Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgG II For use with the Alinity i System 1,000 Tests 27 mL Microparticles, 26.5 mL Conjugate, 36.9 mL Diluent06S6130
Picture of Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgG II For use with the Alinity i System 1,000 Tests 27 mL Microparticles, 26.5 mL Conjugate, 36.9 mL Diluent06S6130

Reagent Kit AdviseDx Antibody Test SARS-CoV-2 IgG II For use with the Alinity i System 1,000 Tests 27 mL Microparticles, 26.5 mL Conjugate, 36.9 mL Diluent06S6130

Reagent-Kit-AdviseDx-Antibody-Test-SARS-CoV-2-IgG-II-For-use-with-the-Alinity-i-System-1,000-Tests-27-mL-Microparticles,-26-5-mL-Conjugate,-36-9-mL-Diluent06S6130

SKU #

#1187912

MPN #

06S6130

Brand

Abbott

Stock

In Stock

Quantity

100

Features

REAGENT, SARS-COV-2 IGG II ALINITY ADVISE (1000TEST/KT) D/S

$7,500.00 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1187912
Manufacturer # 06S6130
Brand AdviseDx
Manufacturer Abbott
Application Reagent Kit
Container Type Cartridge
For Use With For use with the Alinity i System
Number of Tests 1,000 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Sample Type Human Serum / Plasma Sample
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 IgG II
Test Type Antibody Test
Type Chemiluminescent Microparticle Immunoassay (CMIA)
UNSPSC Code 41116020
Volume 27 mL Microparticles, 26.5 mL Conjugate, 36.9 mL Diluent
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  • The AdviseDx SARS-CoV-2 IgG II assay is for use under an Emergency Use Authorization Only: https://www.fda.gov/medical-devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-devices/in-vitro-diagnostics-euas#individual-serological
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) of 1988, 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • The AdviseDx SARS-CoV-2 IgG II assay is a chemiluminescent microparticle immunoassay (CMIA) intended for the qualitative and semi-quantitative detection of IgG antibodies to SARS CoV-2 in human serum (including collected using a serum separator tube) and plasma (acid citrate dextrose, sodium citrate, dipotassium EDTA, tripotassium EDTA, lithium heparin, lithium heparin in a separator tube, and sodium heparin) on the Alinity i system
  • At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity
  • The AdviseDx SARS-CoV-2 IgG II assay should not be used to diagnose or exclude acute SARS-CoV-2 infection
  • A positive result may not indicate previous SARS-CoV-2 infection; consider other information, including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response
  • A negative result for an individual subject indicates the absence of detectable anti-SARS CoV-2 antibodies; Negative results do not preclude SARS-CoV-2 infection and should not be used as the sole basis for patient management decisions
  • A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies in the specimen is below the detection limits of the assay, or if the antibodies are not present during the stage of disease in which a sample is collected