1-65-1214(C) INSTI Product Specifications Sheet USA (2).pdf
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- Attached to
- Master Agreement AZ|CTR072354
- Contract number
- CTR072354
- Issued by
- Arizona
About this file
This document is a Product Specification Sheet for the INSTI® HIV-1/HIV-2 Antibody Test, produced by bioLytical Laboratories Inc., a Canadian company with a US office in Ferndale, Washington. The specification sheet provides detailed product information for two related medical testing products: the INSTI® HIV-1/HIV-2 Antibody Test (Product Code 90-1019) and the INSTI® HIV-1/HIV-2 Test Controls (Product Code 90-1031).
The INSTI HIV-1/HIV-2 Antibody Test is a one-minute diagnostic test kit priced at $999.50, containing 50 individual tests and supporting materials. It is CLIA waived for fingerstick whole blood and moderate complexity for plasma and venous whole blood. The test kit can be used with fingerstick whole blood, venous whole blood, and plasma, with a shelf life of 15 months. The accompanying Test Controls are priced at $76.99 and include positive and negative controls for HIV-1 and HIV-2. Additional accessories are available separately, including lancets (50 pack, $23.00) and test capillary pipettes (48 pack, $24.95). The test has high sensitivity and specificity rates across different sample types, with reimbursement available through specific CPT and HCPCS codes.
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Text version
Code Product 10-1042
80-1087
Lancets, 50 pack
Test Capillary Pipettes, 48 pack
Price $23.00
$24.95
Main 1 604 204 6784 Toll-Free 1 866 674 6784 Fax 1 604 244 8399 Technical Support customercare@biolytical.com
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HIV-1/HIV-2 Antibody Test Product Specification Sheet insti.com • biolytical.com 65-1214(C) 03/2020
Sample Type
Type Code
INSTI® HIV-1/HIV-2 Antibody Test (50 individual tests with support materials)
Product Code List Price
CLIA Status
Sample Type
Kit Contents
Test Run Time
Shelf Life1
QC
Requirements
Storage Conditions
Performance2
Additional Accessories (Sold Separately)
Reimbursement of INSTI HIV Test
INSTI® HIV-1/HIV-2 Test Controls
Sensitivity Specificity
90-1019 $999.50
CLIA Waived for fingerstick whole blood. Moderate Complexity for plasma and venous whole blood.
Fingerstick whole blood, venous whole blood, plasma
Materials:
50 individual tests per box
1 Single Test with Support Materials
• 1 Membrane Unit
• 1 Bottle 1, Sample Diluent (1.5ml)
• 1 Bottle 2, Colour Developer (1.5ml)
• 1 Bottle 3, Clarifying Solution (1.5ml)
• 1 Single-Use Safety Lancet
• 1 Capillary Test Pipette
• 1 Alcohol Swab
• 1 Package Insert 1 Subject Information Brochure 1 Customer Letter
1 minute
15 months
• For new INSTI operator verification prior to performing testing on patient specimens
• When switching to a new lot number of INSTI test kits
• Whenever a new shipment of kits is received
• When temperature during storage of the kit falls outside of 2°-30°C (35.6°-86°F)
• When the temperature of the test area falls outside of 15°-30°C (59°-86°F)
• At regular intervals as determined by the user facility
2°-30°C (35.6°-86°F) until expiration date
90-1031 $76.99
N/A
Human, plasma-based reagents or serum substitute
Materials:
1 HIV-1 Positive Control (1.0ml) 1 HIV-2 Positive Control (1.0ml) 1 HIV Negative Control (1.0ml) 1 Package Insert 75 Disposable Bulb Control Pipettes
Venous Whole Blood
Plasma
Fingerstick Blood
CLIA Fingerstick Blood 2
CPT & HCPCS Codes
Modifiers
86703 (CPT Code) G0433 (HCPCS Code)
QW or 92
1From date of manufacture 2Based on US Clinical Trials of the INSTI HIV-1/HIV-2 Antibody Test.
Head Office bioLytical Laboratories Inc 406-13251 Delf Place Richmond, BC, Canada V6V 2A2
US Office 1465 Slater Road PO Box 5007 Ferndale, WA, USA 98248
1 minute
12 months
N/A
Store frozen at -20°C (-4°F) or refrigerate at 2°C (36°F) to 8°C (46°F) until expiration date
File details come from the government source that posted it. Updated .