Technology

Prolight Diagnostics develops Point-Of-Care (POC) systems, small mobile instruments with developed test cards that can carry out testing through a simple blood test. POCT tests are performed outside the traditional hospital laboratory.

Prolight Diagnostics develops Point-Of-Care (POC) systems, small mobile instruments with developed test cards that can carry out testing through a simple blood test. POCT tests are performed outside the traditional hospital laboratory. Sampling and analysis of POCT tests usually do not require specific expertise, unlike the technically demanding equipment of the large hospital laboratories.

As the company’s name suggests, the company currently works with the detection of proteins (Pro) via light in an optical system. The company has further developed the well-established ELISA technology from the large laboratory platforms to a microformat. Furthermore, the flex membrane technology used by our strategic partner TTP has been used. We have combined the small format – micro – with the flexible solution – flex – which led to the POC platform’s name, PLD Micro Flex.

Micro ELISA

PLD Micro Flex is based on the ELISA method, a well-established technology in diagnostic contexts. Prolight Diagnostics (PLD) has further developed this technology into a microformat that is well suited for Point-Of-Care and distributed diagnostic testing. The method is patented, with approved patents in Europe and the USA, and several other applications are being processed.

The ELISA method makes it possible to determine whether the sample contains a specific antibody or antigen. The method examines how the patient’s immune system reacts to foreign organisms (antigens). By detecting different antibodies or antigens, different diseases can be diagnosed.

Antibodies are proteins that are produced by the body’s immune system and that bind to foreign substances that have entered the body, so-called antigens.

An antigen is a foreign substance that has entered the body and that causes the immune system to react and produce specific antibodies against that particular antigen.

PLD Micro Flex technology makes it possible to perform an ELISA test with a small disposable test card, which means a faster and easier alternative to measuring substances in blood compared to performing the analysis with a microtiter plate. The test card (approximately 100 mm x 90 mm) is pre-prepared with the reagents needed to measure the concentration of the substance sought in the blood directly from a standard vacuum tube (primary sampling tube). The small format and the convenient, simple user workflow make the principle well suited for POC (Point-Of-Care) testing.

Flex membrane technology

The PLD Micro Flex test card is based on TTP’s Flex membrane technology, which enables the integration of complex flows on a small disposable test card. To facilitate handling and to avoid exposing the user to unnecessary blood contamination, the test card is equipped with technology where the primary sampling tube is mounted and integrated directly on the test card. During the analysis, the system automatically handles the process of extracting the blood out of the sampling tube and preparing the blood for an ELISA test.

The test card contains several flow channels for mixing the sample with selected reagents in the reaction chamber, where a patented mixing technique accelerates the reaction between the antibodies and the antigens, allowing the test to be performed more quickly. By using different antibodies in the test card, different antigens can be detected. A rinse removes any unbound antigens, which improves the sensitivity and specificity of the test. After which, a final chemical reaction is performed to convert the bound antigens to light. The system detects the light with a highly sensitive detector, which enables a measurement of the antigen concentration and reports this to the user.

Patent

The company has a strong patent portfolio consisting of four registered patents relating to micro ELISA technology, two in the USA, one in the EU, and one in Sweden. During the company’s second stage of development, significant progress was made which led to four more patent applications being filed.

Strengths

Mobile
- can be performed by the hospital bed, at the healthcentre, the emergency department, in primary care, or in the intensive care unit.
Time and cost effective
- the samples do not need to be sent to the laboratory for analysis, which saves time. To quickly detect or rule out a heart attack, for example, means the possibility of providing faster care, and that unnecessary hospital stays can be avoided and large care costs can be saved.
Usually does not require specific expertise
- unlike the large hospital laboratories' often technically demanding equipment.
Quick and reliable
- the ambition with the system is to be able to provide analytical results after approximately 10 minutes. The analysis can contribute to safer patient priorities and improved patient flow.
The technology enables breadth
- the technology that is being developed enables several applications within, for example, cancer, trauma and inflammation.
Integration
- the instrument is being developed to make it possible to be connected for export of test results to, for example, patient records.
Contributes to reduced workload
- in emergency units, the personnel’s ability to be efficient and accurate is of great importance. Rapid diagnosis with POCT means that patients in need of rapid and emergency care can be prioritised at an early stage. It creates a better patient flow as patients are diagnosed and treated more quickly.
Analyses close to the patient
- Prolight Diagnostics' POC system means that caregivers can perform the diagnosis directly at the patient's side.
Frees up hospital places
- rapid diagnoses mean that healthcare can quickly screen out patients who are not in need of emergency care.