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HomePersonal Protection Healgen Covid-19 Rapid Antigen Test (20 Tests)
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INNOVA SARS-CoV-2 Rapid Antigen Lateral Flow Qualitative Test Kit. Box of 25 kits £150.00 £150.00 incl. VAT

Healgen Covid-19 Rapid Antigen Test (20 Tests)

£144.00 £144.00 incl. VAT

This swab test is intended for the rapid detection of COVID-19  – results available within 15 minutes with high accuracy.

  • It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections.
  • The Healgen Covid-19 Antigen Test (Swab) does not differentiate between SARS-CoV and SARS-CoV-2.
  • Each kit contains everything required to carry out the tests, no additional equipment is needed.
  • Approved by Public Health England & validated by the UK government.
  • Results in 15 minutes.
  • Each kit includes clear instructions and is easy to use.
  • Cannot be shipped to a USA address.

The Healgen Covid-19 Antigen Test is one of only three UK Government approved Rapid Antigen Test. It is in high demand from schools, councils and companies.

  • This test is being rolled out by the UK government to mass test the population in Liverpool and other cities, click here for UK Government approval (test 3 on the list).
  • This test is designed for use by clinical professionals (eg Doctor/Practice Nurse/Employer Occupational Health depts etc).
  • An application for exceptional use of a COVID-19 rapid test, to be used by members of the public for home use, was approved on the 23rd December 2020 by the Medicines and Healthcare products Regulatory Agency (MHRA), click here for details.

 Please contact us for orders of 5+ units 

Full instructions are available here.

Clinical Evaluation:

  • Positive Percent Agreement (PPA): 97.3%
  • Negative  Percent Agreement (NPA): 99.6%
  • Overall Percent Agreement (OPA): 98.9%
  • Specimen: Nasopharyngeal (NP) Swab
  • Time to Results: 15 minutes
  • Shelf Life: usually 24 months from the date of manufacture

Benefits:

  • Rapid testing for SARS-CoV-2 antigen within 15 minutes
  • Facilitates patient treatment decisions quickly
  • Simple, time-saving procedure
  • All necessary reagents provided & no equipment needed
  • High sensitivity and specificity

Each kit contains:

  • 20 Test cassettes
  • 20 Sterile swabs
  • 20 Extraction tubes and dropper tip
  • 1 Workstation
  • 2 Buffers
  • 1 Package insert

Performance Characteristics:

  • The Healgen Covid-19 Antigen Test (Swab) has been evaluated with specimens obtained from patients.
  • A commercialised molecular assay was used as the reference method.
  • The results show that the Healgen Covid-19 Antigen Test (Swab) has a high overall relative accuracy.

38 in stock (can be backordered)

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Categories: Infection Control, Lateral Flow Test Kits, Personal Protection
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Description

1. Remove the test cassette from the sealed foil pouch and use it as soon as possible.

2. Lay device on flat surface and add specimen (see specific instructions for each specimen type below):

a. For Serum or Plasma Specimen: With the plastic dropper provided, draw serum/plasma specimen to exceed the specimen line, as shown in the diagram below. Hold the dropper vertically and transfer drawn serum/plasma specimen into the sample well (S). Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

b. For Whole Blood Specimen: Hold the plastic dropper vertically and transfer 1 drop of whole blood (about 10 μL) to the sample well (S) of the test device. Immediately add 2 drops (about 80 μL) of sample buffer to the buffer well (B) ensuring that buffer vial tip does not touch the sample. Avoid air bubbles.

3. Wait for the control line (C) to change from blue to a red color. If, after 2 minutes, the sample has not moved across the test window or if blood is still present in the sample well (S), add 1 additional drop of sample buffer to the buffer well (B).

4. The results should be read in 10 minutes. Do not interpret the result after 15 minutes.

Warning

​This test has been authorized by FDA under an EUA for use by authorized laboratories. ​

This test has not been FDA cleared or approved.

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.

This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

​Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.

​This product is intended for professional use and not for home use.

​Not for the screening of donated blood.

FACT SHEET FOR RECIPIENTS

FACT SHEET FOR HEALTHCARE PROVIDERS

 

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All PPE – 1-2 Days Delivery – DPD

Protective Screens and Clamps

Protection Screens 3-5 Days Delivery – DPD or DX 

Clamps – 3-5 Days Delivery – DPD or DX (Mostly in stock)

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For queries: 

0203 9835615

Email: [email protected]

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