Transcript Point of Care Testing (POCT)

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
POCT Terminology
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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
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환자 자신, 간호사, 의사, 임상병리사 등등 훈
련 받은 사람은 누구나 가능
병실, 중환자실, 응급실, 신생아실, 수술실, 엠
블란스, 의원, 헌혈의 집, 학교양호실, 스포츠
센터, 전쟁터, 가정, 등등
POCT 성장발전 과정
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혈액, 화학, 미생물검사로서 중요성
병원검사실이 지역사회로 확대 발전
분산검사실(decentralized/distributed
laboratories) 추이 : 제3의 물결
미국 혈당검사 50% 이상이 가정에서 시행
되고, hCG ?
POCT 시장 판도
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H. pylori, Streptococcus group A
Ovulation test, Urine hCG
Cholesterol, Fecal/gastric occult blood,
Glucose, 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
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Faster decision making
Starting treatment earlier
Improved adherence to
treatment & Reduced
incidence of complications
Quicker optimisation
Reduced reoperation or
readmission rate
Patient satisfaction
Chest pain, drug overdose
Drug overdose
Diabetes
Anticoagulation
Parathyroidectomy
Fewer journeys, ownership of
disease
POCT - 재택검사의 성공 사례
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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
anticoagulant therapy)
POCT - 응급실에서 실태
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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
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MULTISTIX® 10 SG Reagent Strips
1) Distinguishes between hemolyzed and intact RBCs
2) Chemistries : leukocytes, glucose, Bilirubin, Ketone,
specific gravity, nitrite, ph, protein, Urobilinogen, blood
3) Automatic urine color determination
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CLINITEK® hCG Urine Test Strips
CLINITEK® Microalbumin Reagent Strips
Implantable Home-use Glucose Sensor
(MiniMed’s Continuous Glucose Monitoring System)
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FDA : PMA (Feb.26,’99)
SC, interstitial fluid
4 - 6 x for three days
for acute adjustment
On-Site Alcohol Testing
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Saliva/urine
In 2 min.
“+” : >0.02%
Cardiac
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Troponin I
CK-MB
Myoglobin
Troponin T
Coagulation -POCT
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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
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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
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Na,K,Cl,Ca++, pH,pCO2,pO2
O2-sat, Total CO2, HCO3 BUN, Glucose, Hct, Hb,
IRMA Blood Analysis System
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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
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Glucose, TG, Creatinine
Cholesterol, TG, CK, Hb,
AST, ALT, GGT, Urea
Uric acid, ALP, Bilirubin
Piccolo®
Point-of-Care Chemistry System
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Fast, accurate test results take the guesswork out of on-thespot 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
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Point-of-Care Screening for Chromosomal
Anomalies in the First Trimester of Pregnancy
pretest counseling
with a midwife
counselor
free ß-hCG and PAPP-A
Using rapid homogeneous immunoassay
ultrasound imaging techniques
95% detection rate
for 2% screen-positive rate
chorionic villus sampling
could be scheduled
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Maternal age, MSAFP & ß-hCG
One-stop clinic
POCT Network
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검사장소, 환자 가정, 병원, 주치의, 수납, 응급실,
응급 이동팀, 투석실, 물품 공급실, 검사실, 단골의사
POCT 누가 원하는가? (Bickford GR, 1994)
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의사
임상병리과
간호사
행정
환자
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37%
34%
18%
11%
<1%
POCT 장점 (Bickford GR, 1994)
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시간단축 (TAT)
환자 만족
진료일수 감소
눈에 보인다
비용절감
검사실 보완
개별의뢰가능, 수입,
QC, 정밀, 정확---
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91%
34%
21%
17%
15%
14%
: <10%
Some examples of economic outcomes from
use of point of care testing
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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
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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
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(Bickford GR, 1994)
정확도 감소
QC/calibration 문제
교육 요구가 많다
정밀도가 낮다
비용 과다
개별 의뢰 남용
수입 부정확
가시성, 환자만족, TAT
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73%
58%
58%
57%
46%
39%
22%
<10%
POCT 추진
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Creating effective POCT programs, open
communication, brain storm, common goal,
compromise
POCT Department, Committee
POCT coordinator, team
POCT 조직
임상병리 전문의의 역할
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POCT 위원회
POCT 범위
기기 /방법 선정
교육
QC/신임 팀 지도
각과/간호 조정
POCT- QA/Acreditation
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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,
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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,
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COLA
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Basic requirements :
(Commission on Office Laboratory Accreditation): registration,
manufacturer instruction
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
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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
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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