Crba
Webs le : www.erbamannheim com
CHOLESTEROL DES
DYNAMIC EXTENDED STABILITY ((
CHOD.PAP METHOD (Wth LCF), END POINT @
INIENDEDUSE REAGENT RECOT{STITUTION
Diagnostc reagent lorquani tative,, v,lro determinalon or Allow R€ag€nl I End Aqua 4 to at€in mom l€mperature (1 5-30'C).
Cholestercl in human serum and pasma. Add lhe amounl of Aqua-4 indicalsd on the lab€lto conlents of
each nal of R€agent'1. Swid lodissol\€. Do nol shake vigomusly.
CLINlcAT SIGNIFICANCE
Measuremsnt of serum choleslerol lewls can sen€ as an
STORAGE AND STABILITY
indicalor of lilEr lunciion, biliary funct on, inlestinal absorptior,
Prior to reconstitution
Unopened rcag€nt and slandard arc slabl€ till ihe eeary dale
prc pensily towards comnary artery disease, thyroid tunction
siated on lhe lab€lwhen slorcd at2-8'C.
and adrcnal disease. Choleslerol lewls are imponani in ihe
aKeep
diagnosis and classilrcal,ol ol hyper rpoproteinaen ias. the Standa.d vial plugged afrer us6, in order to
Stress, age, gender, hormonal balance and pregnancy affect arcid deteiioration.
normal chol€siercl leEls.
Aner reconstitution
'fte wo*ing Chol€sterc'l reagent is slabl€ ior 365 days at2-8'C.
METHODOLOGY
Discard reagent ir it lums iurbid or if its abso.banc€ is grsater ihan
Modfi ed Roeschlau's M€thod
0.4 at 505nm aqainst dislilled water.
PRINCIPLE
SPECIMET{ COLLECTION A}ID HANDUNG
The estimaton ol choteslerct InwlEs the fotbwing enzy.ne
Use serum, plasma (hspann, EDTA).
I is rscommended to follow NCCLS prccedues (or simitar
1. Cholesteml ester j-,
standardized conditions).
Choleslerol + Fany acid
Slablllty
2. chotesterct + o, cHoo> chotestr en,3-one + H,o, in s.rum/ pl.ffil': at 20-25"C Tdays
zl-8.C
at 7 days
3. 2H,o-+ 4AAp + pheno. PoD +tt,o + eu,noneim'ne 6t-20'C
- Oiscard contaminal€d sp€cimens.
3 months
CE
CHOO i
ASSAY P'IRAM ETERS
Absorbance ofOuinoneimine so lormed is dkectly prcpod onal lo
Cholesteml conenlration in lh€ specimen. Wavelenath 1 (nm ) 505
Wavelensth 2 (nrn ) 670
REASENT COMPOSITION (l'then racomrituted as dlrecGd) Sam ple Volu m e (!l 't o t20
REAGENT 'I : CHOLESTEROLREAGENT Reasenl Volum e (ul 500/1000
ln cu balion Tim e (m in. 10
Cholesterol esterase (Pancreaticl > 200 ru/L
ln cu bation Tem o ('C ) 37
Cholesterol oxidase (microbial) > 150 ru/L
Norm al Low (m g/d l) 0
Peroxidase (horseradish) > 2000 tu/L
Norm al Hioh (m o/dl 200
Linearity Low (m s/d I 0
4 - Amifloaniioyrine 0.5 mmol/L
Liaearity H iqh (mo/dl 600
Phosphale bufter {DH 6.5 } 0.1 68 mmol/L
C o n ce niraiio n ot Sla n da rd q/dL 200
1m
L pid Clearinq Aoent
Bankwth
Ab s orbance Lim il (Max.) 0.40 0
CHOLESTEROL STANDARD
standard 200 hs/dl
cholesterol | Programme Framebrsfu rsp€cifc cllnlcal amlysal3srD
available on request
AQUA.4
OoLble dao.rTed 02 r c or renb'ane lllared. OUALTTY COiITROL
rticle - free wate. for reconstitution otReaaenl 1 Forquality controlERBA NORM and ERBA PATH als rscomm€nd€d.
d Uanuractured by : TRANSASIA BIO-TTEDICALS LTD., Natagarh Road, M age Matpur, Baddi, Dist. Sotan, (Hp) - 173205.
ln Technical Collaboration with : €RBA diagnosti<s Mannh€im GmbH ralau3rr,69-73, D,68219, fannhetm/cermany
ASSAY PROCEDURE INTERFERENCES
Pipette into Following subslances do nol inlerfere:
Blank Slandard unr. oilirubin up to 20 ms/dr, trislyceddes up
F:6"0f';3ii,ro "
1000 !l 1000 pl 1000 !l
Dislilled Water 20 pl PERFORMANCE OATA
Standard 20 ul Dal,a contained wilhin thisseclion is representatile of performance
20 ul on ERBA systems. Data obtained in your laboratory may differ
Mixwell incubale at 37'C for 10 minules. Aspirate Blank followed Linearity: 600 rng/dl
by Standard and Tests. Read the absorbance of standard and
each lesl tube against blank at 505 nm or 505/670 nm on
Measuring range: 0 600 mg/dl
PREOSION
bichromalic ana yzer
lntra-assay precision
So (mg/dl) cv {%)
CALCULATION Sample 1 846 0.9 1.1
Absorbance of Test
Cholesterol = Abso/oance of Standard
x Standard (mg/dl)
Sample 2 140.'1 1.33 0.95
(ms/dl)
lnteFassay pr€cision
(mg/dl)
sD (ms/dl) cv l%)
EXPECTED VALUES
114 A 1.23 '1.O7
Adult
Desirable blood Cholesterol < 200 mg/dl Sample 2 193.3 3.16 1.63
Bordedine high blood Choleslerol 200- 239 mg/dl
High blood Choleslerol > 239 mg/dl
WARNING Al{D PRECAUTIoN'IS
chiH
For in vitro diagnostic use- To be handled by entitled and
Desirable blood Choleslerol < 170 mg/dl
professionally educated person,
Borderline high blood Choleslerol 170 - 199 mg/dl Reagenl of lhe kit is noi classified like dangerous but contains
High blood Cholesterol > 19S mg/dl less lhan 0.1% sodium azide - classified as very loxac and
dangerous subslance for lhe envronment.
It is rcco|ItrEnd.d ihat each laboiaiory verlfy thl3 range
daalv63 aeference interyal for the population it serv8.
WASTE i,!Ar'IAGEII ENT
Pleaso refer to local teoal requirements.
CqtlBARISON
A comparison belwsen ERBA Cholesterol (y) and a REFERENCES
commsrcially svailable t6sl (x) using 40 samples gave 1. Allain C. C., Poon L. S., Chan C.S.c, Richmond W_ and Fu P,
following results: Clin. Cham., 20(470) 1974.
y = 0.995 x- 4.59 mg/dl 2. Roeschlau P, Bsmt E., and Gruter W. A., Clin. Chem- Ctan
r= 1.000 Bio€hem 12(226), 1974.
PACK PRESENTATION
SYIi,BOLS:
The following symbols are ussd in the labelling of Reag6nt I Cholestero
ERAA Mannheim kits:
Code Cholest6rol
Catalogue No af
\\
cE [,lad, - Device comply Reaqenl
wth the Dnedve 98,?9i EC 120194 5 20ml 5 x 20ml
x 1xsml 'I x 100m
120195 l0 x 50m 't0 x 50ml 2r5ml 2 x 300m
Batch Code ln VitrD oiagnostics
B illl'r3;$*"*,r,1 ffi con"'r,'"t'a;onto'u'"
Revision No.: 5- FBCER - CHOL
Date oflssue : 12/ lOl2OlS
It4anuiaclured by ,'o,,n",",*,,r,"
{ lso 9001, tso 134a5
QUATIIYSYSTEM CERTIFIED
f-r*_l ProduaName
lioNil conrenr
