Technological Advancement in the Era of Rapid Diagnostics

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Point of care testing is also known as decentralized testing, ancillary testing and bedside testing which is used to provide results to the patients immediately near their site and can be performed by any clinical staff without any training. POCT manufacturer are trying to design a product that should provide comfort to the users in cost- effective manner. Point of care testing is divided into two categories-

1. Waived Testing
2. Non- Waived Testing

Waived Testing:  Waived testing are those non- critical tests which are approved by the FDA for home use and are simple and gives accurate results.  Even if performed incorrectly, they cannot cause any harm to the patients. There are around 1400 tests that have been waived. Urine pregnancy tests, blood glucose by glucose monitoring, ovulation tests, blood count etc. are some of the tests that are granted under the waived testing.

• In March 2018, Sekisui Diagnostics announced the launch of their Silaris Influenza A&B tests which is a polymerase chain reaction (PCR) testing platform specifically for point-of-care (POC) infectious disease diagnosis. It will give accurate and quick results specifically for point-of-care (POC) infectious disease diagnosis. They will give results accurately and quickly.
• In July 2017, Immunalysis Corporation got approval for SEFRIA Fentanyl Urine Enzyme Immunoassay from the U.S. Food and Drug Administration (FDA) which will be used for the detection of fentanyl in urine. Before the approval it was only available for forensic testing; now it is available for CLIA certified reference laboratories, hospitals, physician, offices and other healthcare centers.
• In July 2016, Cepheid announced that they received approval from U.S. Food and Drug Administration (FDA) and Clinical Laboratory Improvement Amendments (CLIA) for their Xpert Xpress Flu/ RSV test which will use the patient specimen to detect the influenza A and B viruses, and RSV RNA in just 20 minutes.
• In April 2015, Diagnostics Direct LLC announced the launch of their first CLIA- waived rapid treponemal syphilis test- Syphilis Health Check which got approval by The U.S. Food and Drug Administration (FDA). It can be performed by using sample of blood from finger stick and will give result in 12 minutes.

Non Waived Testing:  Non waived testing is categorized as moderately complex testing and highly complex testing.  Laboratories where these tests are performed should have CLIA certificate, and should meet the CLIA quality standards.

• Moderately Complex Testing: To perform this test very less technical and scientific training is required and operational steps are usually easy to execute. In this usually, independent interpretation and judgement is required.  They are usually simple and can be adapted for alternative site testing because they are portable.
• Highly Complex Testing: These tests require special training and scientific knowledge, usually comprehensive interpretation and judgement is required so that it can be performed accurately.

Types of Point of Care Testing Tests

To get results instantly and easily these days point of care testing devices are used so that treatment can be started as soon as possible after the detention of the disease.  They give instant feedback for various medical tests. They are designed in such a way so that they can provide patient safety and convenience. POC devices are of different kind, some are handheld and some are benchtop models which require large space.  Some of the point of care testing test includes-

1. Blood Glucose Monitoring- It is a testing which is done so that one can analyze the concentration of glucose in the blood and plays an important in the diabetic management. It helps the patient to manage their diet, exercise and other routine activities as per their results. They usually uses blood glucose meter to measure the blood glucose level. It requires a small blood droplet on a test strip which is connected to a digital meter and in few seconds it displays the result in digital display.

• • In October 2018, Lifescan, Inc announced the launch of their OneTouch Verio Reflect blood glucose meter at European Association for the Study of Diabetes (EASD) 2018 annual meeting. It will help the patient analyze their pattern and inform them about blood glucose trends. It will provide personalized guidance which will help them to detect whenever their sugar level is rising or falling and ColorSure technology will help them understand when their results are nearing highs or lows.
  • In February 2017, SRL Diagnostics launches a unique technique Sugar Trendz which will help the patient to track and monitor their blood sugar level which helps them to manage their exercise and diet. It will help the diabetic patient to monitor their sugar level and make changes in their lifestyle as per that.

2. Urine Dipsticks- Urine dipsticks is tool which is done as a part of urinalysis, and is usually done for the diagnosis of urinary tract infection, kidney disease, diabetes or urinary tract injury. These strips usually 10 different chemical pads which changes color when removed from the urine sample. It usually takes around 60 to 120 seconds to display the results. They are also used for the analysis of protein, glucose, ketones, hemoglobin, acetone, nitrite etc.

• • In May 2018, Quantimetrix announced the launch of their new Dipper- POCT Single- Use Liquid Urinalysis Dipstick Control which has room temperature stability of 3 months and 3 years refrigerated from the date of manufacture. The pouch design minimizes the risk of contamination and also lessens the volume required for testing.
  • In June 2018, Healthy.io launches at home digital testing kit io’s Dip. Io. It will enable the user to collect and analyze the urine samples via smartphone apps, a dip stick, a color-coded slide, and a dash of artificial intelligence. In this, patient have to follow the instruction and wait for the color on the stick and click the picture of the result with the smartphone app, and which will be analyzed by the machine.

3. Urine Pregnancy: Pregnancy is a test which is done to detect whether a women is pregnant or not and urine samples are used for this. A pregnant women placenta produces a pregnancy hormone called human chorionic gonadotropin (hCG) and test is usually used to detect this hormone.  Urine Pregnancy test can be done at home easily, one just have to follow the instructions given.  There are two types of hCG tests-

a. Qualitative hCG Tests- which normally checks whether hCG is present or not.

b. Quantitative hcG Test- which measures the exact amount of hCG present in the blood.

• • In March 2019, PeeBuddy announced the launched of their home pregnancy testing space-PeeBuddy PregRX which will be a unique funnel with strategically- HcG test strips. It is an easy- to use and eco- friendly home testing process in which women simply have to pee and ca check their results without the use of any plastic bottle, tumbler or dropper.
  • In December 2017, Lia Diagnostics has launched their Lia pregnancy kit which is the first- ever flushable kit which is a convenient and private way for the women to find whether they are pregnant or not. It is made of non- biodegradable material which will end up in landfills if not recycled. They are made of special paper that can disperse in water.

4. Lipid Analysis: Lipids are fat like substance that contains hydrocarbons and make the structure and functions of living cells. Lipid panel test is done to check analyze the lipid in blood so that user can analyze the risk of cardiovascular disease. For lipid panel, one has to avoid eating for 10 to 12 hours before the test and have to avoid liquids other than water. By inserting a needle into a vein in arm or from a finger stick, blood sample is obtained.

• • In August 2016, Mayo clinics announced the launch of their new blood test that will be used to measure the blood concentration of plasma ceramides which is linked with the cardiovascular disease processes. This test will help the clinicians to identify the at- risk individuals. It will also help them to analyze whether the treatment is required at emergency level or not.

There are many other tests like RSV, gastric occult blood, hemoglobin A l c, creatinine, prothrombin time, pH determination by pH paper/ strip, influenza etc. so that people can easily detect the disease and can start the treatment. As point of care testing is very successful in detection of many infectious diseases, there is increase in the demand of these products worldwide due to which today new technologies are used in this. The portability and rapid turnaround time is the main benefit of POCT. Due to which many hospitals have started adopting POCT technologies as they are solution for the one of the biggest problem i.e. labor shortage. So, Point of care testing devices is going to expand worldwide with new technological advancement.