Home / Clinical Laboratory / Test Kits / Rapid Test Kit / Rapid Test Kit Biotime Antibody Test SARS-CoV-2 IgM / IgG Whole Blood / Serum / Plasma Sample 25 Tests5300000978
Picture of Rapid Test Kit Biotime Antibody Test SARS-CoV-2 IgM / IgG Whole Blood / Serum / Plasma Sample 25 Tests5300000978

Rapid Test Kit Biotime Antibody Test SARS-CoV-2 IgM / IgG Whole Blood / Serum / Plasma Sample 25 Tests5300000978

Rapid-Test-Kit-Biotime-Antibody-Test-SARS-CoV-2-IgM--IgG-Whole-Blood--Serum--Plasma-Sample-25-Tests5300000978

SKU #

#1181150

MPN #

5300000978

Brand

Horiba

Stock

In Stock

Quantity

100

Features

TEST KIT, RAPID SARS COVID-19 IGG/IGM BIOTIME (25/KT) D/S

$283.09 USD

Product Specifications Product Usage Additional Information
Print
Attribute Name Attribute Value
McKesson # 1181150
Manufacturer # 5300000978
Brand Biotime
Manufacturer Horiba
Application Rapid Test Kit
Contents (25) Test Cartridges, Bottle of Detection Buffer, (25) Pipettes, Instructions for Use
Number of Tests 25 Tests
Product Dating McKesson Acceptable Dating: we will ship >= 90 days
Reading Type Visual Read
Sample Type Whole Blood / Serum / Plasma Sample
Storage Requirements Requires Refrigeration
Test Format Cartridge Format
Test Method Lateral Flow Immunoassay
Test Name SARS-CoV-2 IgM / IgG
Test Type Antibody Test
Time To Results 20 Minute Results
UNSPSC Code 41116126
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  • Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test assay is only for use under the Food and Drug Administration’s Emergency Use Authorization: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations
  • This test has been authorized by FDA under an EUA for use by laboratories certified under Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet requirements to perform moderate or high complexity tests
  • Biotime SARS-CoV-2 IgG/IgM Rapid Qualitative Test is a lateral flow immunoassay intended for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma (potassium EDTA), and potassium EDTA venous whole blood
  • This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the authorization is terminated or revoked sooner
  • At this time, it is unknown how long antibodies persist following infection and if the presence of antibodies confers protective immunity
  • Should not be used to diagnose acute SARS-CoV-2 infection
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens
  • Laboratories within the United States and its territories are required to report all results to the appropriate public health authorities
  • Negative results do not preclude acute SARS-CoV-2 infection; if acute infection is suspected, direct testing for SARS-CoV-2 is necessary
  • 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
  • External controls sold separately (1 positive and 1 negative control)
  • Easy to use: Just 3 Steps
  • Results in 20 Minutes
  • IgM: 100% sensitivity; IgG: 96.7% sensitivity