DIALAB Produktion und Vertrieb von chemisch-teohnischen Produkten und Laborinstrumenten Gesellschaft m.b.H.

1Z NOE-Sued, Hondastrasse, Objekt M55, 2351 Wr. Neudorf, Austria

Phone: +43 (0) 2236 660910-0, Fax: +43 (0) 2236 660910-30, e-maii: office@dialab.at

TEST PROCEDURE
DIACAL AUTO Please refer to the reagent package inserts for instructions for use.
Lyophilized calibration serum for the use in tests for the quantitative in vitro
determination ofvarious analytes in human samples on photometric systems. LOT SPECIFIC CALIBRATOR VALUES
The concentrations of the calibrator analytes are lot-specific and stated in the value
|REF| Content sheet of the corresponding lot. Please refer to enclosed table with lot specific
calibrator values.
D98485 5 x 3 mL kit
Determinations were performed under standardized protocols using Dialab reagents
D98485SV 1 x 3 mL single vial and Diacal Auto master calibrator or reference materials.

For professional in vitro diagnostic u s e only. TRACEABILITY

The enclosed value sheet contains information about the traceability.
G E N E R A L INFORMATION
Shelf life 24 months W A S T E MANAGEMENT
Storage 2 - 8 °C Please refer to local legal requirements.

INTENDED U S E LITERATURE
Lyophilized calibration serum for the use in tests for the quantitative in vitro 1. State Dati F. Reference materials and guidelines for standardization of methods
determination ofvarious analytes in human samples on photometric systems, in laboratory medicine. In: Thomas L, editor. Clinical laboratory diagnostics. 1 st
ed. Frankfurt: TH-Book Verlagsgesellschaft; 1998. p. 1404-26
R E A G E N T COMPOSITION
2. Moss DW, Henderson AR. Enzymes. In: Burtis CA, Ashwood ER, editors. Tietz
Diacal Auto is a lyophilized calibrator based on human serum with chemical additives Textbook of Clinical Chemistry. 2nd ed. Philadelphia: WB Saunders Company;
and biological material of specified origin. 1994 p. 735-896.
3. Biosafety in Microbiological and Biomedical Laboratories. U.S. Department of
Analyte Origin Health and Human Services, Washington 1993 (HHS Publication No. [CDC] 93-
Albumin Bovine plasma 8395).
Alkaline phosphatase Placenta (human, recombinant)
ALAT / G PT Porcine (heart)
alpha-Amylase Porcine (pancreas)
Pancreatic amylase Porcine (pancreas)
ASAT / GOT Human recombinant
8°C

X
Cholesterol Bovine plasma
Cholinesterase Human serum

C€
Creatine kinase (CK) Rabbit miiscle
Gamma-GT Human recombinant 2"C
GLDH Bacterium, recombinant
LDH Porcine heart
Lipase Pancreas (human recombinant)
Triglycerides Chicken egg yolk

The concentration of the biological material does not exceed the maximum, lot specific
value concentration of the analyte.
M A T E R I A L R E O U I R E D B U T NOT P R O V I D E D
• Clinical chemistry analyser.
REAGENT PREPARATION
Open the vial very carefully, avoiding any loss of the lyophilized material.
Add exactly 3 ml of distilled water (inaccurate reconstitution of the calibrator can
cause erroneous results).
Close the vial carefully and let it stand for 30 minutes, swirling occasionally.
Dissolve contents completely by swirling gently, avoiding the formation of foam.
Do not shake!

Transfer corresponding quantity needed for calibration into a clean sample cup and
treat it the same way as patient samples.
Defrost reconstituted, frozen aliquots bf the reconstituted Diacal Auto protected from
light at room temperature ( 1 8 - 2 5 °C) until they are completely thawed. After thawing,
gently swirl for complete homogerlization and use for calibration immediately
afterwards. use.

S T O R A G E AND S T A B I L I T Y
Storage: at 2 - 8 °C

Stability: until indicated date of expiration

Stability after reconstitution:

-20 °C +4 °C + 25 °C

Bilirubin (in the dark) 14 days 8 hours 3 hours

Other analytes 30 doys 2 days 8 hours

Once reconstituted, Diacal Auto calibrator can be used within the period reported in the
table above if stored tightly closed at the indicated temperature and bacterial
contamination is avoided.
Freeze only once!

Criterion for the stability stated is a recovery within i 5 % of the initial value.

W A R N I N G S AND P R E C A U T I O N S
1. Each individual blood donation used for production of Diacal Auto was found to
be non-reactive when tested with FDA-approved methods or CE-accepted
methods for HBsAg, anti-HIV i+2 and anti-HCV. As there is no possibility to
exclude definitely that products derived from human blood transmit infectious
agents, it is recommended to handle Diacal Auto with the same precautions used
for patient specimens.
2. Diacal Auto contains biological material of specified origin. The calibrators should
be handled as potentially infectious and with the same precautions used for
patient specimens.
3. Please refer to the safety data sheets and take the necessary precautions for the
use of calibrators and controls.
4. For professional use only!

F D11_V03 Page 1 of1 Rev.05, 2020-03-20

Diacal Auto Lot 0852001
Exp. 2021-12-31
Universal calibration serum

CC
Universal-Kalibrationsserum
Serum de calibration universel
Suero de calibracion universal
MyjibTHKajiHopaTop

Constituent Mcthod Traceability Calibration value linits

Bestandteil Methode Ruckfiihrbarkeit Kalibrationswert Einheit
Constituant Methode Tratpibilite Valeur de calibration Unite
Constituyente Metodo Trazabilidad Valor de calibracion Unidad
IlapaMerp MeTo/i IlpocjiejKHBaeMOCTb rHaHCHiic Emut.

ALB bromocresol green B R M - D A 470

Bromcresolgrun
Albumin vert de bromocresol 3,57 g/dL
Album ine verde de bromocresol 35,7 g/L
Albumina BpOMKpe30J10EbIH 3eJieHMM

AjibbyMHH

ALP D G K C (1970) 3 7 ° C D G K C recommended Ibrmulation 37 ° C

Test nach D G K C E m p f e h i u n g 446 U/L
Alkaline phosphatase M e t h o d e r e c o m m a n d . de la D G K C 7,43 gkat/L
Alkalische Phosphatase Test acuerdo a la D G K C

Phosphatase alcaline
Fosfatasa alcalina TFCC37°C IFCC recommended formulation 37 ° C
m,enoHHaa 4>0C4,aTa3a Test nach I F C C E m p f e h i u n g 226 U/L
M e t h o d e r e c o m m a n d . de la I F C C 3,76 )ikat/L
Test acuerdo a Ia I F C C

ALT/GPT IFCC 37 ° C
w i t h pyridoxal phoshate 37°C Origina! IFCC formulation

AJIT mit Pyridoxalphosphat 37°C Original IFCC Formulierung 100,0 U/L

avec phosphate de pyridoxal 37°C f o r m u l e originale de 1TFCC 1,67 gkat/L
Alanine Aminotransferase / con piridoxalfosfato 37°C original formula I F C C

G l u t a m i c P y r u v i c Transaminase c nHpa^oKcanb(J)oc4)aTo.M 37°C

Alaninaminotransferase /
Glutamat-Pyruvat-Trans-aminase IFCC 37 ° C
L'alanine-aminotransferase / without pyridoxal phoshate 3 7 ° C modified IFCC formulation, e N A D H

g l u t a m a t e - p y n i valc-Iransam i nase ohne Pyridoxalphosphat 37°C moditlzierte IFCC Formulierung, e N A D H 103 U/L
Alanino Aminotransferasa / sans phosphate de pyridoxal 3 7 ° C m o d i f i e f o r m u l e de 1TFCC, c N A D H 1,71 gkal/L
Transaminasa G l u t a m i c o P i r u v i c a sin piridoxalfosfato 37°C modifica formula IFCC, e N A D H

AjiaiiHHaMHHOTpaHC(|)cpa3a / 6e3 iiHpHAOKcajibtJjocfJiaTa 37°C

r j j y r a - M aT-n « p y B a r r p a B c a M nna30H

AST/GOT IFCC 37 "C

with pyridoxal phoshate 37°C Original IFCC formulation

ACT mit Pyridoxalphosphat 37°C Original IFCC Formulierung 100 U/L

avec phosphate de pyridoxal 37°C f o r m u l e o r i g i n a l e de 1TFCC 1,66 gkat/L
Aspartate Amino-transferase / con piridoxalfosfato 37°C original formula IFCC

G l u t a m i c O x a l a c e l i c Trans-aminase c niipimoKcajib^oc^aroM 37°C

Aspartat-amino-transferase /
Glutamat-Oxalacctat-Trans-aminase IFCC 37 ° C
l'aspartate-aminotransferase / without pyridoxal phoshate 3 7 ° C modified IFCC formulation, t N A D H

g!utamate-oxa j oacetate-transami nase ohne Pyridoxalphosphat 37°C modifizierte IFCC Formulierung, e N A D H 105 U/L
Aspartato Aminotransferasa / sans phosphate de pyridoxal 3 7 ° C m o d i f i e f o r m u l e d e 1TFCC, c N A D H 1,75 gkat/L
Transaminasa G l u t a m i c o Oxalacetica sin piridoxalfosfato 37°C modifica formula IFCC, e N A D H

AcnapTaTaMHHOTpaHC(J)epa3a / 6e3 nnpHHOKcajib^octJiaTa 37°C

H i j T a M at-oKcajioaiicTaTTpan caMH-Ha3a

AMY EPS-G7 O r i g i n a l IFCC f o r m u l a t i o n 37 ° C

O r i g i n a l IFCC F o r m u l i e r u n g 181 U/L
a-Amylase f o r m u l e o r i g i n a l e de 1TFCC 3,02 gkat/L
a-Amilasa original formula I F C C

a-AMHJia3a

CNTG3 Dialah formulation, e p-Nitrophenol 37 ° C

Dialah Formulierung, e p-Nitrophennl 169 U/L
f o r m u l e de D i a l a b , z p - N i t r o p h e n o l 2,82 gkat/L
formula Dialab, e p-nitrofenol

Diacal Auto, 0852001 Rev.01, 18.03.2020

 Lot 0852001
Diacal Auto
Exp. 2021-12-31

CC
Universal calibration serum
Universal-Kalibrationsserum
Serum de calibration universel
Suero de calibracion universal
MyjibTHKajrnbpaTop

Traceability Calibration value Units

Constituent Method
Riickfiihrbarkeit Kalibrationswert Einheit
Bestandteil Methode
Tra^abilite Valeur de calibration Unite
Constituant Methode
Trazabilidad Valor de calibracion Unidad
Constituyente Metodo
IIpOCflejKHBaeMOCTb 3HaHeHHe EflHH.
napaiweTp MeTOfl

37°C
P-AMY EPS-G7
modified. IFCC. z p-Nitrophenol

Pancreatic a-Amylase I F C C modifizierte, z p-Nitrophenol 168 U/L

Pancreas-a-Amylase modifie de 1TFCC, z p-Nitrophenol 2,79 pkat/L

a-Amylase pancreatique modifica IFCC. z p-nitrofenol

a-Amylase pancreatica
a-llaHKpeaTHuecKaa aMHJta3a

D-BIL Jendrassik-Grof
2,37
DCA mg/dL
Direct Bilirubin /IXA 40,6 pmol/L
Direktes Bilirubin 23,7 mg/L
Bilirubine directe
Bilirrubina directa Jendrassik-Grof 2,45 mg/dL
I l p a M O H SHJIHpyOHH 41,9 pmoI/L
24,5 mg/L

T-BIL
DCA 4,03 mg/dL
Bilirubin total flXA SRM916a 68,9 pmol/L
Bilirubin Gesamt 40,3 mg/L
Bilirubine
Bilirrubina Jendrassik-Grof Jendrassik-Grof 5,32 mg/dL
OSwnii 6 H J I H P V 6 H H 91,0 pmol/L
53,2 mg/L

BUN Urease-GLDH U V SRM 909b Level 1 49,5 mg/dL

urease-GLDH U V 17,6 mmol/L
Urea N ureasa G L D H U V 0,495 g/L
Harnstoff-N ypea3HMit - rajjr y<i>
UreeN colorimetric, Berthelot SRM 909b Level 1 52 mg/dL
A 3 0 T KpOBH 18,5 mmol/L
0,52 g/L
CA AAS
Arsenazo I I I , CPC 2,57 mmol/L
Calcium arsenazo III, CPC 5,15 mEq/L = mval/l
Calcio ApceHa30 I I I , OK<I> 10,3 mg/dL
Kajii>uHH

CHE opt. DGKC, butyrylthiocholine DGKC rccommended formulation 37 °C

opt. D G K C , Butyrylthiocholin Tesi nach DGKC Empfehlting
Cholinesterase D G K C opt., butyrylthiocholine Methode recomioand. de la DGKC 4558 U/L
Cholinesterase DGKC opt., butiriltiocolina Test acuerdo a !a DGKC 76,0 pkat/L
Colinesterasa E\THpHJIXOJtHHOBbIH •

XojTHH3CTepa3a N.

CL
Thiocyanate
Chloride Thiocyanat SRM 999 mmol/L
Chlorid Tiocianato 102 =mEq/L
Chlorures TnouuaHaTHbiH
=mval/L
Chloruro
XnopHjM

CHOL CHOD-PAP GC-IDMS

Cholesterol
168 mg/dL
Cholesterin
4,34 mmol/L
Cholesterol
1,68 g/L
Colesterolo
XojiecTepitH

Diacal Auto, 0852001 -2 / 5 -

Rev.01, 18.03.2020
Diacal Auto Lot 0852001
Exp. 2021-12-31
Universal calibration serum
Universal-Kalibrationsserum
Serum de calibration universel
Suero de calibracion universal
MyjibTHKajindpaTop
CC
Constituent Method Traceability Calibration value Units
Bestandteil Metbode Riickfiihrbarkeit Kalibrationswert Einheit
Constituant Methode Tra^abiltte Valeur de calibration Unite
Constituyente Metodo Trazabilidad Valor de calibracion Unidad
IlapaMeTp MeToa ripocjie%HBaeMOCTb maicHite F.USH.

CK 37 °C
D G K C opt. Original IFCC formulation

Creatine kinase IFCC 37°C Originai IFCC Formulierung

Creatinkinase formule originale de l'IFCC 363 U/L

Creatine kinase original formula IFCC 6,05 gkat/L
Creatin-quinasa
S'"» t-
KpeaTHHKHHaaa

C RE A enzymatic, PAP GC-IDMS

enzymatisch, PAP 3,90 mg/dL
Creatinine enzymatique, PAP 345 gmol/L
Kreatinin enzimatico, PAP 39,0 mg/L
Creatinine <I>epMeHTaTHBHI,IH
Creatinina Jaffe with compensation GC-IDMS
KpeaTHHHH Jaffe mit Kompensation 4,35 mg/dL
Jaffe avec compensation 385 gmol/L
Jaffe con compensacion 43,5 mg/L
iltj)4)e c KOMnencauMeii
Jaffe without compensation GC-TDMS
Jaffe ohne Kompensation 3,87 mg/dL
Jaffe sans compensation 342 gmol/L
Jaffe sin compensacion 38,7 mg/L
^4><Jjeoc3 KOMneHcauHH

FE SRM 682
Ferene 188 gg/dL
Iron OepeH 33,6 gmol/L
Eisen 1,88 mg/L
Fer
Hierro
)Kejie30

GGT Szasz Original form. Persijn/v.d. Slik 1976 37 °C

Original Form. Persijn/v.d. Slik 1976 128 U/L
y-GT form. originale dc Persijn/v.d. Slik 1976 2,14 gkat/L
v-rr original form. Persijn/v.d. Slik 1976

stand. to IFCC Original IFCC formulation 37 °C

Original IFCC Formulierung 145 U/L
formule originale de l'IFCC 2,41 gkat/L
original formula IFCC

GLDH D G K C (1970) 37°C 37 °C

DGKC recommended formulation

Glutamate dehydrogenase Test nach DGKC Empfehlung 27,0 U/L

G lutamatdehy dro genase Methode recommand. dc la DGKC 0,451 gkat/L
Glutamate-deshydrogenase Test acuerdo a la DGKC

Glutamato deshidrogenasa
rjiyTaMaT^;ernjiporeHa3a

GLUC ID-MS
H K G6PDH TK G6PDH 192 mg/dL
Glucose GOD-PAP 10,6 mmol/L
Glucosa 1,92 g/L
rjnoK03a

HBDH DGKC37°C DGKC recommended formulation 37 °C

Test nach DGKC Empfehlung 283 U/L
a-HBDH Methode recommand. de Ia DGKC 4,71 gkat/L
a-rE^r Test acuerdo a la DGKC

Diacal Auto, 0852001 -3/5- Rev.01, 18.03.2020

Diacal Auto Lot 0852001
Exp. 2021-12-31

CC
Universal calibration serum
Universal-Kalibrationsserum
Serum de calibration universel
Suero de calibracidn universal
MyjibTHKajiH6paTop

Constitucnt Method Traceability Calibration value Units

Bestandteil Methode Ruckfuhrbarkeit Kaiibrationswert Einheit
Constituant Methode Tra^abilite Valeur de calibration Unite
Constituyente Metodo Trazabilidad Valor de calibracion Unidad
IlapaMci p Meroij IlpocaeacHBaeMocTb ma-uinic E/IHH.

LACT enzymatic ( L D H ) U V Primary reference material

PrimSres Referenz Material 28,0 mg/dL

Lactate Materielle de reference primaire 3,10 mmoI/L
Lactat Material de reftrencia primario 280 mg/L
Lactato
JlaKTaT

LDH L D H - L : IFCC / D G K C (1994) Original IFCC formulation 37 °C

Original IFCC Formulierung 276 U/L

Lactate dehydrogenase formule originale de l'IFCC 4,60 pkat/L
Lactatdehydrogcnase original formub IFCC

Lactate deshydrogenase
Lactacto deshidrogenasa LDH-P:DGKC(1970) DGKC recommended formulation 37 °C

jiaKTaT^eniaporeHa3oii resi nach DGKC Empfehlung 460 U/L

Methode recommand. de la DGKC 7,66 pkat/L
Test acuerdo a la DGKC

LPS Colorimetric test Molar extinction coefficienl 37 °C

Farbtest Molarer Extinktionskoefl1izicnt 95,6 U/L

Lipase test colorimetrique Coetficient mnlaire d'extinction 1,59 pkat/L
Lipasa test-color Coeficiente melar de la extinci6n

JlHna3a KojIOpHMeTpHteCKHH TeCT

MG xylidyl blue method AAS

Xylidylblau-Methode 1,17 mmol/L
Magnesium methode au bleu de xylidylc 2,35 mval/L
Magnesium metodo azui de xilidil 2,85 mg/dL
Magncsio KCHJIWUMOBbIH CHHHH

ManiMH

P03
Molybdate U V Internal Standard
Inorganic phosphate Molybdat U V Interner Standard 5,65 mg/dL
Phosphat anorganisch Molibdato U V Standard interne 1,82 mmol/L
Phosphore inorganique MojinoaaT y<b Standard interno 56,5 mg/L
Fosforo inorganico
<l>oc(|)op

TG GC-IDMS
-
GPO-PAP
Triglycerides 136 mg/dL
Triglyceride 1,53 mmol/L
Triglycerides 1,36 g/L
Triglyceridos
TpnrjinuepHflH

TP Biuret, with sample blank Modified Biuret method

Biuret, mit Probenlccrwert 5,25 g/dL
Total protein Biuret, avec echantillon temoins 52,5 g/L
Total Protein Biuret, con muestra blancos
Protcines totales BnypeTOBblH C CbIBOpOTOHHbIM 6jtaHKOM

Proteinas totales Biuret, without sample blank Modifted Biuret method

0 6 I U H H SeJioK Biuret, ohne Probenleerwert 5,75 g/dL
Biuret, sans echantillon temoins 57,5 g/L
Biuret, sin muestra blancos
EuypeTOBbtii 6e3 c b i B o p o T O H H o r o onaHKa
5,51 mg/dL
UA Uricase, A O X , TOOS GC ID-MS
328 pmol/L

Uric A c i d 55,1 mg/L

Harnsaure Uricase, T B H B A GC ID-MS 5,44 mg/dL

Acide urique 323 pmol/L

Acido urico 54,4 mg/L

M o n e B a s KHC.ioTa

Diacal Auto, 0 8 5 2 0 0 1 -4/5- R e v . 0 1 , 18.03.2020

Diacal Auto Lot 0852001
Exp. 2021-12-31
Universal calibration serum

Universal-Kalibrationsserum

Serum de calibration universel

Suero de calibracion universal

MyjibTHKann6paTop
CC
Constitucnt Metli od Traceability Calibration value l'riil s

Bestandteil Methode Ruckfiihrbarkeit Kalibrationswert Einheit

Con$tituant Methode Tra^abilite Valeur de calibration Unite

Constituyente Metodo Trazabilidad Valor de calibracion Unidad

IlapaMeTp MeTo/t IIpocJie%HBaeMocTb sna'mnte F.UJU.

UIBC
Internal Standard 200 Pg/dL
Unsat. iron-binding capacity Ferrozine / Ferene Interner Standard 35,9 pmol/L

Latente Eisenbnd. Kapazitat Fcrrozin / Ferene Standard interne 2,00 mg/L

Cap.fixation du fer, insature Ferrozine / Ferene Stadard intemo

Cap. Insatu. fijacion hierro Ferrozina / Ferene

UREA Ureasc-GLDH U V SRM 909b Level 1 106 mg/dL

urcase-GLDH U V 17,6 mmol/L

Harnstoff ureasa G L D H U V 1,06 t/L

Uree ypea3HbiH-rjTyTaMaTjrerHgporeHa3Hbiii

MoneBHHa colorimetric, Berthelot SRM 909b Level 1 111 mg/dL

EepTJio 18,5 mmol/L

1,11 g/L

S h o r t forms:

DGKC Deutsche Gesellschaft ftir Kiinische Chemie

IFCC Inlemational Federation of Clinical Chemistry
SCE ScauJinavian Committee o f Enzymes
SFBC Socicte Francaise dc Biologic Clinique
NVKC Nederlandse Vereniging voor Klinidche Chemie
SEQC Sociedad Espanola de Quimica Clinica

AAS Atomic absorption Spectromelry

Atom absorbtions Spektrometrie
Spccirometrie d'adsoption atomique
Espectroscopia de absorcion atomica
ATOM NornomeHne c n eKTpOM etpH u

GC-IDMS Gas-t'hromatography isoiope dilution spectrometry

Gaschromalographische Isotopenverdiinnung-Massenspektrometrie
Spectrom&ric de dilution d'isotope de Gaz-Chromatographie
Spectrometry de la dilusion del isotopo de la Gas-Cromatografi'a
i a'iOP,an xpoMaTorpa4iHa iiaoTOnHoro pa36aB.iCHHJi cncKTpoMeTpHH

ID-MS Isotope dilution - mass spectrometry

Isotopenverdiinnung-Massenspektrometrie
Spectrometrie de masse a dilution isotopique
Espectronietn'a de masas con diiucidn isotdpica
H30TonHoro pasfiaBneHHa Macc-cneKTpoMeTpHH

ERM-DA470 Europcan Refercnce Material D A 4 7 0

SRM Standard Refercnce material

Slandardisiertes Referenzmaterial
Matcrielle de reference Standard
Material de referencia estandar
CiaHflapTHbifi CnpaBotHwe MaTepna.ibi

INSTAND Gesellschaft zur Forderung der Oualitatssicherung in medizintschen Laboratorien e.V., Diisseldorf / Germany

Notes:
• Data not availablc at the time of printing. Please inquire.
Daten zum Zeitpunkt des Drucks nicht verfilgbar. Bitte nachfragen.
Donnees non disponible a la date d'impression. Pidre de se renseigner.
No sc disponia de informacion en el momento en que se imprimio este prospeeto. Consulte cualquier dulda

** In dicsem Sollwertzcttel wird immer ein Komma als Dezimaltrennzeichen verwendet. Tausendertrennzcichen werden nicht verwendet.
A comma is always used in this value sheet as decimal separator. Separators for thousands are not used.
Dans ce fiche des valeurs de references, la virgule represente le caractere separateur decimal. Des separateurs pour 'mille" ne sont pas employes.
La coma rcpresenta el caracter separador decimal. No se utilizan caracteres para separar el 'mil'.
DTO COHCOK JiMTepaTypbi Bceraa 3anaxan Hcnojibiyerca B KatecTBe neorrHiHoro pa3;tejiHTe.iH. CenapaTOpbi JIJIH TMCSI He Hcno.ib3yiOTcn.

Diacal Auto, 0852001 -5/5- Rev.01, 18.03.2020