Home / Clinical Laboratory / Clinical Analyzer Calibrators and Reagents / Reagents / Reagent Kit / Reagent Kit Access® Antigen Test SARS-CoV-2 Antigen Assay For use with the Access Family of Immunoassay Systems 2 X 100 TestsC68668
Picture of Reagent Kit Access® Antigen Test SARS-CoV-2 Antigen Assay For use with the Access Family of Immunoassay Systems 2 X 100 TestsC68668

Reagent Kit Access® Antigen Test SARS-CoV-2 Antigen Assay For use with the Access Family of Immunoassay Systems 2 X 100 TestsC68668

Reagent-Kit-Access®-Antigen-Test-SARS-CoV-2-Antigen-Assay-For-use-with-the-Access-Family-of-Immunoassay-Systems-2-X-100-TestsC68668

SKU #

#1182818

MPN #

C68668

Brand

Beckman Coulter

Stock

In Stock

Quantity

100

Features

REAGENT, ACCESS SARS-COV-2 ANTIGEN (2/PKS/KT 100/TST/PK) D/S

$882.06 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1182818
Manufacturer # C68668
Brand Access®
Manufacturer Beckman Coulter
Application Reagent Kit
Container Type Well
For Use With For use with the Access Family of Immunoassay Systems
Number of Tests 2 X 100 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Sample Type Nasopharyngeal Swab Sample
Storage Requirements Requires Refrigeration
Test Name SARS-CoV-2 Antigen Assay
Test Type Antigen Test
Type Chemiluminescent Immunoassay
UNSPSC Code 41116020
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  • This test has not been reviewed by the FDA
  • Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988(CLIA), 42 U.S.C. §263a, that meet the requirements to perform high complexity tests
  • Access SARS-CoV-2 Antigen assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of nucleocapsid antigen from SARS-CoV-2 in nasopharyngeal swabs in Bartels® FlexTrans™ Transport Medium, Copan UTM-RT® , Puritan UniTranz-RT® UTM, Remel MicroTest™ M4RT® or Sigma Virocult® transport media from individuals who are suspected of COVID-19 by their healthcare provider within the first seven days of symptom onset
  • Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status
  • Positive results do not rule out bacterial infection or co-infection with other viruses
  • Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities
  • Negative results should be treated as presumptive and do not rule out SARS-CoV-2 infection and should not be used as the sole basis for treatment or patient management decisions, including infection control decisions
  • Negative results should be considered in the context of a patient’s recent exposures, history and the presence of clinical signs and symptoms consistent with COVID-19, and confirmed with a molecular assay, if necessary, for patient management
  • The Access Family of Immunoassay Systems includes the Access 2, UniCel DxI 600, UniCel DxI 800, UniCel DxC 880i, UniCel DxC 860i, UniCel DxC 680i and UniCel DxC 660i systems
  • 93.3% Positive Percent Agreement (Sensitivity) tested on 47 RT-PCR confirmed positive 7 days post symptom onset
  • 100% Negative Percent agreement (specificity) 7 days post symptom onset
  • Sensitivity concordance is not available at this time
  • Can be run on the same patient population as RT-PCR tests—individuals who are suspected of COVID-19 by their healthcare providers for various reasons, including known exposure or working in high-risk environments
  • No cross-reactivity shown with samples negative to SARS-CoV-2
  • No Biotin interference
  • Instrument throughput of up to: DxI 800 - Up to 200 tests per hour, DxI 600 - Up to 100 tests per hour, Access 2 - Up to 50 tests per hour
  • For use with Nasopharyngeal (NP) Swab & 3ml Transport Media (options include: 1171947 NCS4001 Nasopharyngeal swab, 1167121 B1029-90D Bartels® FlexTrans™ Transport Medium, 996693 220220 Copan UTM-RT® Transport media – 3mL, 1074335 UT-300 Puritan UniTranz-RT® UTM – 3mL, and 785246 220531 Copan UTM-RT Media + NP Swab