laboratory investigation guidelines for chronic kidney ... guideline.pdf · chemical pathology...

Chemical Pathology DisciplineNational Pathology ServicesMinistry of Health Malaysia

Laboratory InvestIgatIon guIdeLInesFor

CHronIC KIdney dIsease and utILIsatIon oF egFr In aduLts

MiNiStry of HealtH MalaySia

OCTOBER 2012

JD005805_KULIT INVESTIGATOR ndd.indd 1 10/30/12 1:59:29 PM

Lab Investigation Guidelines for CKD and Utilisation of eGFR in Adults 2012. i

CONTENTS

FOREWORD

1. National Head of Pathology Services ............................................................ 3

2. National Head of Chemical Pathology Service .............................................. 4

THE ARTICLE

1. Introduction ................................................................................................. 7-8

2. Aim of the guidelines ...................................................................................... 9

3. Guidelines for Requesting and Reporting of eGFR ................................ 10-11

4. Standardization of Creatinine Assay, eGFR Reporting and Laboratory

Investigations of Chronic Kidney Disease (CKD) In Adults

4.1 Serum/plasma Creatinine ...................................................................... 12

4.2 Urine Albumin Creatinine Ratio (UACR) ............................................ 13

4.3 Urine Protein Creatinine Ratio (UPCR) ............................................... 14

4.4 24-Hr Urine Protein .............................................................................. 15

4.5 Creatinine Clearance (CrCl) ............................................................ 16-17

4.6 Estimated Glomerular Filtration Rate (eGFR) by Modification of Diet in Renal Disease(MDRD) ............................. 18

APPENDIX

I. Garis Panduan Permohonan dan Laporan eGFR .................................. 21-22

II. eGFR Reporting Format .......................................................................... 23

III. Table 1 : Factor That May Affect Creatinine Generation ........................ 24

IV. Table 2 : Diagnosis of Abnormal Protein or Albumin Excretion ............. 25

V. Table 3 : Staging of Chronic Kidney Disease .......................................... 26

WORKING GROUP FOR THE STANDARDISATION OF eGFR IN CKD(ADULTS) ................................................................................................... 27

REFERENCES ................................................................................................... 28

ACKNOWLEDGEMENT ..................................................................................... 29

JD005805 Kand.indd 1 10/30/12 1:49:55 PM

JD005805 Kand.indd 2 10/30/12 1:49:56 PM

FOREWORD

Lab Investigation Guidelines for CKD and Utilisation of eGFR in Adults 2012. 1

FOREWORD

JD005805 Teks 1.indd 1 10/30/12 1:50:43 PM

FOREWORD

2 Lab Investigation Guidelines for CKD and Utilisation of eGFR in Adults 2012.

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FOREWORD


The Clinical Practice Guideline (CPG) for the Chronic Kidney Disease (CKD) that was recently launched has clearly indicated the needs to standardize the formula to be adopted for eGFR (estimated Glomerular Filtration Rate) as well as to standardize reporting for eGFR (eGFR reporting format) for the whole country. The Pathology service had established a Working Group for The Standardization of eGFR in CKD for Adults from the Chemical Pathology technical group to achieve this.

Hopefully, the standardization and guidelines that has been developed will benefit the patients.

Dr.Shahnaz MuradNational Head of Pathology ServicesMinistry of Health, Malaysia.

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FOREWORD


The prevalence of chronic kidney disease (CKD) and end-stage renal disease (ESRD) is increasing worldwide. In Malaysia, the incidence and prevalence of patients with ESRD on dialysis had increased. As a consequence, the growing number of ESRD places an enormous human, economic and social burden on the healthcare system.

Early kidney disease is largely asymptomatic and patients often present late with complications of CKD. As such, targeted screening and early intervention will be necessary to reduce the burden of the disease. Primary care providers play a key role in the early identification, treatment and improving the outcome of patients with CKD. Awareness of CKD among primary care providers should be increased and they should be equipped to detect and to treat these patients, including referral to nephrologists for further management.

In the current Clinical Practice Guidelines (CPG) by the Ministry of Health (MOH), laboratory tests for detection and staging of CKD include estimated Glomerular Filtration Rate (eGFR) based on the Modification Diet of Renal Disease (MDRD) equation. Serum creatinine should be used in combination with eGFR in the assessment of renal function.

It is my hope that this guideline: “Laboratory Investigation Guidelines for Chronic Kidney Disease and Utilisation Of eGFR in Adults” will be used by MOH Pathology laboratory as a platform to help laboratorians to implement and use a standardised formula to calculate and, thus to report eGFR.

Hopefully, the reporting of eGFR by the MOH Pathology Service will further improve the detection and staging of CKD in Malaysia.

Dr. Muhammad Arif Mohd. HashimNational Head of Chemical Pathology and Head of Pathology DepartmentHospital Kuala Lumpur

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FOREWORD


THE ARTICLES

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FOREWORD


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INTRODUCTION


Chronic kidney disease (CKD) is an irreversible loss of renal function for at least three months and poses a major public health problem. The prevalence of CKD and end-stage renal disease (ESRD) is increasing worldwide. The estimated prevalence of CKD in the US was 16.8% while in Asia the prevalence ranged from 12.1% to 17.5%. In Malaysia, the incidence and prevalence of patients with ESRD on dialysis had increased from 88 and 325 per million population (pmp) respectively in 2001 to 170 and 762 pmp respectively in 2009. The increase in ESRD was largely driven by the increasing incidence of diabetic kidney disease (DKD) accounting for 58% of new patients accepted for dialysis. As a consequence, the growing number of ESRD places an enormous human, economic and social burden on the healthcare system.

Early kidney disease is largely asymptomatic and patients often present late with complications of CKD. As such, targeted screening and early intervention will be necessary to reduce the burden of the disease. Primary care providers play a key role in the early identification, treatment and improving the outcome of patients with CKD. Awareness of CKD among primary care providers should be increased and they should be equipped to detect and to treat these patients, including referral to nephrologists for further management.

The Clinical Practice Guidelines (CPG) was recently launched by the Ministry of Health (MOH) with the objectives to provide recommendations on the following:

a) Prevention and reduction in risk of developing chronic kidney disease (CKD)

b) Screening and early detection of CKDc) Treatment of early CKD to prevent its progression to end-stage renal

diseased) Reduction in risk of cardiovascular disease

Patients with early stage of CKD are generally asymptomatic. Many of such cases remain undiagnosed and later progress to ESRD. To reduce the prevalence of ESRD, effective screening and treatment methods for CKD should be established. Early detection and intervention of high risk groups may prevent the development and progression of CKD. For instance, patients with diabetes mellitus and/or hypertension should be screened at least yearly for chronic kidney disease (CKD). Screening can also be considered for high risk patients with:

a) Age >65 years oldb) Family history of stage 5 CKD or hereditary kidney diseasec) Structural renal tract disease, renal calculi or prostatic hypertrophyd) Opportunistic (incidental) detection of haematuria or proteinuriae) Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs) or

other nephrotoxic drugsf) Cardiovascular disease (CVD)

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INTRODUCTION


g) Multisystem diseases with potential kidney involvement such as systemic lupus erythematosus.

In the current CPG, laboratory tests for detection and staging of CKD include estimated Glomerular Filtration Rate (eGFR) based on the Modification Diet of Renal Disease (MDRD) equation. Serum creatinine should be used in combination with eGFR in the assessment of renal function.

For many years, serum creatinine has been routinely used in clinical practice to estimate renal function. However, it is affected by many other variables (such as age, gender, ethnicity, muscle mass and protein meal) and should not be used as an independent marker of kidney function. Furthermore, serum creatinine is not a sensitive marker of early CKD as it will rise only after a reduction of renal function by at least 50%.

Due to this limitation, other formula to estimate renal function was developed including the MDRD equation. The MDRD equation has been shown to be better than Cockcroft-Gault equation in estimating renal function. However, these equations are still dependent on serum creatinine level and thus may over-estimate (such as in amputees) or under-estimate (such as in bodybuilders) renal function when muscle mass is abnormal.

With the launching of the CPG, National Pathology Service will implement the eGFR reporting from the clinician request using the standardized request form. Hopefully, the request and reporting of eGFR will improve the detection and staging of CKD and will help with the management of the patients.

In conclusion, through the link with laboratories, the public health issues of CKD detection and management will be implemented in a uniform manner. Renal experts (such as nephrologists and pathologists) will provide the interpretive expertise to allow optimal use of the laboratory results by the users of the laboratory services. The collaborative approach can provide a template for future activities where consensus approaches driven by informed experts are preferable to patchwork local implementations at the laboratory or laboratory network level. The consistent approach optimizes the use of pathology reporting services to disseminate pathology-related health interventions as widely as possible such as this eGFR reporting.

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AIM OF THE GUIDELINES

The aims of these guidelines are to provide:

Guideline for request of eGFR1.

Guideline for collection of specimen for tests to support CKD2.

Recommended method and method interferences3.

Guideline for calculation and unit to be adopted for tests that support 4. CKD

Guideline for reporting of eGFR (format).5.

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GUIDELINES FOR REqUESTING AND REPORTING OF eGFR


1. Request form 1.1. All manual request shall use PER. PAT 301 form 1.2. Information needed • Relevant clinical history • Previous creatinine result, if available • Previous Creatinine Clearance, if available • Previous calculated eGFR result, if available

2. Only serum or plasma creatinine sample sent along with PER. PAT 301 form shall have its eGFR calculated.

3. Calculation of eGFR using previous creatinine result shall not be allowed. This is because previous eGFR result could lead to misinterpretation of the test result correlating to the current patient status.

4. Manual calculation of eGFR 4.1. eGFR can be calculated using CKD and eGFR Laboratory Tools (CELT)

software. 4.2. Transcription check shall be done.

5. Automatic calculation of eGFR via LIS 5.1. Use the adopted eGFR formula and reporting format. The formula and

reporting format should be verified by the Chemical Pathologist or designated officer prior to first time usage.

6. eGFR reporting format 6.1 The MDRD eGFR Formula is calculated in ml/min/1.73m2

175 x (Scr/88.4)-1.154 x (Age)-0.203 x (0.742 if female)

• The equation does not require weight measurement because the results are reported normalized to 1.73 m2 body surface area, which is an accepted average adult surface area.

• This equation is not applicable for African Black.

6.2 Disclaimer below shall be included in the eGFR report

LIMITATIONS OF THE MDRD eGFR The MDRD equation should not be used in some populations where it

has not been specifically validated, including: • Paediatric patients (<18 years) • Elderly patients (>70 years) • Dialysed patients • Pregnant mothers

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GUIDELINES FOR REqUESTING AND REPORTING OF eGFR

• Extremes of body habi tus ie malnutr i t ion, paraplegia, quadriplegia

• Patients with skeletal muscle disorders • Vegetarians • Patients with very rapidly changing kidney function • Patients on renally excreted drugs that have significant toxicity • Severe dehydration • Patients on medications that might interfere with the creatinine

measurement • Not suitable for drugs dosing • Incomplete essential information (age, gender, race)

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JD005805 Teks 1.indd 12 10/30/12 1:50:45 PM


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JD005805 Teks 2.indd 13 10/30/12 2:35:33 PM


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ical

end

po

ints

(C

KD

, ca

rdio

vasc

ular

di

seas

e, a

nd

mor

talit

y)

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rela

te w

ith 2

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r p

rote

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orni

ng u

rine

spe

cim

en

is p

refe

rred

.

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ando

m u

rine

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cim

en i

s ac

cept

able

if a

first

-mor

ning

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e sp

ecim

en i

s no

t av

aila

ble.

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ility

of

urin

e pr

otei

n:2–

8 °C

: s

tabl

e up

to

7 da

ys•

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en a

t -2

0°C

: s

tabl

e up

•

to 1

yea

r

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erab

ly a

naly

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resh

sa

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ility

of

urin

e cr

eatin

ine:

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sta

ble

up t

o 4

days

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for

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ger

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e C

reat

inin

e in

m

mol

/LC

alcu

late

UPC

R

3.

U

rine

Prot

ein

(mg/

L)

= --

----

----

----

----

----

----

---

U

rine

Cre

atin

ine

(mm

ol/L

)=

__m

g/m

mol

(n

o de

cim

al p

oint

)

Urin

e Pr

otei

ng/

L m

ulti

ply

wit

h 10

00

•➔

mg/

L

Urin

e C

reat

inin

e m

g/dl

m

ultip

ly w

ith 0

.088

4 •

➔

mm

ol/L

µ•

mol

/L d

ivid

e by

100

0➔

mm

ol/L

Inte

rpre

tatio

n of

Urin

e •

Prot

ein

to C

reat

inin

e R

atio

(R

EFER

TA

BLE

2)

Act

ivity

/con

ditio

n th

at m

ay

•in

crea

se u

rinar

y pr

otei

n

over

bas

elin

e va

lues

Con

gest

ive

hear

t fa

ilure

•Ex

erci

se•

Feve

r•

Hae

mat

uria

•In

fect

ion

•M

arke

d hy

perg

lyca

emia

•Po

stur

al p

rote

inur

ia

•Pr

egna

ncy

•S

ev

ere

/ma

lig

na

nt

•hy

perte

nsio

nU

rinar

y tra

ct i

nfec

tion

•

JD005805 Teks 2.indd 14 10/30/12 2:35:33 PM


PKK

/GPe

GFR

/201

2/01

STA

ND

AR

DIZ

ATIO

N O

F C

REA

TIN

INE

ASS

AY, e

GFR

REP

OR

TIN

G A

ND

LA

BOR

ATO

RY

INV

ESTI

GAT

ION

S O

F C

HR

ON

IC K

IDN

EY D

ISEA

SE IN

AD

ULT

S

4.4

24

- Hr U

RIN

E PR

OTE

IN

TEST

/C

LIN

ICA

L SI

GN

IFIC

AN

CE

SPEC

IMEN

CO

LLEC

TIO

N&

PREA

NA

LYTI

CA

L R

EQU

IREM

ENTS

REC

OM

MEN

DED

MET

HO

DC

ALC

ULA

TIO

N&

U

NIT

CO

MM

ENT

24- H

r UR

INE

PRO

TEIN

A ‘g

old

stan

dard

’ for

the

quan

tifica

tion

of

prot

einu

ria

Inst

ruct

ions

fo

r 24

-Hr

urin

e co

llect

ion

Day

1:

Inst

ruct

pat

ient

to

void

at

8 a

m a

nd d

isca

rd t

he s

ampl

e.

Col

lect

all

urin

e in

a 2

4-H

r urin

e co

ntai

ner f

or th

e ne

xt 2

4-H

rs.

Day

2:

Incl

ude

the

final

sam

ple

void

ed

at

8am

in

to

the

urin

e co

ntai

ner.

Kee

p sa

mpl

e in

the

ref

riger

ator

or

in

a co

ol p

lace

dur

ing

the

colle

ctio

n pe

riod.

Labe

l the

con

tain

er w

ith

Two

iden

tifier

s (N

ame

and

•N

RIC

/MR

N)

Dat

e an

d ti

me

coll

ecti

on

•st

arte

dD

ate

and

tim

e co

llec

tion

•

com

plet

ed

Met

hods

incl

ude

:

Dye

bin

ding

(col

orim

etric

) •

(e.g

. Pyr

ogal

lol R

ed)

Turb

idim

etric

(e.g

. •

Ben

zeth

oniu

m C

l)

Cur

rent

ly,

ther

e is

no

refe

renc

e m

easu

rem

ent

proc

edur

e an

d no

st

anda

rdiz

ed

refe

renc

e m

ater

ial

for u

rinar

y to

tal p

rote

in.

24-H

r Urin

e Pr

otei

n is

exp

ress

ed in

g/

24H

r

To c

alcu

late

, fol

low

thes

e st

eps :

Mea

sure

24-

Hr u

rine

vol

ume

in

1.

L/24

Hr

Mea

sure

the

urin

e pr

otei

n in

mg/

L2.

C

alcu

late

24

Hr U

rine

Prot

ein

3.

= U

rine V

olum

e x U

rine P

rotei

n

(L

/24

Hr)

(m

g/L)

= __

_ m

g/24

Hr

= __

__ g/

24 H

r (2 d

ecim

al Po

ints)

10

00

Urin

e Pr

otei

ng/

L m

ultip

ly w

ith 1

000

•➔

mg/

L

24-H

r ur

ine

colle

ctio

ns m

ay

•be

ass

ocia

ted

with

sig

nific

ant

colle

ctio

n er

rors

, la

rgel

y du

e to

im

prop

er t

imin

g an

d m

isse

d sa

mpl

es,

lead

ing

to

over

-col

lect

ion

and

unde

r-co

llect

ion.

Nor

mal

urin

e ou

tput

for

an

•ad

ult

is 0

.5

to 1

.0 m

l/kg/

Hr.

Und

er

colle

ctio

n of

24

H

r ur

ine

volu

me

may

giv

e fa

lsel

y lo

w

conc

entra

tion

of

urin

e pr

otei

n .

Inte

rpre

tatio

n of

24-

Hr

Urin

e •

Prot

ein

(REF

ER T

AB

LE 2

)

JD005805 Teks 2.indd 15 10/30/12 2:35:33 PM


PKK

/GPe

GFR

/201

2/01

STA

ND

AR

DIZ

ATIO

N O

F C

REA

TIN

INE

ASS

AY, e

GFR

REP

OR

TIN

G A

ND

LA

BOR

ATO

RY

INV

ESTI

GAT

ION

S O

F C

HR

ON

IC K

IDN

EY D

ISEA

SE IN

AD

ULT

S

4.5

C

REA

TIN

INE

CLE

AR

AN

CE

(CrC

l)

TE

ST/

CL

INIC

AL

SIG

NIF

ICA

NC

E

SPE

CIM

EN

CO

LL

EC

TIO

N&

PRE

AN

ALY

TIC

AL

RE

QU

IRE

ME

NT

S

RE

CO

MM

EN

DE

D

ME

TH

OD

CA

LC

UL

ATIO

N&

U

NIT

CO

MM

EN

T

CR

EAT

ININ

E C

LE

AR

AN

CE

(CrC

l)

The

crea

tinin

e cl

eara

nce

is a

w

idel

y us

ed

test

to

estim

ate

the

glom

erul

ar

filtra

tion

rate

(G

FR).

Cre

atin

ine

clea

ranc

e is

us

eful

whe

re

MD

RD

equ

atio

n ca

nnot

be

used

.

Sam

ple

need

ed:

Seru

m/p

lasm

a C

reat

inin

e •

shal

l be

tak

en w

ithin

24-

Hr

of

urin

e co

llect

ion

24-H

r U

rine

col

lect

ion

for

•C

reat

inin

e m

easu

rem

ent

Inst

ruct

ions

for

24-

Hr

urin

e co

llect

ion

Patie

nt P

repa

ratio

n:

Avo

id

taki

ng

inte

rfer

ing

med

icat

ions

(REF

ER T

AB

LE 1

). If

pos

sibl

e, d

rugs

sho

uld

be

stop

ped

befo

reha

nd.

Ens

ure

patie

nt d

rink

suf

fici

ent

wat

er

befo

re st

art c

olle

ctin

g and

cont

inue

go

od h

ydra

tion

thro

ugho

ut t

he

proc

edur

e. A

mea

t fr

ee d

iet

is

reco

mm

ende

d

Seru

m c

reat

inin

eM

etho

ds

incl

ude:

Enzy

mat

ic m

etho

d th

at

has

•ca

libra

tion

trac

eabl

e to

an

IDM

S re

fere

nce

mea

sure

men

t pr

oced

ure

Kin

etic

Jaf

fe m

etho

d th

at

•ha

s cal

ibra

tion

trace

able

to a

n ID

MS

refe

renc

e m

easu

rem

ent

proc

edur

e

Urin

e C

reat

inin

eM

etho

ds

incl

ude:

Enzy

mat

ic m

etho

d

•K

inet

ic J

affe

met

hod

•

Cre

atin

ine

clea

ranc

e is

exp

ress

ed i

n m

l/min

To c

alcu

late

, fo

llow

the

se s

teps

:M

easu

re 2

4-H

r ur

ine

volu

me

in

1. L/

24H

rM

easu

re

urin

e cr

eatin

ine

in

2. m

mol

/LM

easu

re

seru

m c

reat

inin

e in

3.

µmol

/LC

alcu

late

cre

atin

ine

clea

ranc

e in

4.

ml/m

in

Urin

e C

reat

inin

e x

24-h

r U

rine

Volu

me

(m

mol

/L)

(L/2

4Hr)

=

----

----

----

----

----

----

----

----

----

Se

rum

Cre

atin

ine

(µm

ol/L

)

= __

x 1,

000,

000

ml/m

in (n

o de

cimal

poin

t)

14

40

24-H

r ur

ine

coll

ecti

ons

may

be

ass

ocia

ted

with

sig

nifi

cant

co

llec

tion

er

rors

, la

rgel

y du

e to

im

prop

er t

imin

g an

d m

isse

d sa

mpl

es,

lead

ing

to

over

-col

lect

ions

and

und

er-

colle

ctio

ns.

JD005805 Teks 2.indd 16 10/30/12 2:35:33 PM


PKK

/GPe

GFR

/201

2/01

TE

ST/

CL

INIC

AL

SIG

NIF

ICA

NC

E

SPE

CIM

EN

CO

LL

EC

TIO

N&

PRE

AN

ALY

TIC

AL

RE

QU

IRE

ME

NT

S

RE

CO

MM

EN

DE

D

ME

TH

OD

CA

LC

UL

ATIO

N&

U

NIT

CO

MM

EN

T

Day

1:

Inst

ruct

the

pat

ient

to

void

at

8 am

and

dis

card

the

sa

mpl

e. C

olle

ct a

ll ur

ine

in a

24

-Hr

urin

e co

ntai

ner

for

the

next

24-

Hrs

.

Day

2: I

nclu

de th

e fin

al s

ampl

e vo

ided

at

8am

int

o th

e ur

ine

cont

aine

r.

Kee

p sa

mpl

e in

the

refr

iger

ator

or

in

a co

ol p

lace

dur

ing

the

colle

ctio

n pe

riod.

Labe

l th

e co

ntai

ner

with

Two

iden

tifie

rs (

Nam

e an

d •

NR

IC/M

RN

)D

ate

and

tim

e co

llec

tion

•

star

ted

Dat

e an

d ti

me

coll

ecti

on

•co

mpl

eted

Due

to la

ck o

f cer

tifie

d se

cond

ary

refe

renc

e m

ater

ial

for

urin

e cr

eatin

ine,

cal

ibra

tion

of ro

utin

e m

etho

ds o

f ur

ine

mea

sure

men

t is

ofte

n pe

rfor

med

with

ser

um

base

d re

fere

nce

mat

eria

l.

Or

To c

alcu

late

, fo

llow

the

se s

teps

:M

easu

re 2

4-H

r ur

ine

volu

me

in

1. m

l/24H

rM

easu

re

urin

e cr

eati

nine

in

2. µm

ol/L

Mea

sure

se

rum

cre

atin

ine

in

3. µm

ol/L

Cal

cula

te th

e cr

eatin

ine

clea

ranc

e 4.

in m

l/min

Urin

e C

reat

inin

e x

24-h

r U

rineV

olum

e

(µm

ol/L

) (m

l/24H

r)=

---

----

----

----

----

----

----

----

----

-

Ser

um C

reat

inin

e (

µmol

/L)

= __

____

__ m

l

14

00 m

in

= __

____

__m

l/min

(no

dec

imal

poi

nt)

JD005805 Teks 2.indd 17 10/30/12 3:08:45 PM


PKK

/GPe

GFR

/201

2/01

STA

ND

AR

DIZ

ATIO

N O

F C

REA

TIN

INE

ASS

AY, e

GFR

REP

OR

TIN

G A

ND

LA

BOR

ATO

RY

INV

ESTI

GAT

ION

S O

F C

HR

ON

IC K

IDN

EY D

ISEA

SE IN

AD

ULT

S4.

6

ESTI

MAT

ED G

LOM

ERU

LAR

FIL

TRAT

ION

RAT

E (e

GFR

) by

M

OD

IFIC

ATIO

N O

F D

IET

IN R

ENA

L D

ISEA

SE (M

DR

D)

TE

ST/

CL

INIC

AL

SIG

NIF

ICA

NC

E

SPE

CIM

EN

CO

LL

EC

TIO

N&

PRE

AN

ALY

TIC

AL

RE

QU

IRE

ME

NT

S

RE

CO

MM

EN

DE

D

ME

TH

OD

CA

LC

UL

ATIO

N&

U

NIT

CO

MM

EN

T

EST

IMAT

ED

G

LO

ME

RU

LA

R

FILT

RAT

ION

R

ATE

(eG

FR)

by MO

DIF

ICAT

ION

O

F D

IET

IN

RE

NA

LD

ISE

ASE

(M

DR

D)

Sam

ple

need

ed:

Seru

m/p

lasm

a C

reat

inin

e • R

equi

rem

ent b

efor

e ap

plic

atio

n o

f M

DR

D e

quat

ion

Plea

se e

nsur

e th

e re

quir

emen

ts

belo

w a

re f

ulfil

led

Met

hod

for

seru

m/p

lasm

a •

crea

tinin

e m

easu

rem

ent

mus

t be

trac

eabl

e to

IDM

S re

fere

nce

mea

sure

men

t pr

oced

ure.

Uni

t m

easu

rem

ent

of

seru

m/

•pl

asm

a cr

eati

nine

is

in

µm

ol/L

Seru

m/P

lasm

a C

reat

inin

e*

mg/

dl m

ultip

ly w

ith 8

8.4 ➔

µm

ol/L

Met

hods

for

ser

um/p

lasm

a cr

eatin

ine

in

clud

e:

Enzy

mat

ic m

etho

d t

hat

•ha

s ca

libra

tion

trac

eabl

e to

an

IDM

S re

fere

nce

mea

sure

men

t pr

oced

ure

Kin

etic

Jaf

fe m

etho

d th

at

•ha

s ca

libra

tion

trac

eabl

e to

an

IDM

S re

fere

nce

mea

sure

men

t pr

oced

ure.

MD

RD

eG

FR v

alue

is

expr

esse

d in

m

l/min

/1.7

3m2

(no

deci

mal

poi

nt)

To c

alcu

late

, fo

llow

the

se s

teps

:

Mea

sure

se

rum

cr

eatin

ine

in

1. µm

ol/L

Age

is

expr

esse

d in

yea

rs.

2. C

alcu

late

MD

RD

eG

FR i

n 3.

ml/m

in/1

.73m

2

= 17

5 x

(Scr

/88.

4)-1

.154

x (

Age

)-0.2

03

x (0

.742

if

fem

ale)

(no

dec

imal

po

int)

The

equa

tion

does

not

requ

ire w

eigh

t m

easu

rem

ent

beca

use

the

resu

lts a

re

repo

rted

norm

aliz

ed to

1.7

3 m

2 bod

y su

rfac

e ar

ea,

whi

ch i

s an

acc

epte

d av

erag

e ad

ult

surf

ace

area

.

The

abov

e eq

uatio

n is

not

app

licab

le

for A

fric

an B

lack

. H

owev

er, t

he re

sult

can

be g

ener

ated

by

mul

tiply

ing

the

eGFR

res

ult

deriv

ed f

rom

the

abo

ve

equa

tion

with

1.2

12

Inte

rpre

tatio

n of

MD

RD

eG

FR

•va

lue

(R

EFER

TA

BLE

3)

LIM

ITAT

ION

S O

F TH

E M

DR

D

eGFR

The

MD

RD

equ

atio

n sh

ould

not

be

used

in s

ome

popu

latio

ns w

here

it

has n

ot b

een

spec

ifica

lly v

alid

ated

, in

clud

ing:

Paed

iatri

c pa

tient

s (<

18 y

ears

)•

Elde

rly p

atie

nts

(>70

yea

rs)

•D

ialy

sed

patie

nts

•Pr

egna

nt m

othe

rs•

Ext

rem

es

of

body

ha

bitu

s •

ie m

alnu

trit

ion,

par

aple

gia,

qu

adrip

legi

aPa

tien

ts w

ith

skel

etal

mus

cle

•di

sord

ers

Vege

taria

ns

•Pa

tien

ts

wit

h ve

ry

rapi

dly

•ch

angi

ng k

idne

y fu

nctio

n Pa

tient

s on

rena

lly e

xcre

ted

drug

s •

that

hav

e si

gnifi

cant

tox

icity

Seve

re d

ehyd

ratio

n •

Pati

ents

on

med

icat

ions

tha

t •

mig

ht in

terf

ere

with

the

crea

tinin

e m

easu

rem

ent

Not

sui

tabl

e fo

r dr

ugs

dosi

ng•

Inco

mpl

ete

esse

ntia

l inf

orm

atio

n •

(age

, ge

nder

, ra

ce)

JD005805 Teks 2.indd 18 10/30/12 2:35:33 PM

STA

ND

AR

DIZ

ATIO

N O

F C

REA

TIN

INE

ASS

AY, e

GFR

REP

OR

TIN

G A

ND

LA

BOR

ATO

RY

INV

ESTI

GAT

ION

S O

F C

HR

ON

IC K

IDN

EY D

ISEA

SE IN

AD

ULT

S4.

6

ESTI

MAT

ED G

LOM

ERU

LAR

FIL

TRAT

ION

RAT

E (e

GFR

) by

M

OD

IFIC

ATIO

N O

F D

IET

IN R

ENA

L D

ISEA

SE (M

DR

D)

TE

ST/

CL

INIC

AL

SIG

NIF

ICA

NC

E

SPE

CIM

EN

CO

LL

EC

TIO

N&

PRE

AN

ALY

TIC

AL

RE

QU

IRE

ME

NT

S

RE

CO

MM

EN

DE

D

ME

TH

OD

CA

LC

UL

ATIO

N&

U

NIT

CO

MM

EN

T

EST

IMAT

ED

G

LO

ME

RU

LA

R

FILT

RAT

ION

R

ATE

(eG

FR)

by MO

DIF

ICAT

ION

O

F D

IET

IN

RE

NA

LD

ISE

ASE

(M

DR

D)

Sam

ple

need

ed:

Seru

m/p

lasm

a C

reat

inin

e • R

equi

rem

ent b

efor

e ap

plic

atio

n o

f M

DR

D e

quat

ion

Plea

se e

nsur

e th

e re

quir

emen

ts

belo

w a

re f

ulfil

led

Met

hod

for

seru

m/p

lasm

a •

crea

tinin

e m

easu

rem

ent

mus

t be

trac

eabl

e to

IDM

S re

fere

nce

mea

sure

men

t pr

oced

ure.

Uni

t m

easu

rem

ent

of

seru

m/

•pl

asm

a cr

eati

nine

is

in

µm

ol/L

Seru

m/P

lasm

a C

reat

inin

e*

mg/

dl m

ultip

ly w

ith 8

8.4 ➔

µm

ol/L

Met

hods

for

ser

um/p

lasm

a cr

eatin

ine

in

clud

e:

Enzy

mat

ic m

etho

d t

hat

•ha

s ca

libra

tion

trac

eabl

e to

an

IDM

S re

fere

nce

mea

sure

men

t pr

oced

ure

Kin

etic

Jaf

fe m

etho

d th

at

•ha

s ca

libra

tion

trac

eabl

e to

an

IDM

S re

fere

nce

mea

sure

men

t pr

oced

ure.

MD

RD

eG

FR v

alue

is

expr

esse

d in

m

l/min

/1.7

3m2

(no

deci

mal

poi

nt)

To c

alcu

late

, fo

llow

the

se s

teps

:

Mea

sure

se

rum

cr

eatin

ine

in

1. µm

ol/L

Age

is

expr

esse

d in

yea

rs.

2. C

alcu

late

MD

RD

eG

FR i

n 3.

ml/m

in/1

.73m

2

= 17

5 x

(Scr

/88.

4)-1

.154

x (

Age

)-0.2

03

x (0

.742

if

fem

ale)

(no

dec

imal

po

int)

The

equa

tion

does

not

requ

ire w

eigh

t m

easu

rem

ent

beca

use

the

resu

lts a

re

repo

rted

norm

aliz

ed to

1.7

3 m

2 bod

y su

rfac

e ar

ea,

whi

ch i

s an

acc

epte

d av

erag

e ad

ult

surf

ace

area

.

The

abov

e eq

uatio

n is

not

app

licab

le

for A

fric

an B

lack

. H

owev

er, t

he re

sult

can

be g

ener

ated

by

mul

tiply

ing

the

eGFR

res

ult

deriv

ed f

rom

the

abo

ve

equa

tion

with

1.2

12

Inte

rpre

tatio

n of

MD

RD

eG

FR

•va

lue

(R

EFER

TA

BLE

3)

LIM

ITAT

ION

S O

F TH

E M

DR

D

eGFR

The

MD

RD

equ

atio

n sh

ould

not

be

used

in s

ome

popu

latio

ns w

here

it

has n

ot b

een

spec

ifica

lly v

alid

ated

, in

clud

ing:

Paed

iatri

c pa

tient

s (<

18 y

ears

)•

Elde

rly p

atie

nts

(>70

yea

rs)

•D

ialy

sed

patie

nts

•Pr

egna

nt m

othe

rs•

Ext

rem

es

of

body

ha

bitu

s •

ie m

alnu

trit

ion,

par

aple

gia,

qu

adrip

legi

aPa

tien

ts w

ith

skel

etal

mus

cle

•di

sord

ers

Vege

taria

ns

•Pa

tien

ts

wit

h ve

ry

rapi

dly

•ch

angi

ng k

idne

y fu

nctio

n Pa

tient

s on

rena

lly e

xcre

ted

drug

s •

that

hav

e si

gnifi

cant

tox

icity

Seve

re d

ehyd

ratio

n •

Pati

ents

on

med

icat

ions

tha

t •

mig

ht in

terf

ere

with

the

crea

tinin

e m

easu

rem

ent

Not

sui

tabl

e fo

r dr

ugs

dosi

ng•

Inco

mpl

ete

esse

ntia

l inf

orm

atio

n •

(age

, ge

nder

, ra

ce)

APPENDIX

JD005805 Teks 2.indd 19 10/30/12 2:35:33 PM

JD005805 Teks 2.indd 20 10/30/12 2:35:33 PM


GARIS PANDUAN UNTUK MEMOHON DAN MELAPOR eGFR

1. Borang permohonan 1.1 Gunakan borang PER. PAT 301 1.2 Maklumat lain • Maklumat sejarah penyakit yang berkaitan • Keputusan ujian creatinine lampau, jika ada • Keputusan Creatinine Clearance lampau, jika ada • Pengiraan ujian eGFR lampau, jika ada

2. Keputusan serum/plasma creatinine yang sampelnya dihantar bersama-sama borang PER. PAT 301 sahaja akan dibuat pengiraan eGFR.

3. Keputusan creatinine yang lampau (previous results) tidak akan digunakan bagi pengiraan eGFR. Ini kerana keputusan ujian lampau eGFR boleh menimbulkan masalah dari segi intepretasi keputusan ujian mengikut keadaan semasa pesakit.

4. Pengiraan eGFR secara manual 4.1 eGFR boleh dikira menggunakan CKD and eGFR Laboratory Tools

(CELT) software. 4.2 Semakan transkripsi perlu dilakukan.

5. Pengiraan eGFR secara automatik 5.1 Gunakan formula eGFR yang disarankan dan format laporan yang

disediakan. Formula dan format laporan perlu disahkan oleh Pakar Patologi Kimia atau pegawai yang bertanggungjawab sebelum memulakan penggunaannya buat pertama kali.

6. Format Laporan eGFR 6.1 Formula pengiraan eGFR menggunakan MDRD eGFR dalam ml/

min/1.73m2 175 x (Scr /88.4)-1.154 x (Age)-0.203 x (0.742 if female)

The equation does not require weight measurement because the results are reported normalized to 1.73 m2 body surface area, which is an accepted average adult surface area.

This equation is not applicable for African Black.

6.2 Kenyataan di bawah (Disclaimer) akan dikeluarkan bersama laporan eGFR (eGFR report)

LIMITATIONS OF THE MDRD eGFR The MDRD equation should not be used in some populations where it

has not been specifically validated, including: • Paediatric patients (<18 years) • Elderly patients (>70 years)

APPENDIX I

JD005805 Teks 2.indd 21 10/30/12 2:35:33 PM


GARIS PANDUAN UNTUK MEMOHON DAN MELAPOR eGFR

• Dialysed patients • Pregnant mothers • Extremes of body habi tus ie malnutr i t ion, paraplegia,

quadriplegia • Patients with skeletal muscle disorders • Vegetarians • Patients with very rapidly changing kidney function • Patients on renally excreted drugs that have significant toxicity • Severe dehydration • Patients on medications that might interfere with the creatinine

measurement • Not suitable for drugs dosing • Incomplete essential information (age, gender, race)

APPENDIX I

JD005805 Teks 2.indd 22 10/30/12 2:35:33 PM

APPENDIX I eGFR REPORTING FORMAT APPENDIX II

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ME�

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RD

/ C

LIN

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AT

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EQ

UE

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RE

CE

IVE

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AM

E O

F D

OC

TO

R�

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BA

RC

OD

E N

O

��

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R R

EP

OR

T

�C

RE

AT

ININ

E R

ES

UL

T�

��

�m

ol/

l�

eG

FR

VA

LU

E�

��

ml/

min

/1.7

3 m

�*�

CR

EA

TIN

INE

AS

SA

Y M

ET

HO

D�

Jaff

e K

ineti

c /

En

zy

mati

c�

�M

OD

IFIC

AT

ION

OF

DIE

T I

N R

EN

AL

DIS

EA

SE

(M

DR

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EQ

UA

TIO

N

�

17

5 x

(S

cr/

88

.4)-1

.154 x

(A

ge)-0

.203 x

(0

.74

2 if

fe

male

)

�

Th

e e

qu

ati

on

do

es

no

t re

qu

ire w

eig

ht

measu

rem

en

t b

ecau

se t

he r

esu

lts

are

rep

ort

ed

no

rmali

zed

to

1.7

3 m

2 b

od

y s

urf

ace

are

a, w

hic

h i

s an

accep

ted

av

era

ge a

du

lt s

urf

ace a

rea.

* T

his

eq

uati

on

is

no

t ap

pli

cab

le f

or

Afr

ican

B

lack

ST

AG

ES

OF

CK

D�

GF

R (

ml/

min

/1.7

3m

2)�

Desc

rip

tio

n

1�

>9

0�

No

rmal

or

incre

ase

d G

FR

, w

ith

oth

er

ev

iden

ce o

f k

idn

ey d

am

age�

2�

60

-89

Sli

gh

t d

ecre

ase

in

GF

R,

wit

h o

ther

ev

iden

ce o

f k

idn

ey

dam

ag

e�

3A�

45

-59

3B

30

-44

Mo

dera

te d

ecre

ase

in

GF

R, w

ith

or

wit

ho

ut

oth

er

ev

iden

ce o

f k

idney

dam

age�

4�

15

-29

Sev

ere

decre

ase

in

GF

R,w

ith

or

wit

ho

ut

oth

er

ev

iden

ce o

f k

idney

dam

age�

5�

<1

5�

Est

ab

lish

ed

ren

al

fail

ure�

��

�

LIM

ITA

TIO

NS

OF

TH

E M

DR

DeG

FR�

��

Th

e M

DR

D e

qu

ati

on

sh

ou

ld n

ot

be u

sed

in

so

me p

opu

lati

on

s w

here

it

has

no

t b

een

sp

ecif

icall

y v

ali

date

d, in

clu

din

g�

Paed

iatr

ic p

ati

en

ts (

<1

8 y

ears

)��

Veg

eta

rian

s�

Eld

erl

y p

ati

ents

(>

70

years

)��

Pati

en

ts w

ith

very

rap

idly

ch

ang

ing

kid

ney

fu

ncti

on�

Dia

lyse

d p

ati

en

ts�

�P

ati

en

ts o

n r

en

all

y e

xcre

ted

dru

gs

that

hav

e s

ign

ific

an

t to

xic

ity�

Pre

gn

an

t m

oth

ers�

�S

ev

ere

dehy

dra

tio

n�

Ex

trem

es

of

bo

dy

hab

itu

s ie

maln

utr

itio

n, p

arap

leg

ia, qu

ad

rip

leg

ia�

�P

ati

en

ts o

n m

ed

icati

on

s th

at

mig

ht

inte

rfer

e w

ith

th

e c

reati

nin

e m

easu

rem

ent�

Pati

en

ts w

ith

sk

ele

tal

mu

scle

dis

ord

ers�

�N

ot

suit

ab

le f

or

dru

gs

do

sing�

��

�

� CO

MM

EN

T:

R

EP

OR

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D B

Y:�

VA

LID

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ED

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:

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:�

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JD005805 Teks 2.indd 23 10/30/12 2:35:34 PM


FACTORS THAT MAY AFFECT CREATININE GENERATION

TAB

LE

1:

F

AC

TOR

S T

HAT

MAY

AFF

EC

T C

RE

ATIN

INE

GE

NE

RAT

ION

Mec

hani

sms

Fact

ors

Red

uced

cre

atin

ine

gene

ratio

n-

Dec

reas

e se

rum

/ p

lasm

a cr

eatin

ine

Old

er A

ge•

Fem

ale

Sex

•M

alnu

tritio

n•

Mus

cle

was

ting

•A

mpu

tatio

n•

Incr

ease

d cr

eatin

ine

gene

ratio

n-

Incr

ease

ser

um /

pla

sma

crea

tinin

eA

fric

an B

lack

•In

crea

sed

mus

cle

mas

s•

Inge

stio

n of

coo

ked

mea

ts (

Tran

sien

t in

crea

se)

•

Dec

reas

ed

crea

tinin

e cl

eara

nce

by

inhi

bitin

g t

ubul

ar s

ecre

tion

of c

reat

inin

e

M

edic

atio

ns t

hat

may

inc

reas

e se

rum

/pla

sma

crea

tinin

e i

nclu

de:

Cep

halo

spor

in a

nd a

min

ogly

cosi

de a

ntib

iotic

s•

Fluc

ytos

ine

•C

ispl

atin

•C

imet

idin

e•

Trim

etho

prim

•

APPENDIX III

JD005805 Teks 2.indd 24 10/30/12 2:35:34 PM


DIAGNOSIS OF ABNORMAL PROTEIN OR ALBUMIN EXCRETION

APPENDIX III

TAB

LE

2:

DIA

GN

OSI

S O

F A

BN

OR

MA

L PR

OT

EIN

OR

AL

BU

MIN

EX

CR

ET

ION

CL

ASS

UA

CR

(mg/

mm

ol)

UPC

R(m

g/m

mol

)U

RIN

E 2

4 H

R P

RO

TE

IN(g

/24

Hr)

Nor

mal

<2.5

(m

ale)

<3.5

(fe

mal

e)<1

5<0

.15

Trac

e pr

otei

n (M

icro

albu

min

uria

)≥

2.5

to 3

0 (m

ale)

≥3.5

to

30 (

fem

ale)

15-4

40.

15 –

0.4

4

Ove

rt P

rote

inur

ia(M

acro

albu

min

uria

)>3

0>

45>

0.45

* M

odif

ied

from

Sco

ttis

h In

terc

olle

giat

e G

uide

line

s N

etw

ork.

Dia

gnos

is a

nd m

anag

emen

t of

chr

onic

kid

ney

dise

ase.

E

dinb

urgh

: SI

GN

; 20

08

APPENDIX IV

JD005805 Teks 2.indd 25 10/30/12 2:35:34 PM


STAGING OF CHRONIC KIDNEY DISEASE

TAB

LE

3:

STA

GIN

G O

F C

HR

ON

IC K

IDN

EY

DIS

EA

SE

STA

GE

S O

F C

KD

Stag

eG

FR (

ml/m

in/1

.73m

2 )D

escr

iptio

n

1>9

0N

orm

al o

r in

crea

sed

GFR

, w

ith o

ther

ev

iden

ce o

f ki

dney

dam

age

260

-89

Slig

ht d

ecre

ase

in G

FR,

with

oth

er e

vide

nce

of k

idne

y da

mag

e

3A45

-59

Mod

erat

e de

crea

se i

n G

FR,

with

or

with

out

othe

r ev

iden

ce o

f ki

dney

dam

age

3B30

-44

415

-29

Seve

re d

ecre

ase

in G

FR,

with

or

with

out

othe

r ev

iden

ce o

f ki

dney

dam

age

5<1

5Es

tabl

ishe

d re

nal

failu

re

APPENDIX V

JD005805 Teks 2.indd 26 10/30/12 2:35:34 PM


APPENDIX V

WORKING GROUP FOR THE STANDARDISATION OF eGFR IN CKD (ADULTS)

Chairman

Dr. Muhammad Arif Mohd. HashimSenior Consultant Pathologist andHead of Pathology DepartmentHospital Kuala Lumpur e-mail : [email protected]

Members

Dr. Baizurah Mohd. HussainSenior Consultant Pathologist andHead of Pathology DepartmentHospital Ampang e-mail : [email protected]

Dr. Siti Sharina AnasChemical PathologistHospital Putrajaya e-mail : [email protected]

Dr. Hanisah Abdul HamidChemical PathologistHospital Tengku Ampuan Rahimah, Klang e-mail : [email protected]

Dr. Nik Ahmad Zahar Nik YahChemical PathologistHospital Raja Permaisuri Bainun, Ipoh e-mail : [email protected]

En. Liew Chuan HeeScientific Officer (Biochemist)Hospital Tengku Ampuan Rahimah, Klang e-mail : [email protected]

En. Abdul Rahim bin OsmanScientific Officer (Biochemist)Hospital Kuala Lumpur e-mail : [email protected]

Cik Kanchana KanthasamyScientific Officer (Biochemist)Hospital Kuala Lumpur e-mail : [email protected]

Cik Lili Tresa ArulananbanMedical Laboratory TechnologistKlinik Kesihatan Tanglin e-mail : [email protected]

En. Lee Lian HoeMedical laboratory TechnologistHospital Selayang e-mail :[email protected]

JD005805 Teks 2.indd 27 10/30/12 2:35:34 PM


REFERENCES

1. Ministry Of Health. Management of Chronic Kidney Disease in Adults. MOH/P/PAK/217.11(GU) ; 2011

2. W. Greg Miller, David E. Bruns et al. Current Issues in Measurement and Reporting of Urinary Albumin Excretion Clinical Chemistry 2009 ; 55(1):24–38

3. Robert M. Breslow. Evaluating Kidney Function: Impact on Clinical Decision Making for the Pharmacist Caring for the Older Adult JPSW 2011 ; 44-54

4. National Kidney Foundation : Frequently Asked Questions About GFR Estimates 2010

5. Jinn-Yuh Guh. Proteinuria versus Albuminuria in Chronic Kidney Disease. Journal Compilation Asian Pacific Society of Nephrology 2010 ; 15 : 53–56

6. Edmund J. Finlay M. et al. How should proteinuria be detected and measured? Ann Clin Biochem 2009 ; 46 : 205 – 217

7. Graham RD Jones. Laboratory reporting of Urine Protein and Albumin. Clin Biochem Rev 2011 ; 32(2) : 103-107

JD005805 Teks 2.indd 28 10/30/12 2:35:34 PM


ACKNOWLEDGEMENTS

The Editorial Committee wishes to thank the following for their invaluable support, guidance and direction in the preparation of this guideline, without whose provision of relevant information the production of this guidelines book would not have been possible:

Director General of Ministry of Health•

National Chemical Pathology Services•

National Nephrology Services•

Family Health Development Division•

National Public Health Laboratory•

Special thanks are also accorded to individuals who have directly or may indirectly involved in the compilation and publication of this guidelines.

JD005805 Teks 2.indd 29 10/30/12 2:35:34 PM

PRINTED BYPERCETAKAN NASIONAL MALAYSIA BERHADKUALA LUMPUR, 2012www.printnasional.com.myemail: [email protected].: 03-92366895 Fax: 03-92224773

JD005805 Teks 2.indd 30 10/30/12 2:35:34 PM

Chemical Pathology DisciplineNational Pathology ServicesMinistry of Health Malaysia

Laboratory InvestIgatIon guIdeLInesFor

CHronIC KIdney dIsease and utILIsatIon oF egFr In aduLts

MiNiStry of HealtH MalaySia

OCTOBER 2012

JD005805_KULIT INVESTIGATOR ndd.indd 1 10/30/12 1:59:29 PM

laboratory investigation guidelines for chronic kidney ... guideline.pdf · chemical pathology...

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