Point-of-care testing devices

Point-of-car (POC) diagnostics becomes increasingly popular in nowadays medicine. In Russia, there is no exactly corresponding technical article, however one can’t say that there are no similar devices available on the local market. Let’s have a look on those devices and try to understand how their manufacturing and sales are regulated.

Definition

Abroad

The term concerned consists of two parts: “point-of-care” and “testing devices”:

• 

  Pic. 1: Application of a POC device in a hospital. Source: https://www.clearstate.com/the-future-of-point-of-care-testing-in-asia-pacific/

  Point of care usually means the place (and time) where (and when) the healthcare professionals provide related services to the patient. This may include patient bedside, ward, surgical operation room etc.

• Testing devices are equipment items used to perform tests.

So, in other words, point of care testing devices (POC TD, POC systems, POC tests) are mobile devices used for laboratory diagnostics. Usually, such devices can be used immediately at the patient bedside, and results are provided within few minutes. [1], [2]

The European Parliament in the briefing related to the diagnostic equipment used for IVD provides the following definition of in vitro diagnostic devices:

In vitro diagnostic medical device means test used on biological samples to determine diseases, infection and in general the status of a person’s health, which is conducted outside of the patient’s body. [3]

Generally, POC devices fall within the scope of this definition, however they are rather a subclass of in vitro technologies.

In foreign publications, one can see the following definition of point of care testing (“bedside testing”, “near patient testing”, “extra laboratory testing”):

This is testing performed at the point of care (near patients, at the patient bedside, or as extra laboratory testing). The main purpose of point-of-care systems is a quick delivery of test results as part of treatment process, in order to improve clinical and economical indices of treatment. [4]

or

Clinical laboratory tests performed close to the point of patient care, usually by the clinical staff without specific laboratory testing experience, or often by the patient itself (self-monitoring).[5]

Within the RF

In Russian publications, point-of-care is explained as

• Express diagnostics, based on the analysis of certain markers performed immediately at the patient bedside. [6]
• Express test systems. [7]
• Measurements or diagnostics performed immediately at the point of care. [8], [9]
• Test systems focused on point of care usage immediately at
•  the bedside of the patient. [10]

So, in the RF, point-of-care testing predominantly means usual express test systems, such as COVID-19 express testing, glucometers, blood drug tests etc.

Application

Often, POC device is portable piece of equipment (e.g. glucometer, nerve conduction measurement system etc.) or test kit. The main idea is to provide quick and reliable test possibility for the patient. This will allow clinicians to decide promptly on the further treatment, therefore increasing its efficiency.

Also, multi-complex testing becomes more and more popular, i.e when single sample is used for determination of multiple parameters by the same device. [1], [11]

 

Types of analyses performed by POC tests

Location and circumstances specific For POC test application [11], [12]

Drug abuse screening Strip based urine tests Pregnancy tests Faeces analysis Food pathogens screening Tests for certain infections Cholesterol screening Determination of Hb and glucose level in blood CDC Cardiac markers test1 Platelet function test Streptococci A detection HIV test and screening Malaria diagnostics etc. etc.

Renal Dialysis department Diabetes clinic Labour ward General practice office Nursery home Home care Outpatient and mobile clinics Paramedics and emergency services Emergency vehicles (cars, helicopters) Medicine in sports Disease outbreaks, catastrophes Remote locations, “third world” countries Military use Pharmacies Penitentiary facilities Alternative medicine professionals Mass actions in healthcare (such as massive population-wide screening) Veterinary medicine Fitness facilities Intensive care and resuscitation units (ICU) etc. etc.

Review

There is a bunch of publications dedicated to the analysis of efficiency of POC systems. For example, in one of the university hospitals in Great Britain, in the trauma care and emergency care departments, the randomised controlled study was performed to that end. [13] The authors determined how much time it takes to make a decision on related treatment when POC devices were used versus traditional methods (such as sending samples to the laboratory). It was determined that average decrease in decision time was equal to 74 minutes. Such results support the idea that patient bedside testing may increase the quality of medical care and its efficiency.

Picture 4 demonstrates the differences between POC test and traditional tests. With the POC tests, lengthy periods of sample collection, transportation and laboratory test may be avoided.

In the article Технологии Point of care в клинике неотложных состояний [9] (Point of care technologies in emergency clinic setting, 2013) I. Dementyeva et al. review positive features of POC systems and provide comparative data regarding time spent for different test methods:

Examination or test performed	Time of analysis, min		Time difference, min (%)
	Central laboratory	POC test
Urinalysis	40	4	-36 (90)
Chorion gonadotropine in urine	78	5	-73 (94)
Blood glucose	10	6	-4 (60)
Cardiac biomarkers	110	17	-93 (85)
Average	59.5	8	-51.5 (87)

Therefore, POC devices have some benefits compared to central lab. Let`s highlight the main ones:

• Immediate delivery of results, i.e. no need for transportation of the sample to the central lab.
• Use of portable equipment, usually specialized for certain test, which therefore can be executed immediately in the ICU.
• Use of small amount of whole blood, excluding the need for sample pretreatment.
• Possibility to process a flow of patient simultaneously with their examination by healthcare professional, or immediately at the bedside if the patient is in critical condition.

However, some data [14] do not indicate that use of POC results in overall decrease of length of patient’s stay in ICU. Also, there was no proof that use of POC increases ICU throughput.

One shall also note that there is acute need in completion of State standards of POC test development and use, since poor quality of such devices or lack of adherence to common sanitary precautions when operating such device may result in severe negative outcomes. For example, there is a risk of infection of the ICU personnel with resistant pathogens, which may further add to the spread of nosocomial infections. There were several cases reported when ICU personnel was infected with viral hepatitis during blood glucose monitoring in patient using POC device. [15]

Notes

1. Cardiac markers are substances (molecules) which levels are rapidly and significantly increases in the blood in case of cardiac disease. Test for cardiac markers is usually requested in case of suspected acute coronary syndrome (chest pain and tachycardia), as the diagnostic aid.

References

1. Point-of-care testing [Electronic resource]. URL: https://en.wikipedia.org/w/index.php?title=Point-of-care_testing&oldid=1064905210

2. Understanding Point-of-Care Testing. 2021. URL: https://www.youtube.com/watch?v=dIUaIuF4Tts

3. Briefing. In vitro diagnostic medical devices (2014) [Electronic resource]. URL: https://www.europarl.europa.eu/thinktank/en/document/EPRS_BRI(2014)542151

4. Price C.P. Regular review: Point of care testing // BMJ : British Medical Journal. BMJ Publishing Group, 2001. V. 322, № 7297. pp. 1285.

5. Sackett D.L. и др. Evidence based medicine: what it is and what it isn’t // BMJ. 1996. V. 312, № 7023. pp. 71–72.

6. Kolsanov A.V. i dr. Ekspress-metody opredeleniya pokazatelej metabolizma v rotovoj zhidkosti (obzor literatury) // Klinicheskaya laboratornaya diagnostika. Rossiya, Moskva: OAO «Izdatel’stvo «Medicina», 2018. V. 63, № 8. pp. 489–495.

7. Ponomarev G.V. i dr. GLUTAMATNYE BIOMARKERY V KOMPLEKSNOJ DIAGNOSTIKE OSTROJ I HRONICHESKOJ ISHEMII GOLOVNOGO MOZGA // Annaly klinicheskoj i eksperimental’noj nevrologii. Rossiya, Moskva: Federal’noe gosudarstvennoe byudzhetnoe nauchnoe uchrezhdenie «Nauchnyj centr nevrologii», 2020. V. 14, № 4. pp. 15–22.

8. Timofeev A.V. Izmerenie glyukozy po mestu lecheniya: voprosy kachestva i bezopasnosti Soobshchenie 1. Klassifikaciya i analiticheskie harakteristiki metodov izmereniya glyukozy // Endokrinologiya: Novosti. Mneniya. Obuchenie. Rossiya, Moskva: Obshchestvo s ogranichennoj otvetstvennost’yu Izdatel’skaya gruppa «GEOTAR-Media», 2014. № 1/2 (6). pp. 38–46.

9. Dement’eva I.I. i dr. Tekhnologii point of care v klinike neotlozhnyh sostoyanij // Klinicheskaya laboratornaya diagnostika. Rossiya, Moskva: OAO «Izdatel’stvo «Medicina», 2013. № 7. pp. 5–10.

10. Ergeshovich E.A., Nikolaevna CH.L., Nikolaevna A.S. NOVYE TEKHNOLOGII DIAGNOSTIKI LEKARSTVENNO-USTOJCHIVOGO TUBERKULEZA // Vestnik Rossijskoj akademii medicinskih nauk. Rossiya, Moskva: Obshchestvennaya organizaciya «Soyuz pediatrov Rossii», 2019. V. 74, № 6. pp. 413–422.

11. Point-of-care testing (POCT): Current techniques and future perspectives // Trends Analyt. Chem. Elsevier, 2011. V. 30, № 6. pp. 887–898.

12. Anders Larsson, Roman Greig-Pylypczuk & Albert Huisman (2015) The state of point-of-care testing: a european perspective, Upsala Journal of Medical Sciences, 120:1, 1-10. URL:

https://doi.org/10.3109/03009734.2015.1006347

13. Kendall J., Reeves B., Clancy M. Point of care testing: randomised controlled trial of clinical outcome // BMJ. 1998. V. 316, № 7137. pp. 1052–1057.

14. Parvin C.A. и др. Impact of point-of-care testing on patients’ length of stay in a large emergency department // Clinical Chemistry. 1996. V. 42, № 5. pp. 711–717.

15. Greyson J. Quality control in patient self-monitoring of blood glucose // Diabetes Care. 1993. V. 16, № 9. pp. 1306–1308.