IVD Research Reagents

In vitro diagnostics (IVD) is the clinical testing of patient sample material to assess potential health problems. It comprises tests that can be performed quickly and easily at the point of care (POC) as well as more complex analyses that require material to be sent away to a laboratory for testing. To ensure diagnostic accuracy and patient safety, IVD tests are tightly regulated by various global authorities. ICL has been producing key raw materials for the IVD industry for decades, including products for either human or veterinary use. These comprise primary and secondary antibodies, proteins, ELISA kits, and reference standards, all of which are manufactured in the USA for quality you can trust.

What are IVD tests?

IVD tests are used for purposes that include determining whether an individual is infected with an agent such as E. coli or SARS-CoV-2; aiding diagnosis of a condition like rheumatoid arthritis or cardiovascular disease; or monitoring the efficacy of a particular therapeutic such as a drug used for treating cancer. Additionally, IVD tests allow people with chronic disease to manage their own conditions, such as through self-monitoring of blood glucose to support the management of diabetes. Samples analyzed by IVD testing range from serum, urine, and tissue biopsy material, to cerebrospinal fluid, saliva, and tears, and it is common for different IVD test formats to be used for different sample types. While some IVD tests provide POC diagnosis, others are used in combination with the patient’s medical history and physical examination to establish an appropriate course of therapeutic intervention.

What are some common IVD test formats?

Although IVD tests encompass a variety of different formats, lateral flow immunoassay (LFIA), enzyme-linked immunosorbent assay (ELISA), and immunohistochemistry (IHC) are among the most widely used, with each offering distinct benefits.

• Lateral flow immunoassay supports IVD testing at the point of care by providing an almost instant result with no requirement for specialist training. During a LFIA, the sample is simply applied to one end of a nitrocellulose membrane (typically enclosed within a protective plastic cassette) and left to migrate along the test strip; analyte capture gives rise to a colored line on the membrane (often due to an accumulation of gold nanoparticles) for a rapid yes/no result. One of the best known examples of an LFIA for IVD testing is the Clearblue® pregnancy test which detects the hormone human chorionic gonadotropin (hCG) in urine to confirm pregnancy. More recently, LFIAs have been developed for diagnosing SARS-CoV-2 infection.
• ELISA provides the advantages of extremely high sensitivity and the capacity for analyte quantification. It involves capturing the target analyte on the surface of microplate wells, which are then blocked to prevent any non-specific binding prior to analyte detection using enzyme-labeled antibody reagents. Because ELISA can only be run by a trained operative and necessitates access to dedicated equipment such as liquid dispensers, plate washers, and plate readers, its use for IVD testing is restricted to a laboratory setting.
• Immunohistochemistry is used for IVD testing of tissue biopsy material, which must be taken from the patient by a trained medical professional. Following collection, the sample is either snap-frozen in liquid nitrogen or fixed in formalin before being sent away for analysis. IHC involves a complex, multi-step protocol that includes tissue sectioning, antigen retrieval (for formalin-fixed samples), blocking, and immunostaining, meaning it can only be performed by a highly skilled operative with access to all the necessary equipment. A main advantage of IHC over LFIA and ELISA is that it provides insights into the distribution and relative abundance of target analytes within the sample.

High-quality reagents for IVD manufacturing

Irrespective of the chosen IVD test format, diagnostic accuracy hinges on using IVD-grade reagents from a trusted supplier. Primary and secondary antibodies should be rigorously validated for quality and consistency, while proteins and antigens for IVD manufacturing must demonstrate consistent high purity to avoid unwanted background signal that could lead to a false-positive result. We offer an extensive range of IVD-grade materials, including primary antibodies against SARS-CoV-2, human A1c (a biomarker for diabetes), and antibodies for veterinary tests such as diagnosing heartworm or Cryptosporidium parvum (CRP) infection. Our product portfolio also comprises secondary antibodies for detecting IgA, IgG, IgE, and IgM from various species, many of which are cross-adsorbed to minimize unwanted reactivities, as well as a broad range of isotype controls. Complementing our antibody products, our protein offerings include both recombinant and highly purified native proteins.

Why partner with ICL?

With extensive IVD manufacturing experience, ICL is dedicated to producing the highest quality primary and secondary antibodies, proteins, ELISA kits, and reference standards for our partners. Our customers include many of the world’s leading IVD manufacturers, pharmaceutical companies, and research institutions, who know they can count on us, whatever their requirements. All our products are manufactured in the USA under rigorous process control and are backed by rapid customer service to ensure we keep our partners’ projects on track.