What are IVD tests?

In Vitro Diagnostics (IVD) tests are used to detect diseases, conditions, and infections. In vitro is Latin for in glass, meaning tests are done on samples that have been taken from the human body. These tests collect biological samples including blood, urine, tissue, saliva, etc.

Healthcare providers and laboratory facilities employ these tests not only for diagnosis and treatment, but also a proactive measure in preventative medicine. With over 40,000 different IVD products available, these tests provide valuable information to doctors and patients on a wide range of conditions.

Point-of-Collection: Where are samples collected and tested?

At-Home Testing:

At-home test kits are typically available to purchase at your local pharmacy, or ordered online. These may include pregnancy tests, flu tests, HIV tests, COVID-19 tests, and more. At-home test kits typically provide immediate results.

Following the provided instructions, samples are gathered at home where they are then sent to a laboratory for analysis. These may include fertility tests, genetic tests, and more.

Hospitals & Doctor Offices Testing:

Samples collected in a healthcare setting may provide immediate results, however, testing is typically done within a laboratory. 

While certain hospitals and doctor offices may have point-of-care testing devices for immediate sample analytics, typically laboratory medical couriers are responsible for collecting samples. These samples are then promptly delivered to a local laboratory on the same day or sent via courier for overnight delivery. 

For critical samples obtained, direct courier services to specialty laboratories are necessary, and sample shipping kits are usually supplied by the laboratory.

Laboratory Testing:

While some IVD tests are conducted at home or in healthcare settings, some are developed and tested in a laboratory.

While at-home and hospital IVD test kits are mainly one-size-fits-all (available for patients to use on their own), laboratory developed tests (LDTs) are only authorized to use by the laboratory who developed them. Patients are generally advised to visit a laboratory for sample collection and the laboratory conducts the LDT based on its private protocol.  

The tests developed and performed by laboratories are more complex as they are often developed in-house by request, and are targeted specifically to a patient’s individual needs.

Samples for LDTs may be collected at-home, in a healthcare facility, or at the laboratory itself. Most of the time, the laboratory will ship a sample collection kit to the patient or their physician, where the collected samples will be shipped back to the laboratory.

Common samples tested by IVD kits: How are they maintained during shipping?

Specifically when transporting samples to laboratories, temperature-sensitive specimens need to be maintained within a certain temperature range to avoid excursions. If not, specimens may lose their integrity and be rejected. If this occurs, specimen collection will have to be repeated which would lead to delay in patient care and increase costs for all stakeholders.

• Blood Samples

Blood samples may be transported to examine cells, chemicals, proteins, or other substances in the blood. Whole blood samples used for pharmacogenomic testing are recommended to remain within a controlled room temperature (CRT) range (15˚C to 25˚C) or frozen below -18˚C during transportation. Samples for personalized testing must remain within a CRT range (15˚C to 25˚C) only, and should not be frozen.

• Saliva Samples

Most saliva samples are recommended to be stored and transported at controlled room temperature (15°C to 25°C), avoiding lengthy refrigeration.

• DNA Samples

DNA specimens are recommended to be shipped overnight at room temperature (15°C to 25°C). If shipping is expected to take longer, it is required for the specimen to be refrigerated ( 2°C to 8°C). Frozen DNA specimens should be shipped overnight.

• RNA Samples

Pre-collection RNA samples and Hereditary Cancer Blood samples are recommended to be kept in a controlled room temperature range (18°C to 25ºC). 

For post-collection, they are recommended to be kept in a controlled room temperature range (18°C to 25ºC) or refrigerated ( 2°C to 8°C) until pickup.

• Post-mortem Samples

Post-mortem specimens should be shipped overnight at room temperature (15°C to 25°C). If shipping is expected to take longer, they are recommended to be kept at refrigerated temperatures ( 2°C to  8°C). Frozen post-mortem specimens should be shipped overnight.

Importance of Temperature Control When Transporting IVD and LDT Samples

Given how sensitive many biological samples are to temperature excursions, ensuring consistent temperatures is an essential part in the transportation process. Preserving the quality and integrity of samples is crucial for patient care, emphasizing the important role of temperature control during transportation. Maintaining optimal sample conditions not only reduces the risk of rejected specimens but also translates to significant time and cost savings associated with avoiding the need for recollection.

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