COVID-19 Antibody Rapid Test – Barrel Format

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BioSURE® COVID-19 Antibody Rapid Test is housed in a novel barrel device and is a single use in-Vitro diagnostic test for the qualitative detection of COVID-19 (SARS-CoV-2) IgG antibodies in human finger prick whole capillary blood. This test is certified for professional use only.
• Minimum Order Quantity (MOQ): 10 tests
• Seller Name: BioSure
• Seller Location: United Kingdom
• Warranty Term: Not applicable
• Regulatory Approval: CE, MHRA

Description

BioSURE® COVID-19 Antibody Rapid Test is housed in a novel barrel device and is a single use in-Vitro diagnostic test for the qualitative detection of COVID-19 (SARS-CoV-2) IgG antibodies in human finger prick whole capillary blood. This test is certified for professional use only.

All the components needed are included in each pouch and this test needs no manual mixing or measuring. No additional equipment is needed, it is proven to be simple to perform and gives an easy to read, binary result of one line (negative) or two lines (positive) in 10 minutes.

Key Features

Safety
This test is CE marked for Professional Use Only and is registered with the MHRA. It was developed and is manufactured in it’s entirety in the UK, making it the only UK manufactured test currently available.

Specifications

Sensitivity and Specificity

  • Sensitivity: 98.3% (CI: 90.9-100%)
  • Specificity: 98.8% (CI: 96.6-99.8%)

Performance

  • Sample Type: Finger prick whole capillary blood
  • Sample Volume: 8-9μl
  • Test Time: 10 minutes

Operating and Storage Conditions

  • Operation Temperature: 8° – 30°C
  • Storage Temperature: 2° – 30°C

Standard Accessories

Not applicable

Optional Accessories & Add-ons

Not applicable

Product Documents, Manuals & Brochures

Product Insert

Regulatory Certificates

Declaration of Conformity

Videos

Not available at this time

 

Studies & Trials

Not available at this time

 

Package Contents

  • 10x BioSURE COVID-19 Antibody Test Pouches; each pouch contains:
    • 1x BioSURE COVID-19 barrel test device
    • 1x Single use safety lancet
    • 1x Plaster
    • 1x Product insert
    • 1x Test stand

Warranty

Not applicable

Not available at this time

 

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