Bio-Rad - Preparing for a Stress-free QC Audit

Quantimetrix Corporation: leading the way in quality controls

Quantimetrix Corp. was set up almost 50 years ago to create clinical diagnostic test kits. CLI caught up with Monty Ban, Chairman, President and CEO, to discover more about the company and how it has developed since it started out.

When was Quantimetrix founded and what was the aim at that time?

Quantimetrix was founded in 1974 by Dr Robert W. Ban PhD with the idea of designing and manufacturing clinical diagnostic test kits that were accurate, reliable and easy to use.

Over many years, and with the ratification of the Clinical Laboratory Improvement Act of 1988, the need for laboratory quality controls grew. Quantimetrix began to focus on designing and manufacturing human-urine-based, liquid-stable controls for urinalysis, and other chemistry assays, focusing on ease of use. It was a challenge to maintain stability in the liquid state because urine is inherently unstable over time.

Laboratory controls are important because they allow the Medical Technologist to easily test an assay by providing a sample that mimics a patient sample, but with known values, to ensure the assay
is producing accurate results.

Most controls were provided in a lyophilized state in the 1980s, were time consuming to reconstitute, and produced a lot of waste. Liquid controls, with long-term stability, simplified the process and reduced waste due to long refrigerated stability. Dipper and dropper style dispensing was also novel, and further simplified use.

Demand for these unique products grew, particularly in the early 1990s, when laboratory inspections became more common.

lab testing controls

What are the important attributes/specifications that good quality controls need to meet?

We strive to maintain the highest standards in our products and services and are always looking for ways to improve.

Early on, Quantimetrix made its name in the field of urine analysis quality controls. How have these products changed since?

The urinalysis field has changed greatly over time to include automated instrumentation, increased emphasis on microscopic constituents and point-of-care testing. Each of these needs have challenged us to evolve our urinalysis product line, which has become the most complete line of urinalysis quality control products in the industry. For example, we now offer products that contain RBCs, WBCs, and other microscopic elements. We also have the only single-use liquid urinalysis control with extraordinarily long stability designed for use in every testing environment, which adds a third method of packaging and dispensing.

We continue to develop new urinalysis quality control products with increased room temperature and refrigerated stability.

What is the process that you go through to develop a new quality control?

The process always starts with the voice of the customer. We develop and manufacture controls for our own branded products as well as our commercial partners. We essentially become an extension of
our partners’ in-house teams, streamlining research efforts, and ensuring optimal outcomes.

We produce our controls in liquid rather than in dry form, and the advantage of that is uniformity. Each bottle contains the same concentration of analytes because they were formulated from a large pool and do not have to be individually reconstituted using varying amounts of water delivered from a pipette. We supplement the controls with certain stabilizers, which causes the control products to become more stable, creating stability for years, instead of months.
As a result, the controls are more reliable, convenient and cost effective for use in the clinical laboratory.

Rigorous testing and adherence to regulatory requirements is paramount. The need for controls will always be necessary for the accurate testing operation of a clinical laboratory. Not only are they mandatory for accurate monitoring of clinical laboratory testing but they are required by the FDA and other laboratory professionals. Clinical controls assure the accuracy and reliability of testing procedures and provide added assurance to the diagnosing physician and ultimately the patient that the diagnosis is reliable.

How did the recent COVID-19 pandemic affect Quantimetrix and were any changes made to the way the company operates or its lines of work as a result?

We learned a lot about ourselves and each other during this time. We learned how to be more resilient, more resourceful and more compassionate. We have also learned the importance of community and the power of human connection.

What do you envisage for the future of Quantimetrix?

We will continue to listen to the needs of our customers and produce solutions for their quality control needs.

New assays are continually evolving, so it’s our job to manufacture products that keep up with our customers’ needs, while continuing to provide easily obtainable, technical support and friendly customer service.

Monty CEO QA

The interviewee

Monty Ban, Chairman, President and CEO
Quantimetrix Corporation, Redondo Beach, CA, USA

For further information visit

Quantimetrix Corporation: