VOLUME NO.25

Towards Excellent Customer Service • Utas Maju Sdn Bhd Newsletter

AcuteMyocardial

Infarction

OUREDITORIAL

TEAM

A NOTE FROM OUR

EDITOR

EIDULFITRISPEECHFROM OUR MD

Assalamualaikum W.B.T

Acute Myocardial Infarction (AMI) - also known as heart

attack; continues to be a major health problem for Malaysians

due to more sedentary lifestyle compared to past years,

with increasing trends of hypertension, diabetes, obesity

and hyperlipidemia. Brisk News 25th highlights this new

topic to share the disease knowledge and the diagnosis

method available for use.

Also, we published the fi nal part of QC Management‘s article - discussing about

error in medical laboratory written by Senior Science Offi cer Penang General

Hospital; as well as events organized with our Key Partners.

Last but not least, we wish to all Muslim the most blessing, barokah and

forgiveness during the special month of this Ramadhan 1436H.

Zamzani SyaifulChief Editor • Brisk News

Assalamualaikum dan Salam Sejahtera.

Alhamdulilah. Mari kita panjatkan kesyukuran kepada Allah S.W.T diatas

kesempatan menikmati Ramadhan dan Syawal yang penuh barokah ini.

Saya doakan kesemua amal kita diterima Allah dan menjadikan kita insan

yang hebat di sisi-Nya.

Tahun 2015 datang dengan pelbagai cabaran baru seperti pengenalan

GST dan penguatkuasaan Medical Device Act, namun kami di Utas Maju

menanggapinya sebagai peluang untuk terus berkembang. Ruang kerjasama

yang diberi oleh para pelanggan selama lebih 12 tahun – membolehkan kami

sentiasa bersaing di dalam pasaran yang begitu dinamik. Bahkan, kami

telah meletakkan kerjasama ini sebagai salah satu nilai teras perniagaan

kami dan sentiasa menganggap para pelanggan sebagai Rakan Strategik.

Secara peribadi, saya berharap agar kerjasama ini terus terjalin dalam

kerangka yang membina khususnya perkongsian pengetahuan,

perkembangan teknologi, penyelidikan, pengurusan organisasi dan

pembangunan sumber manusia - ke arah mencapai visi dan misi

kesihatan negara kita. Kami amat menggalakkan para pelanggan untuk

terus menyampaikan maklumat kepada kami bagi menyelesaikan segala

permasalahan dan memenuhi sebarang keperluan di makmal diagnostik.

Kita perlu terus sama-sama fokus kepada peningkatan kualiti servis makmal

melalui perkhidmatan yang efektif dan efi sien.

Akhir kata, saya mewakili warga Utas Maju ingin mengambil kesempatan

untuk memohon maaf atas segala kekurangan dan salah silap sepanjang

kita berurusan dan berhubungan selama ini. Semoga kehadiran Eidulfi tri kali

ini mengeratkan hubungan kita sesama insan dan terlebih utama hubungan

kita dengan Allah Yang Maha Esa.

“Minal Aidil Wal Faizin”

Adnan Md NohPengarah Urusan • Utas Maju Sdn. Bhd.

ADVISOREn. Adnan Md Noh

En. Ahmad Khusyairi Zubir

CHIEF EDITORZamzani Syaiful

ASSISTANT EDITOR & MARKETINGAtiqah Zulme

CONTRIBUTING EDITORAmen Fadzly Rahmat Ahmad

Nur Murhasuani Murad

MEDIAAhmad Athar Mohd Yusoff

DESIGNERPlum Rose & Thorn Advertising

CONTENTS3 Acute Myocardial Infraction

4 Error in Medical Laboratory

6 AccuTnI Peer-reviewedPublication

8 Event Highlights

BRISK NEWS • VOLUME NO. 25 • 3

Myocardial infarction (MI) or Acute Myocardial Infarction (AMI) also known as a heart attack, happen when blood

fl ows stops to part of the heart causing damage to the heart muscle. According to the 3rd Universal Defi nition

of Myocardial infarction, the term AMI should be used when there is evidence of myocardial necrosis in a clinical

setting consistent with acute myocardial ischemia. MI is defi ned in pathology as myocardial cell death due to

prolonged ischaemia. Cardiovascular disease remains an important cause of death in Malaysia accounting for

20-25% of all deaths in government hospitals from 2000 - 2005. Following an acute myocardial infarction (AMI)

the mortality rate was about 20% in 2004. This high rate could have been due to late presentation and diagnosis,

leading to delayed treatment. Occasionally the diagnosis could have been missed. In developed countries the

mortality rate following an AMI had decreased to less than 9%

by the early 2000’s. Myocardial infarction (MI) can be recognized

by clinical features, including electrocardiographic (ECG)

fi ndings, elevated values of biochemical markers (biomarkers)

of myocardial necrosis, and by imaging, or may be defi ned by

pathology. It is a major cause of death and disability worldwide.

MI may be the fi rst manifestation of coronary artery disease

(CAD) or it may occur, repeatedly, in patients with established

disease. The sign and symptoms in MI usually gradual, over

several minutes, and rarely.

Biomarker detection of myocardial injury with NecrosisMyocardial injury is detected when blood levels of sensitive and

specifi c biomarkers such as cTn or the MB fraction of creatine

kinase (CKMB) are increased. Cardiac troponin I and T are

components of the contractile apparatus of myocardial cells and

are expressed almost exclusively in the heart. Although elevations of these biomarkers in the blood refl ect injury

leading to necrosis of myocardial cells, they do not indicate the underlying mechanism. The preferred biomarker-

overall and for each specifi c category of MI-is cTn (I or T), which has high myocardial tissue specifi city as well as

high clinical sensitivity. Detection of a rise and/or fall of the measurements is essential to the diagnosis of acute

MI.An increased cTn concentration is defi ned as a value exceeding the 99th percentile of a normal reference

population [upper reference limit (URL)]. This discriminatory 99th percentile is designated as the decision level

for the diagnosis of MI and must be determined for each specifi c assay with appropriate quality control in each

laboratory. Values should be presented as nanograms per litre (ng/L) or picograms per millilitre (pg/mL) to make

whole numbers. Criteria for the rise of cTn values are assay-dependent but can be defi ned from the precision

profi le of each individual assay, including high-sensitivity assays.

AcuteMyocardial

Infarction

4 • BRISK NEWS • VOLUME NO.25

Figure 2 : The real value of biomarkers such as troponin lies in the diagnosis

and prognosis of NSTEMI

The clinical utility of cardiac troponin continues

to evolve as assays constantly improve. Since

the introduction of the fi rst diagnostic cardiac

troponin test in 1996, assay improvements have

been quickly followed by changes in utility due to

the unique sensitivity and specifi city of cardiac

troponin for cardiac injury. These changes in

utility have directly impacted the evolution of

myocardial infarction (MI) defi nitions, driving

towards earlier diagnosis of MI and improved

patient outcomes. AccuTnI has contributed

to this rich history through several hallmark

publications; with AccuTnI+3, advances will continue. With the initial

introduction of cardiac troponin, the excitement was for a more specifi c

marker to replace CKMB. The current thinking is that one day, troponin

will play a role in preventive medicine as a more defi nitive indicator of

subclinical cardiovascular disease. Beckman Coulter is dedicated to

advancing this research by participating in early studies with a prototype

high-sensitivity TnI assay and now developing a high sensitivity troponin

assay to be commercially available in the future.

References:

Jennings RB, Ganote CE. Structural changes in myocardium during acute ischemia. Circ Res. 1974; 35 Suppl 3: 156–172

Thygesen K, Alpert JS, White HD, Joint ESC/ACCF/AHA/WHF Task Force for the Redefi nition of Myocardial Infarction. Universal

defi nition of myocardial infarction. Eur Heart J. 2007; 28: 2525–2538; Circulation. 2007;116:2634–2653; J Am Coll Cardiol.

2007;50:2173–2195

Jaffe AS, Babuin L, Apple FS. Biomarkers in acute cardiac disease. J Am Coll Cardiol. 2006; 48:1–11

The Joint European Society of Cardiology/American College of Cardiology Committee. Myocardial infarction redefi ned

— A consensus document of the Joint European Society of Cardiology/American College of Cardiology Committee

for the redefi nition of myocardial infarction. Eur Heart J. 2000; 21:1502–1513; J Am Coll Cardiol. 2000;36:959–969

Article by: MUHAMMAD ARIFF BIN ZAINOL • Application Specialist for Utas Maju Sdn Bhd

Beckman Coulter Access AccuTnI+3 Cardiac Solution

Acute MyocardialInfarction

BRISK NEWS • VOLUME NO. 25 • 5

ERRORS INMEDICALLABORATORY

The understanding of errors in analytical laboratory is fundamental for troubleshooting of the internal

quality control. This is important to save time, to be cost effective and provide excellent service in

a medical laboratory.

Two type of errors in medical laboratory are systematic error and random error.

The random error is error in measurement that lead to measurable values being inconsistent when

repeatable measures of a constant attribute or quantity are taken.

Systematic Error

Random Error

The systematic error is the errors that always cause the measurement to diff er from the truth in the same way(i.e. the measurement is always larger or always smaller, than the truth.)

6 • BRISK NEWS • VOLUME NO.25

Article by: MR. SAIRI SATARI • Senior Biochemist for Penang Hospital

Systematic and random errors always occur in daily IQC. The acceptance of errors in an analytical

laboratory depend on our specifi cation of quality performance.

Understanding the causes of systematic and random errors are very important to solve the daily IQC

problems which would involve duration,cost effectiveness and excellence of service.

The cause of random errors are:

• Bubbles in reagents and reagent lines,

• Inadequately mixed reagents,

• Unstable temperature and incubation

• Unstable electrical supply, and

• Individual operator variation in pipetting, timing, etc

The cause of systematic errors are:

• Change in reagent lot

• Change in calibrator lot.

• Wrong calibrator values

• Improperly prepared reagents

• Deterioration of reagents

• Deterioration of calibrator

• Inadequate storage of reagents or calibrators

• Change in sample or reagent volumes due to pipettor misadjustment or misalignment

• Change in temperature of incubators and reaction blocks

• Deterioration of a photometric light source, and

• Change in procedure from one operator to another

IQC troubleshooting should focus on the type of error. The Levey Jennings chart and the Westgard

rules will provide us the information of the error. All the daily IQC shall be plot on the Levey Jenning’s

chart and analysed by Westgard rule to determine the error.

For the chemistry analysis, we generally use 2 levels of the control material which are analysed

simultaneously. Six rules are used to identifi ed types of error whether random error or systematic

error. The six rule are 12s, 13s, 22s, R4s, 41s and 10x [The Westgard Rule]

The Westgard rule will help us determine the type of error as the table below;

Type of Errors Westgard Rule

Systematic 22s,41s and 10x

Random 12s,13s and R4s

In conclusion, the cause of error

determines the type of error.

Understanding of Westgard

Rule will help us to perform the

troubleshooting of daily IQC.

The Summary of the Westgard Rule

BRISK NEWS • VOLUME NO. 25 • 7

IMPROVED DIAGNOSIS OF M1. Value of cardiac troponin I cutoff concentrations below

the 99th percentile for clinical decision-making. Eggers KM, Jaffe AS, Lind L, Venge P, Lindahl B. Clin Chem

2009;55:85-92.

• The authors selected the Access AccuTnI assay to evaluate factors

infl uencing the 99th percentile upper reference limit (URL) for healthy

individuals.

• The 99th percentile of cTnI depends highly on the characteristics of

the reference population from which it is determined. This dependence

on the reference population may affect the appropriateness of clinical

conclusions based on this threshold.

• However, cTnI cutoffs below the 99th percentile seem to provide better

prognostic discrimination in stabilized acute coronary syndrome

patients and therefore may be preferable for risk stratifi cation.

• This publication suggests that different cut-offs might be used in the

future for AMI diagnosis and risk stratifi cation of ACS patients,

respectively.

2. Assessing the requirement the 6-hour interval between

specimens in the American Heart Association

classifi cation of myocardial infarction in epidemiology

and clinical research studies.

McRae AR, Kavsak PA, Lustig V, Bhargava R, Vandersluis R, Palomaki GE,

Yerna M-J, Jaffe AS. Clin Chem 2006;52:812-818.

• This study suggests that the AHA six-hour requirement between serial

troponin measurements can be shortened using the Access AccuTnI

assay for cTnI measurement. In other words, the Access AccuTnI can

enable two specimens in a three-hour period and hence cut triage time

in half.

• Reduction in triage time is directly related to the exquisite clinical

sensitivity of the Access AccuTnI assay.

3. The impact of the ESC/ACC redefi nition of myocardial

infarction and new sensitive troponin assays on the

frequency of acute myocardial infarction.

Kavsak PA, MacRae AR, Lustig V, Bhargava R, Vandersluis R, Palomaki GE,

Yerna M-J, Jaffe AS. Am Heart J 2006;152:118-125.

• This study shows the importance of using the contemporary cut-off

(99th percentile URL) for AMI diagnosis, which provides an opportunity

for earlier patient intervention.

• High sensitivity and great precision at the low end of the assay range

are key elements for achieving success with these new guidelines.

• AccuTnI is shown in this study to fulfi ll the sensitivity and robustness

criteria required to meet the 2000 ESC/ACC Guidelines.

IMPROVED PATIENT CARE4. Troponin I as a predictor of coronary heart disease and

mortality in 70-year-old men.

Zethelius B, Johnston N, Venge P. Circulation 2006;113:1071-1078.

• This is the fi rst study to show that a slightly elevated cTnI concentration,

measured with the Access AccuTnI assay in men free from CVD at

baseline or with prevalent CVD at baseline, is associated with an

increased risk of fi rst event (mortality or coronary heart disease event)

over a follow-up period of 10 years.

• This association is independent of conventional cardiac heart-disease

risk factors (hypertension, cholesterol, etc.)

• The excellent clinical sensitivity of the Access AccuTnI assay is thought

to be the major driver to the association described above.

5. Persistent cardiac troponin I elevation in stabilized

patients after an episode of acute coronary syndrome

predicts long-term mortality.

Eggers KM, Lagerqvist B, Venge P, Wallentin L, Lindahl B. Circulation

2007;116:1907-1914.

• Persistent minor cTnI elevation can be detected frequently in patients

stabilized after an episode of non-ST-elevation acute coronary

syndrome with the use of a sensitive assay, such as AccuTnI.

• Elevated cTnI levels > 0.01 µg/L predict mortality during long-term

follow-up.

6. Early and late outcome prediction of death in the

emergency room setting by point-of-care and laboratory

assays of cardiac troponin I assay.

Venge P, Ohberg C, Flodin, M, Lindahl B, Am Heart J 2010;160:835-841.

• Troponin results were compared using death in early (14 days) and late

follow-up (median 3.3 months).

• The central laboratory assays identifi ed more patients with elevated

troponin results, compared to the POC assays.

• At their respective 99th percentile upper reference limits, AccuTnI

identifi ed 88% and Architect cTnI identifi ed 81% of all patients who

died of cardiovascular disease as compared with 50% and 54% for

i-Stat and Stratus CS, respectively.

• The Access AccuTnI assay shows high clinical sensitivity, high NPV,

and outperforms the POC assays with respect to identifying patients

at risk of death from CVD.

7. Clinical performances of two highly sensitive cardiac

troponin I assays. Venge P, James S, Jansson L, Lindahl B. Clin Chem 2009;55:109-116.

• Signifi cant differences seen in the Centaur TnI-Ultra vs. the Access

AccuTnI assay capacity to identify patients at risk of premature death

or death/MI.

• The Access AccuTnI demonstrated overall superior clinical sensitivity.

• “We conclude from this study that when using comparable cutoffs,

the AccuTnI assay identifi ed more patients at risk of premature death

in cardiovascular disease than the Centaur TnI Ultra assay.”

8. Health outcomes categorized by current and previous

defi nitions of acute myocardial infarction in an unselected

cohort of troponin-naïve emergency department

patients. Kavsak PA, MacRae AR, Palomaki GE, Newman AM, Ko DT, Lustig V,

Tu JV, Jaffe AS. Clin Chem 2006;52:2028-2035.

• Early AccuTnI elevations at patient presentation are prognostic.

• Different levels of risks are associated with different AccuTnI cut-offs.

AccuTnIPeer-Reviewed Publication

8 • BRISK NEWS • VOLUME NO.25

Utas Maju Sdn BhdNo.15, Block H, Jalan PJU 1A/3, Taipan 2 Damansara, Ara Damansara47301 Petaling Jaya, Selangor, MALAYSIA

www.utasmaju.com.my

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EVENTS Compilations by: Atiqah Binti ZulmeMarketing Executive for Utas Maju Sdn Bhd

Beckman Meeting @ BaliIndonesia, 20th & 21st January 2015, Beckman Coulter has conducted the 2015 SEA/Korea Diagnostic Regional Distributor’s Meeting that was held in Bali, Indonesia. With the theme “Up to Win”, all distributors join the discussion together and share their planning strategies and experiences on how things are diff erent at each region.

Sebia Advanced Protein Electrophoresis SeminarIMR Kuala Lumpur, 25th March 2015, Utas Maju has invited the representative from principle Sebia to provide knowledge and skill in diagnosing and monitoring of protein disorders using gel and capillary electrophoresis system at Sebia Advanced Protein Electrophoresis Seminar. UMSB also invite speaker clinicians from Ampang, Dr Baizura and Dr Veena to share knowledge and skill in interpretation results for advanced protein analysis.

CME Diagnostic Confi dence in ACS Management with AccuTnI+3,Hos. Kuala Lumpur, March 25th 2015, Beckman Coulter Malaysia together with Utas Maju has conducted the Lunch Talk CME at Medical Department HKL. With the title on Diagnostic Confi dence in ACS Management with AccuTnI+3, representative from Beckman Coulter , Dr Lindsay has introduce the latest myocardial infarction and describing the application of troponin I in acute coronary syndrome management. This event was attend by participants Medical Offi cer from Medical Department, Pathologist and Clinicians.