasma |
CLIA Non-Waived |
CLIA Non-Waived |
CLIA Classified |
CLIA Waived Sample Dependent |
CLIA Non-Waived |
CLIA Waived Sample Dependent |
CLIA Non-Waived |
CLIA Non-Waived |
Contents 1 |
(20) Stat-Pak® Test Devices, (20) Sample Loops, Running Buffer, Quick Reference Instructions, (20) Subject Information Notices, Product Insert |
(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 |
Test Cards, Chase Buffer, Package Insert, Quick Reference Guide, Capillary Tubes, Disposable Workstation |
3 mL Ampule Antigen, 20 Gauge Needle, Antigen Dispensing Bottle, (15) Cards with (10) 18 mm Circle Spots each, (150) Dispenstirs™ Devices, 0.05 mL Delivery |
3 mL Ampules Antigen, Dispensing Needle, Antigen Dispensing Bottle, (50) Cards with (10) 18 mm Circle Spots each, Dispenstirs™ Devices, 0.05 mL Delivery |
Country of Origin |
Unknown |
Puerto Rico |
United States |
Puerto Rico |
Puerto Rico |
HCPCS |
G0435 |
|
|
|
|
Number of Tests |
20 Tests |
24 Tests |
25 Tests |
150 Tests |
500 Tests |
Product Dating |
McKesson接受蒂ng: we will ship >= 60 days |
McKesson接受蒂ng: we will ship >= 60 days |
McKesson接受蒂ng: we will ship >= 90 days |
McKesson接受蒂ng: we will ship >= 60 days |
McKesson接受蒂ng: we will ship >= 60 days |
Sample Type |
Whole Blood / Serum / Plasma Sample |
Vaginal Secretion Sample |
Whole Blood / Serum / Plasma Sample |
Whole Blood / Serum Sample |
Whole Blood / Serum Sample |
Specialty |
Immunoassay |
Microbiology |
Immunoassay |
Microbiology |
Microbiology |
Storage Requirements |
|
Requires Refrigeration |
|
Requires Refrigeration |
Requires Refrigeration |
Test Format |
Cassette Format |
Test Card Format |
Test Card Format |
Test Card Format |
Test Card Format |
Test Kit Type |
Rapid |
Standard |
Rapid |
Rapid |
Rapid |
Test Method |
|
|
Lateral Flow Method |
Nontreponemal |
Nontreponemal |
Test Name |
HIV-1/2 |
Candida Species / Gardnerella Vaginalis / Trichomonas Vaginalis |
HIV Detection |
Syphilis Screen |
Syphilis Screen |
Test Type |
Antibody Test |
Microbial Identification |
Antibody Test |
RPR Card Test |
RPR Card Test |
Time to Results |
15 Minute Results |
45 Minute Results |
20 Minute Results |
60 Minute Results |
60 Minute Results |
UNSPSC Code |
41116144 |
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 |
阅读类型 |
Visual Read |
Visual Read |
Visual Read |
Visual Read |
Visual Read |
Features and Benefits |
- 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)
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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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- Introducing the first FDA approved rapid point-of-care test that detects both HIV-1/2 antibodies and free HIV-1 p24 antigen
- This 4th generation test has the ability to identify HIV sooner than conventional rapid tests which rely solely on the presence of HIV-1/2 antibodies
- Built-in quality controls to let you know the test is working
- Can be performed with variety of sample types
- Test Strips are provided in an aluminum ziplock pouch and can be separated from each other by tearing along the perforated lines
- Each test strip has a cover that is to be removed for sample application and visualization of test results
- Chase Buffer included for use with whole blood samples
- Includes 25 disposable capillary tubes for the collection and transfer of fingerstick samples
- Also includes 25 disposable workstations
- CLIA Complexity: Moderate For Venous Whole Blood, Serum and Plasma Samples
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- Nontreponemal testing procedures for the serological detection of syphilis described in A Manual of Tests for Syphilis
- WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov
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- Nontreponemal testing procedures for the serological detection of syphilis described in A Manual of Tests for Syphilis
- Test kits are available with all the necessary supplies to perform the procedure
- WARNING: Cancer and Reproductive Harm - www.P65Warnings.ca.gov
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