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KOVIFAST™ Covid-19 & Flu A/B 3 in 1 Rapid Test (CE Certified)

The KOVIFAST™ Covid-19 & Influenza Antigen Combo Rapid Test brought to you by Alpha and Omega MedTech (Pty) Ltd. South Africa: is intended for the qualitative detection of SARS-CoV-2, influenza A virus, and influenza B virus antigen in human deep throat sputum specimens, throat swabs, and nasal swabs.

    • Accurate: Sensitivity 92.1%, Specificity 100%, with overall consistency results exceeding 95% when compared to RT-PCR testing

    • Affordable: as low as 10% of the cost of RT-PCR testing

    • Easy: even possible for home use

    • Fast: results available onsite in 15 minutes

    • Portable: the entire test is supplied in a hand-sized pack with no additional equipment required

Certification

CE

Incoterms

FOB

Minimum Order

1000 Units

$5.00 $4.50

Features and Benefits:

The KOVIFAST™ Covid-19 & Influenza Antigen Combo Rapid Test  is a highly scalable testing solution:

  • Accurate: Covid-19: 96.6% overall consistency compared with RT-PCR (92.1% sensitivity; 100% specificity). Flu A:  93.4% overall consistency compared with RT-PCR (100% sensitivity; 90.9% specificity). Flu B: 98.5% overall consistency compared with RT-PCR (95.8% sensitivity; 99.3% specificity).
  • Comprehensive: simultaneous and differentiated testing for SARS-CoV-2 virus and influenza A and B
  • Easy: even possible for home test use
  • Fast: results are available onsite in 10 minutes
  • Portable: the entire test is supplied in a hand-sized pack with no additional equipment required

Product Specifications:

  • Sample collection method: deep throat sputum as the preferred method; or throat and tonsil (oropharyngeal) swab as an alternative method if sputum cannot be produced
  • Test kit contents: disposable swab (one); dropper tube (one); diluent vial (one); sputum dish (one); test cassette (one)
  • Storage conditions: 2 to 30°C away from direct sunlight; use within 12 months from date of manufacture
  • Packing: One Test (single boxed test kit); Twenty Test Shipping Box (twenty single boxed test kits in one shipping box); Twenty Test (twenty individual single test kits in one bulk box)

CE conformity, Implementation of Directive 98/79/EC on in vitro diagnostic medical devices, Annex III

Applicable Standards:

ISO 13485:2016

ISO 14971:2019

EN ISO 18113-1:2011

EN ISO 18113-2:2011

EN 13641:2002

ISO 15223-1:2016

EN 13612:2002

ISO 23640:2015

EN 62366-1:2015

Additional information

Certification

CE

Incoterms

FOB

Minimum Order

1000 Units

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Vendor Information

  • Store Name: Alpha and Omega Medtech
  • Vendor: Brett Lyndall Singh
  • Address: Pietermaritzburg, Kwa Zulu-Natal South Africa
    Pietermaritzburg
    3202
    South Africa
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