Safe diagnoses at the point of care
Do you manufacture products for point of care testing, and do you wish to optimize your production processes and plants? Are you currently developing a new product for point-of-care testing and have many questions regarding the manufacturing process? Do you need to implement a pilot production facility for FDA approval, or are you seeking a solution for the industrialization of your production? Rychiger would be delighted to put its development competence at your disposal.
We are experts in technologies for the filling of reagents, and the sealing of special containers for the healthcare industry. We know all about the requirements that point of care testing (POCT) kits must meet and assist you in devising a manufacturing solution for your highly complex products – from conception to serial production.
POCT – when time is of the essence
Point of care testing, also known as bedside diagnostics, is the method of choice when time is precious, for instance in intensive care units, operating theaters and emergency rooms, where doctors need to act quickly, but cannot afford doing this without accurate test results.
Point of care testing is also a popular option in primary care facilities, clinics and pharmacies where POCT equipment is already in place. These devices are easy to operate and cost-effective, while returning accurate, lab-standard results within minutes. Thanks to POCT, doctors and other medical professionals are able to diagnose conditions must quicker to start treatment without delay. Point-of-care testing not only save lives but also improves patient flow.
Each point of care test method normally requires a special analytical device into which a POCT cartridge and a sample taken from the patient are placed. The entire analysis is then performed by the smart cartridge in conjunction with the analytical device, doing away manual lab processing.
For accurate results, the equipment must be safe and easy to use right at the bedside. This requires high-precision reagent delivery and optimized packaging. Where the two go hand in hand, users cannot go wrong.
Close to the patient
POCT devices are also found in primary care clinics and pharmacies. They allow for efficient health management, as doctors and patients are able to discuss the issue at hand based on up-to-date test results, so that treatment can start without delay. For intensive care treatment, dialysis and anesthetics where medics must make quick, diagnosis-based decisions, the main benefit of point of care tests is speed. Point of care testing kits are already available for many pathogens, autoimmune diseases and kidney function levels, so that rapid diagnoses make prompt intervention possible.
Other POCT applications
The hemoglobin level (Hb value) and the white blood cell (WBC) count reveal a lot about the general state of health of a patient. Other valuables indicators for a diagnosis are the red blood cell (RBC) count and the platelet count. Using special POCT devices, doctors can now obtain a small blood count right at the bedside and thus decide quickly on the next treatment step, as it is no longer necessary to send a sample to the lab.
INR stands for international normalized ratio and is a laboratory measurement to detect blood clotting problems. Prothrombin time (PT) is a blood test that measures how long it takes blood to clot. This test is routinely performed at the point of care in order to monitor the treatment with anticoagulants.
People who suffer from diabetes need to constantly monitor the glucose level in their blood. POCT devices enable medics to detect potential complications at an early stage so that a suitable treatment strategy can be drawn up.
There are few conditions that require more rapid intervention than infections. With immunological and nucleic acid tests performed at the point of care, the pathogen causing the infection can be quickly identified so that effective treatment can commence without delay.
Solutions for complex applications
POCT methods vary greatly as regards their degree of automation. Certain tests need no automated equipment, and the results are read visually. Other methods require special automated analyzers and POCT cartridges. These cartridges are placed together with the patient sample in the analyzer, and contain highly complex assays that react with the patient sample. The cartridges handle all processes that are normally performed in the lab. This however means that faulty cartridges are likely to return incorrect results, with potentially fatal consequences.
Manufacturers thus face the challenge that their products must be 100% free of defects at the point of use. To achieve this, they must invest in advanced and highly reliable production technology. Rychiger knows all about these challenges and assists you in finding a tailor-made solution for your product.