Grbd Ir,l-i@)
W6bsile : www.erbamannheim.com
TRIGLYCERIDES DES
DYNAMIC EXTENDED STABILITY
WITH LIPID CLEARING AGENT ((
GPO . TRINDER METHOD, END POINT E
INTENDEDUSE
TRIGLYCERIDES STANDARD
Oiagnostic rcagent for quanlrtatrve in vilro detemination of Tig
iycerdes h i -,, an serlm and .iasma I Tirsr),,rcrder sta"darc
- l Ze_!ggfltt;."r,ul
CLINICAL SIGNIFICANCE REAGENT RECONSTITUTION
Triglyc€rides are a famrly of lipids absorbed from the diet and Alow the reagent bottle and AQUA-4 (Suppttedinthe kit) to
produced endogenously from carbohydrates t\,leasurement of atlain room temperature (15,30'C) Add rhe amount of
Triglycerides is rmpodant in the d agnos s and management of AQUA-4 indicaled on the label to the contents of each
hyperlipidemias These diseases can be genetc or secondary vralSwrl lo dissove allow to stand for 10 minutes at room
to oiher dlsorders including nephrosis diabetes mettiius and iemperaturc Oo not shake vigorously
eodocnne disturbances. Elevation of Triglycerides has been
idenlified as a risk lactor for atheroscteronc disease STABILITYAND STORAGE
METHODOLOGY The reagents are stable til the expiry date stated
This reagent is based on the metnod of Wako and the 'rnopened
on the bottle and kt label when stored at 2-A.C
modilications by l4ccowan et al and Fossati er at.
PRINCIPLE SPECIMEN COLLECTION ANO HANDLING
Tnglycerides + H,O LPL> Gty".rot + Free fafiy acids Use unheamolylc serum, plasma (EDTA, heparin).
It is recommended to iollow NCCLS procedures (or simitar
Giycerol+ ArP GK > (iycerot-3-phospnare +ADp standardlzed cond{ons)
Mo':
Cly.€rol3 Phosohaie
' O, "':+ DAP * H?O,
Stability
Peroxidase 2 days at2O-25'C
H,o: + 4MP +3 s-DHBS Quinoneiminedye
+ 2H,O 7 days at 4-8'C
LPL Lipoprotein Lipase at least 1 yea. at -20'C
GK Glycerol Kinase Discald contaminated specimens.
GPO Glycerol Phosphate Oxidase
DAP - Drhydro)ryacetone phosphate
ATP,Adenosnetphosphate
4AAP ,4 Aminoannpyrine ASSAY PARAMETERS
DHBS 3s,Dichloro-2hydroxybenzene
End Poinl
The intensity of chromogen (Quinonemne) formed is propotionat 505
to lhe Triglycerides concentralion in the sampte \Nhen measursd at Wa,€lengr| 2 (nm) 670
505nm (500-540 nm) Sample VolLrme (ul) 5/10
ReagentVolume (pl) 500/1000
REAGENT COMPOSTTTON (When r€constitutcd as directod)
REAGENT 1 : IRIGLYCERIDES DES REAGENT I',cuiralion Time (min.) 1U
lncubalion Tempemture ('C) 37
Normal Low (mg/dl) 25
25mmoUL
It!g'' NormalHigh (mg/dl) 160
2 5 m rnol/L
LinearilyLow (mq/dl) 0
0 8 mmouL
3,5 DHBS Linearily High (mg/dl) 1000
> 2000u/L Concentration of Standard (mg/dl) 200
> 550 U/L Blank Wt'r Reagenl
GPO >8000u/L 05
Lipoprotein LiDas e >3500 u/L Units m g/d
Buffer (pH 7 0 r 0 1 at 2 0'C ) 53 mmol/L Programrl|e palamelels Ior specif ic clinical analysers
Aso conlains non-reaclve I ers stab zers and surfaclafls arc available on request,
d Manulactured by : TRANSASIA BIO-IIEDICALS LTD., t,latagarh Road, M Ege Matpur, Baddi, Dist. Sotan, (Hp) - i73205.
ln Technical Collaboralion wilh:
€RBA diagnostics MannhGim GmbH r.[i6r,., o$r3, D -.rfir, x.nnh.tm / c.m y
ASSAY PROCEDURE EXPECTEDVALUES
Recommended Triglycerides levets tor adutts:
Pipetre into tubes marked Blank < 161 rng/dl
1000! 1000!l l0O0!l High: 161 - 199 mg/dl
10 !l Hypertriglyceridemic 200 - 499 mg/dl
10 pl Very high: > 499 mg/dl
1O !l
It is recommended that each taboratory estabtish it's own
Mix and indba!6 for 10 min. at37"C. Read the absorbance of range depending on population it serves.
siandaid aiiJ scch rect ai :ti rir, (500,a40 n,i) ar 5C5€73 iin oi,
bichromatic analysers againsl rcagent btank
PERFORMANCE DATA
CALCULATIONS
Linearlty: 1000 mg/dl
Tnglycer des (ms/ilL) =
Measurlng rang€: 0- 1000 mg/dl
Standard (mg/dl)
Procbion:
LEVEL I LEVEL II
COMPARISON Number of Samples 40 4A
lv'lean (ms/d ) 99 152
A comparison between Triglycerdes (y) a.d a commerciatty S D (mg/dl) 0.5 09
ava able test (x) us ng 40 samples gave fo owing resutts
y = 1422)<- 1.15 mgldl
c.v. (%) 05 06
r=0999
INTERFERENCES
Forlowrng substances oo noi rntenere
haemoglobn up lo 10 94. brrtrubrn uo to 40 mg/d..
QUALITY CONTROL WARNING AND PRECAUTIONS
Forquality control ERBA NORM and ERBA PATH are recommended. For i, vitro diagnostic use Io be handled by entitted afd
Professionaily educated person
Reagent of the kit is nol ctassrted tike dangerous
SYMBOLS:
The following symbols are in rhe labe ng or ERBA
WASTE MANAGEMENT
E c(
Please refer to local legai rcqu rements
E
REFERENCES
E 1 Producl Daia sheel. Triglycende c code no 997 -69801.
8 tril'":i5,".."",,, ttr *^-**,*-* 2
WAKO Pure Chemical lndustries Ltd ,Dallas TX
elal Clin Chem 198329;538
[,lccowan i,IW
ril ".^.""",."", f ***,""" 3 F.cs.1i o 4r. Clh Bi..h,.r 1069 6t24-7
4 Trinde. P Ann Cln Biochern 1969: 6:24 7
T=L---l "-,,',".". l;;-n ,'"^,".,
PACK PRESENTATION
Revision No.: 7- FBCER , TGL
Date of Issue : 24l11/2ors
120211 5x20ml
tso9001 lso 134n5
QUATIrySYSTEM CERTIFIED 120212 1x5ml
1202'13 10x50ml