Home / Clinical Laboratory / Controls / Control Kit / Antibody Test Control Kit AdviseDx SARS-CoV-2 IgG II Level 1 Positive, Level 2 Positive, Negative Level 3 X 4 mL06S6110
Picture of Antibody Test Control Kit AdviseDx SARS-CoV-2 IgG II Level 1 Positive, Level 2 Positive, Negative Level 3 X 4 mL06S6110

Antibody Test Control Kit AdviseDx SARS-CoV-2 IgG II Level 1 Positive, Level 2 Positive, Negative Level 3 X 4 mL06S6110

Antibody-Test-Control-Kit-AdviseDx-SARS-CoV-2-IgG-II-Level-1-Positive,-Level-2-Positive,-Negative-Level-3-X-4-mL06S6110

SKU #

#1187910

MPN #

06S6110

Brand

Abbott

Stock

In Stock

Quantity

100

Features

CONTROL, SARS-COV-2 IGG II ALINITY ADVISE DX (1/KT) D/S

$249.00 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1187910
Manufacturer # 06S6110
Brand AdviseDx
Manufacturer Abbott
Application Control Kit
Container Type Vial
For Use With For the Estimation of Test Precision and the Detection of Systematic Analytical Deviations of the Alinity i System when used for the Qualitative and Semi-Quantitative Detection of IgG Antibodies to SARS-CoV-2 in Human Serum
Levels Level 1 Positive, Level 2 Positive, Negative Level
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Storage Requirements Keep Frozen
Test Name SARS-CoV-2 IgG II
Test Type Antibody Test
UNSPSC Code 41116145
Volume 3 X 4 mL
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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
  • The AdviseDx SARS-CoV-2 IgG II Control Kit is for the estimation of test precision and the detection of systematic analytical deviations of the Alinity i system when used 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)
  • Negative control contains negative human plasma
  • Positive control 1 and positive control 2 contain SARS-CoV-2 IgG positive human plasma