The Fiix™ Test now available as a fully compliant IVD Image
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The Fiix™ Test now available as a fully compliant IVD

By Hart Bio | 16th June 2020
The Fiix™ Test now available as a fully compliant IVD Image

Hart Biologicals is pleased to announce the availability of The Fiix™ Test as a fully validated and compliant IVD product. As a provider for many years of products used for PT/INR testing, both near-to-the-patient and in the laboratory, Fiix represents the next generation of laboratory Prothrombin Time (PT) tests offering enhanced performance and superior patient outcomes.

The Fiix-PT (Fiix-NR) is a new modified PT that is only affected by reduced factors II and X thereby improving warfarin management and outcome. The variability in INR often associated with labile Factor VII is completely minimised. The reagent is fully compliant for use on both optical and mechanical coagulometers, semi-automated or automated. Each product lot has an assigned ISI and MNPT value. Application notes for some of the current generation automated coagulometers are available on request.

Paul Bates, Sales Manager at Hart Bio said "We are very pleased to finally get Fiix ready for the market. All the necessary work to validate the product to make it commercially available for use by laboratories as an fully compliant IVD are now complete. We are very hopeful that this product because of how it works will offer patients using warfarin as their method of anticoagulation much more effective protection."

Patients using warfarin require regular monitoring by attending clinics quite often organsied by their local hospital where a small sample of blood is analysed. This PT measurement provides a ratio known as the International Normalised Ratio (INR) which is used to assign the daily dose of warfarin a patient should use until the next clinic. Using this new test to generate the INR value has been shown in trials to provide patients a better outcome from their treatment.

Paul went on to say "We already have the the product being used with patients in the clinic situation and we are very hopeful that the use of this test will catch-on when clinicians get to undertand what it offers"


Main Features of the products are:

  • The Fiix test is only sensitive to reductions in the factors responsible for VKA antithrombotic effect, namely factors II and X

  • Warfarin instability can be Fiix™ed by replacing the PT (INR) with Fiix™-PT (Fiix™-NR) monitoring

  • Fiix™ed warfarin has a stabilized anticoagulation effect

  • Fiix™ed warfarin safely reduces thromboembolism by half compared to standard INR monitoring

  • In atrial fibrillation patient’s warfarin managed by Fiix-NR monitoring is at least as effective as composite direct oral anticoagulants (DOACs)

  • Fiix™ed warfarin is a “NOAC” (new oral anticoagulant)

The Kit provides contains materials to complete 200 tests and is available as follows:

The Fiix™ Test Kit - HB-4952-FG (5 x 1 mL lyophilised Fiix plasma reagent,  5 x 3.5 mL PT reagent and 5 x 3.5 mL Imidazole buffer)

More information about the new product can be found at HERE

Other products recommended for use with Fiix are: 

HB-4452-FG        Poller Calibrants® PT/INR Line Plasma Set

HB-4416-FG        Vericon 1 Control Plasma - Normal          10x1ml

HB-4417-FG        Vericon 2 Control Plasma - Abnormal      10x1ml

HB-4418-FG        Vericon 3 Control Plasma - Abnormal      10x1ml