G&H | ITL Case Study: In Vitro Diagnostics

Radioimmunoassay

In the 1980s, G&H | ITL developed a very successful range of single and multi-well Gamma counters for radioimmunoassays. One of these counters was developed and manufactured on an OEM basis for Diagnostic Products Corporation (DPC), now a subsidiary of Siemens Healthineers, following an acquisition in 2007.

Enzyme-Linked Immunosorbent Assay (ELISA)

As ELISA slowly superseded radioimmunoassay in the 1990s, G&H | ITL became involved with developing bespoke instruments that combined multiple reagent storage at 4°C with enzyme reactions running at 37°C. These instruments contained elaborate software able to schedule runs of panel tests, incorporate random access for additional tests and accommodate a stat test for that one sample that the consultant needed right away.

The engineering task of developing this type of instrument was complex. It included throughput expectations for a range of tests and patient samples, patient sample tracking, Laboratory Information Management System (LIMS) communication, and database management requirements. Physical parameters like fluid volume dispensing and aspiration accuracy and precision, temperature tolerances, sample and reagent carry-over requirements alongside the accuracy and precision of movement mechanisms all had to be determined.

Working for companies such as Kodak Clinical Diagnostics and Organon Teknika, we have developed high performance colorimetric, fluorometric, luminometric, and electrochemical readers – among others.

Clinical Microbiology

The patient sample was introduced into the disposable by a clinician and was loaded manually into the instrument. Everything from the introduction of reagents at various stages of the test to incubation was then automated until the final result was fluorimetrically read and presented to the clinician. All of this took place in a sealed cartridge that could be safely disposed of after the test.

Plasmid DNA Purification

Developed by G&H | ITL in 2002, the T-1000 was Tepnel’s first automated DNA purification system. The system is used within the Pharmaceutical and Biotechnology industries to prepare high-quality DNA to be used with DNA sequencing systems.

Polymerase Chain Reaction (PCR)

As PCR has got more sophisticated and incorporated real-time reading, we re-developed an existing PCR machine to read real-time PCR on 96-well microplates. To keep costs low, this involved developing a sophisticated heated lid for the microplates, which could be read through using multi-wavelength fluorimetry coupled to a novel low fluorescence fiber-optic system. We have also designed several IVD devices that used PCR for DNA amplification for later diagnostics. One example is our development project for elements of the QuantuMDx Q-POC. They have the goal of eventually developing a handheld DNA analyzer for 15-20 minute disease diagnostics at the patient’s side.

Molecular Diagnostics and Next-Generation Sequencing

In recent years DNA Sequencing and molecular diagnostics have become easier and faster and are now tipped to be the next big thing in diagnostics. We are involved with clients at the forefront of these technologies, for example, Genomic Vision’s automated scanning and image analysis system for which G&H | ITL is a major product development and manufacturing partner.

This vast engineering experience gathered over many years, along with a strong grounding in biochemistry, separates us from the competition. Couple this with a strong regulatory understanding, in-house laboratories, full ISO 9001, ISO 13485, and FDA-compliant manufacturing. It becomes clear why we are the predominant company in outsourced IVD instrument design and manufacturing.