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EditorBiotin: Mechanisms of interference in immunoassays and mitigation strategies

By Victor Leung, Dana Nyholt-Bailey, IQMH Endocrinology and Immunology Scientific Committee and Staff


Recent years have seen a significant increase in the number of cases of biotin interference with streptavidin-biotin (SB)-based immunoassays reported in the literature. Biotin interference with laboratory tests, specifically SB-based immunoassays, is potentially dangerous, as it may cause spurious test results leading to misdiagnosis and patient mismanagement.

The U.S. Food and Drug Administration (FDA) recently reported increased adverse events related to biotin interference of SB-dependent immunoassays including a falsely low troponin and subsequent death1, whereas Health Canada has published at least nine Recalls & Safety Alerts since 2017 related to biotin interference of lab tests in commonly used clinical analyzers.2 Most commonly are those associated with inaccurate thyroid hormone or PTH quantitation; most significantly are those associated with deaths including false-negative troponin. Less commonly reported are interferences impacting pregnancy testing or infectious disease serology. These public reports clearly demonstrate an urgent need to address the issues pertaining to biotin interference.

What is biotin?

1 day ago

EditorServer Shutdown - QView™ and will not be available and will not be available on Saturday, January 25th starting at 9:00 p.m. (ET) until 9:00 a.m. (ET) due to planned maintenance. You are encouraged to make appropriate work-related arrangements to accommodate the server shutdown.
We apologize for any inconvenience this may cause. 

2 weeks ago

EditorA New Outlook on Internal Auditing in London, Ontario

Thursday, April 30 to Friday, May 1, 2020

2 weeks ago

EditorPresident's End of Year Message

There are times it feels difficult to believe that the holiday season is almost upon us once again. This year seems to have gone by especially quickly! I guess the old adage about time appearing to pass by faster and faster the older you get is true—at least for me!  In any case, here we are, and I’d like to take this opportunity to wish you peace, hope and joy during the holiday season, and throughout 2020.

1 month ago

EditorVersion 8 of the IQMH Medical Laboratory Accreditation Requirements is now available!

We are pleased to announce that Version 8 (December 2019) of the IQMH Medical Laboratory Accreditation Requirements is now available. Laboratories currently enrolled for IQMH Accreditation have access to all files related to this version via their password-protected QView™ account. The QView™ folder with these files can be found under “General - Accreditation, Laboratory Program, Accreditation Requirements”. It contains the requirements, a change report comparing Version 7.1 to Version 8, and an updated list of references to support the requirements. Documents are available in English and in French.

1 month ago

EditorCongratulations to our newest ISO 15189 Plus™-accredited facility

We are pleased to announce that
William Osler Health System has achieved ISO 15189 Plus™ Accreditation for the services they provide on the floor they operate at the Reactivation Care Centre (RCC), Church St. Site.

1 month ago

EditorView the new Anatomic Pathology e-Learn LAB module!

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1 month ago

EditorHoliday office closure notice

<img alt="" src="/Portals/0/Docs/Resources/News/Elevate/2019-12/Closed-for-the-Holidays.png" />

1 month ago

EditorOrder Deadline for Proficiency Testing surveys is fast approaching. Act now!

The IQMH Centre for Proficiency Testing is pleased to announce the availability of its Proficiency Testing Programs in the 2020 Catalogue.

1 month ago

EditorBulletin: Important Changes to IQMH Chemistry and Endocrinology Proficiency Testing Surveys in 2020

Attention: Chemistry and Endocrinology Proficiency Testing (PT) Participants

1 month ago

EditorIQMH delivers extraordinary IQMH Fall Forum on Innovations in Cancer Diagnostics

On November 7–8, 2019, IQMH hosted a forum centred  on innovations in cancer diagnostics. It is our belief that live events such as this are a valuable contribution to the sharing of knowledge among laboratory professionals. 

A gathering of diagnostic medicine leaders and professionals who want to elevate themselves, learn, share, network and get excited about diagnostic medicine, an IQMH Forum is never a typical conference. Why? Each event is underpinned with a specific theme and intention to ensure the programme will drive meaningful change and infuse a new outlook on quality. Our aim is to energetically inspire the diagnostic medicine community to overcome barriers and embrace the future. 

1 month ago

EditorPT Take-Away: Enrolment in IQMH Transfusion Medicine Proficiency Testing program includes a value-added educational component

The IQMH Centre for Proficiency Testing has published a document for participants in the Transfusion Medicine proficiency testing program. Review – Crossmatching, developed  by members of the IQMH Transfusion Medicine Scientific Committee, summarizes the current scientific literature regarding crossmatching. The document will be reviewed and updated periodically for continued relevance.

2 months ago

EditorCall for IQMH Committee Applications 2020-2022

IQMH is seeking a volunteer to sit on its Proficiency Testing Scientific Committee, effective January 1, 2020.   Membership on committees consists of a three-year term of office, renewable once. Committees meet an average of four times a year for half-day or full-day meetings.


    2 months ago

    Editor commented on Uniting to advance quality healthcare: Accreditation Canada and IQMH join forces

    Thanks for your question. There is no anticipated change to existing clients at this time.

    2 months ago

    EditorCongratulations to our newest ISO 15189 <em>Plus</em> ™-accredited facility

    We are pleased to announce that Victoria Laboratories Limited located in San Fernando, Trinidad has achieved ISO 15189 Plus™ accreditation (selected disciplines). In choosing this option, the facility sends a clear signal of commitment to quality for staff, patients, and other healthcare providers.

    2 months ago

    EditorCourse Offers in November at the IQMH Office

    November 14–15, 2019

    2 months ago

    EditorReview of the Top Ten Most Frequently Cited Non-Conformances to Version 8 of the IQMH Accreditation Requirements for Medical Laboratories

    The IQMH Centre for Accreditation is in the final stages of approval of Version 8 of the IQMH Accreditation Requirements for Medical Laboratories.  Version 7 was used for assessment of our medical laboratory participants starting in early 2017, with Version 7.1 coming into effect in mid 2017. This article is a review of the most frequently cited non-conformances to these requirements. It is based on data from 287 assessments and included laboratories in Ontario, New Brunswick, Newfoundland and some international clients.

    2 months ago

    EditorProficiency Testing packages: Changes to expect in 2020

    In response to participant feedback, IQMH will be changing the packaging used to ship proficiency testing survey material. Starting in October 2019 and continuing into 2020, IQMH will be gradually rolling out two changes:

    New Packaging    New Label

    2 months ago


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