Point of Care Testing (POCT)

References

Kendall J, Reeves B, Clancy M. Point of care testing: randomised controlled trial of clinical outcome. BMJ 1998;316:1052-1057

Spencer K. Point-of-care screening for chromosomal anomalies in the first trimester of pregnancy. Clin Chem 2002;48:403-404

Scott MG. Faster Is Better—It’s Rarely That Simple! Clin Chem 2000;46:441-442

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POCT Terminology Near patient testing Bedside testing Extra laboratory testing

Alternate site testing Physician office testing Out-off-laboratory testing Patient-focused laboratory testing Decentralized testing

Point of Care Testing (POCT)

중앙화된 검사실 외에서 이루어지는 검사

POCT 어디에서 이루어지는가

환자 자신 , 간호사 , 의사 , 임상병리사 등등 훈련 받은 사람은 누구나 가능

병실 , 중환자실 , 응급실 , 신생아실 , 수술실 , 엠블란스 , 의원 , 헌혈의 집 , 학교양호실 , 스포츠센터 , 전쟁터 , 가정 , 등등

POCT 성장발전 과정 혈액 , 화학 , 미생물검사로서 중요성 병원검사실이 지역사회로 확대 발전 분산검사실 (decentralized/distributed labo

ratories) 추이 : 제 3 의 물결 미국 혈당검사 50% 이상이 가정에서

시행되고 , hCG ?

POCT 시장 판도

H. pylori, Streptococcus group A Ovulation test, Urine hCG Cholesterol, Fecal/gastric occult blood, Glu

cose, HbA1c, HDL-cholesterol, Microalbumin, TG, Fructosamine

H. pylori antibody, EBV antibody Hct, Hb, PT, APTT, ESR Urinalysis

Some examples of improved clinical outcomes from using POCT

Faster decision making Starting treatment earlier Improved adherence to tre

atment & Reduced incidence of complications

Quicker optimisation Reduced reoperation or re

admission rate Patient satisfaction

Chest pain, drug overdose

Drug overdose

Diabetes

Anticoagulation

Parathyroidectomy

Fewer journeys, ownership of disease

POCT - 재택검사의 성공 사례

Pregnancy test, glucose monitors, ovulation tests Gestational diabetes ColoCARE home test for precancerous colon polyp Hereditary hemochromatosis (MSU DNA lab) CoaguCheck system (prothrombin time for oral ant

icoagulant therapy)

POCT - 응급실에서 실태

Pregnancy : ectopic pregnancy, pre-op. Glucose : hypo-/hyperglycemia Urinalysis : patient status Metabolic : acid base balance Toxicology : drug abuse Cardiac marker : chest pain

Clinitek® 50 Analyzer

MULTISTIX® 10 SG Reagent Strips

1) Distinguishes between hemolyzed and intact RBCs 2) Chemistries : leukocytes, glucose, Bilirubin, Ketone, speci

fic gravity, nitrite, ph, protein, Urobilinogen, blood 3) Automatic urine color determination

CLINITEK® hCG Urine Test Strips CLINITEK® Microalbumin Reagent Strips

Implantable Home-use Glucose Sensor (MiniMed’s Continuous Glucose Monitoring System)

FDA : PMA (Feb.26,’99) SC, interstitial fluid 4 - 6 x for three days for acute adjustment

On-Site Alcohol Testing

Saliva/urine In 2 min. “+” : >0.02%

Cardiac Troponin I CK-MB Myoglobin Troponin T

Coagulation -POCT

GEM-PCL (IL Co.) : PT, APTT, ACT-LR

CoaguCheck-Pro/DM (Roche) : PT, APTT, ACT

Coumadin monitoring

RAPIDPOINT™ Coag point-of-care Coagulation Monitoring System

multitest analyzer for monitoring anticoagulation therapy and determining a patient's coagulation status at the point-of-care.

PT, APTT, & a state-of-the-art HEPARIN MANAGEMENT TEST (HMT).

HMT is a more accurate version of the activated clotting time test (ACT)

Amphetamines, Barbiturates, Benzodiazepines, Cocaine, Morphine, PCP, & THC

OnTrak Testcup ER OnTrak Teststik (Roche)

Glucose

iSTAT

Na,K,Cl,Ca++, pH,pCO2,pO2

O2-sat, Total CO2, HCO3 -

BUN, Glucose, Hct, Hb,

IRMA Blood Analysis System

Three drops of blood & results in less than two minutes

Compact and rugged, with a built-in handle for easy transport

tHb, O2Hb, MetHb, and COHb.

Dry Chemistry

Glucose, TG, Creatinine Cholesterol, TG, CK, Hb, AST, ALT, GGT, Urea Uric acid, ALP, Bilirubin

Piccolo® Point-of-Care Chemistry System

Fast, accurate test results take the guesswork out of on-the-spot diagnosis.   Treatment can begin right away.

Small sample size makes Piccolo ideal for pediatric and geriatric populations.

Portability and fast, accurate results mean patients can be tested and treated just about anywhere - including remote site, at-home

Virtually no training is required Total hands-on time is less than one minute Multi-test results are available in less than 15 minutes

Point of care haemoglobin analysis

Point-of-Care Screening for Chromosomal Anomalies in the First Trimester of Pregnancy

free ß-hCG and PAPP-AUsing rapid homogeneous immunoassay

Maternal age, MSAFP & ß-hCG One-stop clinic

ultrasound imaging techniques

pretest counseling with a midwife counselor

chorionic villus sampling could be scheduled

95% detection rate for 2% screen-positive rate

POCT Network

검사장소 , 환자 가정 , 병원 , 주치의 , 수납 , 응급실 , 응급 이동팀 , 투석실 , 물품 공급실 , 검사실 , 단골의사

POCT 누가 원하는가 ? (Bickford GR, 1994)

의사 : 37% 임상병리과 : 34% 간호사 : 18% 행정 : 11% 환자 : <1%

POCT 장점 (Bickford GR, 1994)

시간단축 (TAT) : 91% 환자 만족 : 34% 진료일수 감소 : 21% 눈에 보인다 : 17% 비용절감 : 15% 검사실 보완 : 14% 개별의뢰가능 , 수입 ,

QC, 정밀 , 정확 --- : <10%

Some examples of economic outcomes from use of point of care testing Reduced number of clinic visits Reduced length of hospital stay Earlier discharge from hospital Fewer unnecessary hospital admissions Better optimised drug treatment Less inappropriate use of drugs Reduced use of blood products Reduced use of staff, equipment, and estate Improved quality of life

Faster Is Better—It’s Rarely That Simple! Scott MG. Clin Chem 2000;46:441-442

Simply moving the point of testing from the central laboratory to the clinical service did not improve patient waiting time until significant changes in workflow were made

POCT 단점 (Bickford GR, 1994)

정확도 감소 : 73% QC/calibration 문제 : 58% 교육 요구가 많다 : 58% 정밀도가 낮다 : 57% 비용 과다 : 46% 개별 의뢰 남용 : 39% 수입 부정확 : 22% 가시성 , 환자만족 , TAT : <10%

POCT 추진

Creating effective POCT programs, open communication, brain storm, common goal, compromise

POCT Department, Committee POCT coordinator, team

POCT 조직

임상병리 전문의의 역할

POCT 위원회 POCT 범위 기기 / 방법 선정 교육 QC/ 신임 팀 지도 각과 / 간호 조정

POCT- QA/Acreditation

JCAHO (Joint Commission on Healthcare Organizations): QC each day, document for QC failure, document for competence of personnel, audit trail, method verification, accuracy, precision, reference range,

CAP (College of American Pathology): ‘ checklist 30 for POCT’, QC twice each run, method evaluation, proficiency test, calibration verification or linearity check, document for competence of personnel, audit trail, accept electronic controls,

COLA (Commission on Office Laboratory Accreditation): registration, manufacturer instruction

Basic requirements : procedure manuals, calibration every six months, QC with two levels each day, Specified control procedures, perform and document remedial action, record keeping for two years.

The Strategies for the Future

Beyond the central laboratory Consolidate all testing under the direction of the

central laboratory by POCT method/device evaluation, QC and data/revenue management

Team approach by the Committee Train-the-trainer (doctor, nurse, phlebotomist) Data management system

The total U.S. point-of-care testing (POCT) market generated revenues of $1.6 billion in 1996

Summary points

Point of care testing requires trained operators to ensure a good quality service

Testing is effective only if action taken on the result

Testing has been shown to reduce hospital stay, improve adherence to treatment, and reduce complications.

Although point of care testing is more expensive than laboratory testing, it produces wider economic benefits