Framtiden for pasientnær analysering utenfor sykehus

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1 Framtiden for pasientnær analysering utenfor sykehus Sverre Sandberg Professor, leder Noklus BFI 15. april Norsk kvalitetsforbedring av laboratorievirksomhet utenfor sykehus

2 POCT is the fastest growing field in laboratory medicine ü Der er mange sykehus ü Der er flere avdelinger, legekontor, sykehjem, hjemmetjensteenheter ü Der er flere pasienter ü Der er flere friske personer

3 Future of the Laboratory World Automation / Core labs Point of Care Testing Laboratories for special analyses

4 Jani IV, Peter TF. N Engl J Med. 2013;368:

5 The first generation of point-of-care testing relies on easy-to-detect biomarkers, such as antibodies, antigens (HCG, infectious mononucleosis), and simple biochemical reactions (HbA1c, glucose, CRP, INR).

6 On the horizon Tests that can detect nucleic acids and cell-surface markers. The first applications of these technologies have e.g. included enumeration of CD4+ T cells, and drug-resistance screening. Thereafter lab on a chip devices, smaller devices, simpler to operate and potentially instrument free, enabling reliable home-based testing or self-testing.

7 Det vil være mulig å ugøre de aller fleste analyser pasientnært. Spørsmålet blir ikke om det er mulig, men om det er ønskelig!!

8 Det viktigste spørsmålet i laboratoriemedisin To use or not to use a test - Og hvis svaret er ja til bruk av en test - PÅ HVILKET NIVÅ SKAL DEN BRUKES?

9 Point-of-care testing can have a transformative effect on health care. especially in the developing world and remote areas Fire av de vikkgste sykdommene i verden: - HIV - Malaria - Tuberculosis - HepaKKs B

10 HIV rapid tests Rapid HIV tests increases the rates of case finding since you can meet the patients where they are, and in high prevalence countries they should be tested repeatedly over the course of their lives. De Cock KM et al. N Engl J Med 2006;354: Sør Afrika:

11 Effect of CD 4 cellcounkng Total loss to follow- up before inikakon of ankretroviral treatment fell from 64% to 33% The median Kme from enrolment to ankretroviral therapy inikakon reduced from 48 days to 20 days primarily because of a reduc,on in the median,me taken to complete CD4 staging, which decreased from 32 days to 3 days. Jani IV et al. Lancet 2011;378:

12 Malaria rapid tests Malaria rapid tests have successfully raised testing rates in Africa for suspected cases from below 5% in 2000 to 45% in 2010 thereby reducing inappropriate antimalaria treatment and improving community-based management of fever and health outcomes. Test treat track scaling up diagnostic testing, treatment and surveillance for malaria ( test_treat_track/en/ index.html). Geneva: World Health Organization.

13 Tuberculosis Rapid, cost-effective rapid testing for tuberculosis have increased the rate of case detection by up to 50% and reduced the time until treatment initiation by a factor of 10 Boehme CC et al. Lancet 2011;377:

14 However, the benefit of new point-ofcare tests cannot be taken for granted. THEREFORE Innovation will be needed in the design, operation, and workflow of health care to ensure that testing is accessible and results are used in real time to guide treatment. Point-of-care testing may lengthen clinic visits and place extra demands on staffing and space.

15 POC instruments outside the hospital What are the physicians and the patients interested in? - Which constituents that shall be analysed. - That the results are correct. - To have someone to consult with when something goes wrong. - Advices about what instruments to use. - Correct interpretations of the results.

16 Norsk kvalitetsforbedring av laboratorievirksomhet utenfor sykehus - Noklus Ca 100 ansa[e (70 bioingeniører, 20 lab.leger) Midler fra Staten og Den Norske Legeforening Totalt 2855 deltakere 1725 (99,8 %) legekontor deltar graks 848 (96 %) sykehjem deltar Kl selvkost Stort prosjekt mot hjemmetjeneste Andre: legevakt, oljeplacormer, militære installasjoner, bedridshelsetjenester, sykehus, skoler 60 % av deltakere ble besøkt i kurs med 5254 deltakere i EKV- programmer

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18 Noklus Kurs og veiledning Ekstern kvalitetssikring Skandinavisk evaluering av laboratorieutstyr i primærhelsetjenesten SKUP Egenkontroll av INR Klinisk bruk av laboratoriet sykehistorier Norsk diabetesregister for voksne Forskning og utvikling

19 U- albumin Clin Chem Lab Med 2015; 53(1):45-51

20 Hjemmetjeneste Betydelig volum av CRP, urinstrimmel, INR og glukose samt taking og forsendelse av andre prøver Uklart hvem som rekvirerer prøvene Uklart hvem som får prøvesvar Uklart hvor prøvesvarene arkiveres

21 Self-measurements INR, glucose, creatinine and.. It is about patient empowerment INR: Strong evidence (e.g. Cochrane reviews) showing that selfmeasurement and dosing gives better results than ordinary practice. Glucose: Much weaker evidence, especially in type II patients

22 Kidney transplant patients Results are loaded into a web page and automatic feed-back is given dependent on the results and trend analyses. Patient empowerment!!

23 Decentralized at the Pharmacy?? Who Who has the has responsibility? the responsibility?

24 Self-measurement Home testing

25 This can facilitate the empowerment of the patients But who looks after the quality 25

26 Who is evaluating POC instruments? What is missing in the EU is an independent institution that performs regular and critical evaluation of the quality of devices before and also after their market approval. Heineman et al. J Diabet Technol 2013; 7: 1-6

27 Kvalitetssikring i bredt perspektiv Hvilke analyer bør gjøres hvor? Hvilke instrumenter er egnet? I drift Hvordan identifisere pasienter Prøvetaking Stabilitet Rapportering Tolkning Aksjoner

28 Derfor selv om vi har instrumenter med god kvalitet The benefit of new point-of-care tests cannot be taken for granted. Health systems have been designed around diagnostic testing performed in the laboratory and are not well adapted to the use of point-of-care testing (neither are we). The coming wave of such technologies therefore demands changes to health systems.

29 Testing policies need to be updated. The World Health Organization (WHO) and other normative bodies should provide recommendations on how to use point-of-care tests (including guidance on risks, benefits, cost- effectiveness and quality assurance), how to select the right products, and where and how to apply new technologies in relation to existing tests.

30 Framtiden: Vi må kunne svare på følgende vesentlige POC spørsmål før vi starter - utkomme: Er det nyttig for pasienten? - politisk: Hvem bestemmer? - organisatorisk: Hvor skal det gjøres? - økonomisk: Har vi råd til det? - analysekvalitet: Har vi et system for å sikre god analysekvalitet?

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