<Grba

-E-rrffi)t
W6b6it6 : www.edamannh6im.com

L!QUIXX
TOTAL PROTEIN ((
Biuret Method, End Point @
INTENOEDUSE SPECIiT EN COLLECTION AI{D }IANDLING
Diagnostic r€agent for quantilative l, y,lro determination of Use unheamolytic serum, plasma (heparin, EDTA), unne.
Iotal Protein jn human serum, plasma and urine. It is recommended lo follow NCCLS procedures (or similar
standardized conditions).
CLINICAL SIGNIFICANCE Stablllly
Tolalproteinisusefulformoniloring grosschanges inprotein 6days at 20-25"C
levels caused by various disease slates. lt is usually at4-8'C
performed in conjunction with other lests such as serum al least one year
al -2O"C
albumin, liver functaon tesls or protein electrophorcsis. An Discard contaminated specimens,
albumin/globulin ratio is oflen calculated lo oblain add tional
anlormalion.
lncreased levels of serum protein are observed in ASSAY PAMI' ETERS
dehydralion, multiple myeloma and chronic li\,er disease.
Decreased leyels are encounlered in rcnal diseases and End point
lerminal liEr failue W ave le n gth 1 (nm ) 546
Wavelength 2(nm )
METHOOOLOGY
Sam ple volum e(pl) 10 120
The peplide bonds of protein rcacl with copper it ions in
comple! (biuret reaction).
alkaline solution lo form blue-violel Reagent volu m e(ul 500 / 1000
Each copper ion complering with 5 or 6 peptide bonds. ln cu batio n temp.("C) 37
Tartrrete is addedas astabiiizer whik{lodi{reisrrs€dlofr€rrsf,t lncubation tim e(m in. 10
aulo-reduction of lhe alkaline coppercomple)c The color formed
Norm al Low (q/d I 6.4
is propo onalto the prolein concentration and is measured al
546nm (520 - 560nm) NormalHish(q/dl 8.3
Linearily Low{g/dl 0
REAGENT COMPOSITION Linearity hiqh(o/dl) 15
R.agent I :Toial Protein Reag.nt Conc. of Sta n da rd (q/d l) 6.0
CooDer lisulDhate 19 mmol/L Blank with Reaoenl
Potassium Sodium Tarlarate 43 mmol/L Absorbance lim it (lllax.) 0.200
30 mmol/L Units q/dl
Sodium Hvdroxide 600 mmol/L
Progranhe pararnelerc lor speclfic clinical analysers are
Tobl Proteh Standard available on rsquest.
Prcldn Slsdard I 6.0

REAGENT PREPARATIO}I EXPECTED VAI-UES

R€agenls are liquid, ready lo use, (s/dD
6.4 8.3
STABILITYANO STORAGE
The unopenod rcagents are stable till the expiry date staled on
3.6 - 6.0
the bottle and kit lab€lwhen stored at2-8'C.
4.6 - 7.0
4.4-7_6
Rl : afr6r op€ning is stable till the 6piry date stal€d on the bottte
and kit labelwhen stored al2-25'C in dark. avoid coniamination.
5.1 - 7.3
I - 2 years 5.6 - 7.5
Ril st ndardr an6r opsning is stable till lhe expiry date stated
6.0-8.0
on the botfu and kit lab€lwhen stored al2-{'C in dark, avoid
It .3 r€comEnded that 6ech laboratory veiify thl3 rano€ o.
*Keepthe
Standard vial plugged afteruse, in orderto derivas ral€rcnce interval forthe population ii seryes.
a\/oid debrioration.

d Manufactured by : TRANSASIA BIO-MEDICALS LTD,, Natagarh Road, Vilage lratpur, Baddi, Dist. Sotan, (Hp) - 173205.
ln Technical Collaboration with : €RBA diagnosti<s Mannhcim GmbH .[.u.tr.,69,73, o - 6s2t9, f,.nnh.tm /c.m.ny
 ASSAY PROCEDURE PERFORMA}ICE DATA
Data contained within this section is representati\e of p€rformance
Pipetle into lubes marked Blank Slandard
on ERBA systems. Dala obtained in your laboralory may differ from
1000 !l 1000 u 1000 pl
20 pl Linearity: 15 g/dl
20 t1l M6asudng range: 0 15 g/dl
20 ul
lncubsts br 10 min. at 37'C. R6ad absorbance of the Stiandad lntra-assay precisbn
SD (9/dl) CV (%)
Wilhin run (n=20) (s/dl)
and each test at 546 nm( 520 - 560 nm ) against reag€nl blank.
Sample 1 4.914 0.o72 1.46
Sample 2 7.314 0.04 0.55
CALCULATIot|
Calculale lhe results as follows :

lnterassay p.€cis ion

(s/dl)
SD (g/dl) cv (%)
Concentration of
x standard (g/dD 5.'177 0.038 0.73
(s idD Ab""rb",*
"fs""d*d Sample 2 6.761 0.078 1 15

LINEARITY
it is recommend6d to
Upto 15 g/dl- For highBr values Coi,l PARISON
dilule the samples with normal saline and repeat A comparison between Liquto( TotalProtein (y) and a commerciatty
lhs assay. Multiply the final result with the dilution factor. a'railable test (x) using 40 samples gale following €sults:
y= 0.986x+ 0.163 g/dl r= 0.997
i{oTEs
WARNING AI{D PRECAUTIot.IS
1. Gross lipaemia may causs falsely €leyated results, A For,, yllro diagnoslic use. To be handled by entitted and
sample blank may be set upusing th6 following professionally educated person.
prccedure: To1.0ml of normal saline add 20!l Reagenl 'l contains 2.4 % sodium hydro)dde which is ctassitied as
ofsampl6 and read lhe absooance against saline corrosive and 0.5 % potassium iodide lrhich is classified as skin
blank. Substract th6 absorbance of sample blank and respiralory sensitizer.
from ths absorbance of test.

2. On automated analyzers the incubation time may be WASTE MANAGEMENT

Pleas€ refer to local legal requirements.
reduced lo as little as4 min. at 37"C.

3. Tlle reagent and sample lolumes may be altered REFERENCES

proportionally to accomodate various anatyzer
1.'l'leE, N.W. (Ed). Te{ book of ClinicalChemistry W.B.
Saunders, 1986 P 579
OUALITY CONTROL
2. Goodwin, J.F.et.al. Automation inAnal. Chem. Technicon
For qualitycontol ERBA NORM and ERBA PATH are recom-
Syumposia (1965), P 315 - 320.

hITERFERENCES 3-Flack, C.P. and Woollen, J.w. Clin.Chem. (1984),30,559.

Following substances do not inlerferc:
haemoglobin up to 7.5 q,'1, bilirubin uD to 40 mo/dt. tdgtycerides 4. Young, D.S. el.al. Clin. Chem. (1975),21, 351D 353D.
up ro 1500 mg/dt.
5. Friedman, R.B. Clin.Chem. (1980), 26,209D - 211D
SYU4',S:
The following symbols are us6d in the labeltang of
ERBA Mannh€im kits: PACK PRES EMTANO}I

E C€ i',YX;h"tT.?##" Code
Reagont-l
Total Protein
TotalProt6ln
Standard

E 120231 5 x 50ml 5 x 50ml

8 [T],',3;f'*,*") fE consurr rnsrructon ror us€

Revisior No.: 5- FBCER - PRO
Date oflssue : 25/09/2015
rI ,f *,*" o,0".'.
tso 9001 lso ,34&5
QUALTTYSYSTEM CERTIFIED
lpntvrmr,l I r'o* r"," @ co**,