Handling of Controls Calibrators and ISE Solutions

Quick Reference Guide

Calibrators, Controls,
ISE Solutions &
Maintenance Solutions

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 Handling of Controls Calibrators and ISE Solutions

Calibrators
Calibrator Tests
01) Albumin 14) Glucose
02) Alkaline Phosphatase, 15) HBDH
03) ALT 16) Inorganic Phosphorous
04) Amylase 17) Iron
05) AST 18) Lactate
System Calibrator
06) Bilirubin Total 19) LDH
(One Calibrator for 26 Chemistries)
07) Bilirubin Direct 20) Lipase
Catalog = 66300
08) Calcium 21) Magnesium
Pack = 20 x 5 ml
09) Cholesterol 22) Total Protein
10) Cholinesterase 23) Triglyceride,
11) CK-NAC 24) UIBC
12) Creatinine 25) Urea
13) GGT 26) Uric Acid
CK-MB Calibrator
CK-MB
Catalog = ODR30034 - Pack = 6 x 1 ml
HDL Calibrator
HDL
Catalog = ODC0011 - Pack = 2 x 3 ml
LDL Calibrator
LDL
Catalog = ODC0012 - Pack = 2 x 1 ml
CO2 Calibrator
CO2
Catalog = ODC0012 - Pack = 6 x 25 ml
01) ASO 06) IgA
02) C3 07) IgG
SERUM PROTEIN MULTI-Calibrator
03) C4 08) IgM
Catalog = ODR3021 - Pack = 6 x 2 ml
04) CRR Normal (OSR6147) 09) Transferrin
05) Ferritin
RF Calibrator
RA
Catalog = ODC0028 - Pack = 5 x 1 ml
CRP Calibrator High Sensitive
CRP Highly Sensitive (OSR6199)
Catalog = ODC0027 - Pack = 5 x 2 ml
CRP Calibrator Normal
CRP Normal (OSR6199)
Catalog = ODC0026 - Pack = 5 x 2 ml
MICRO-ALBUMIN Calibrator
Mico-Albumin
Catalog = ODR3024 - Pack = 5 x 2 ml
PRE-ALBUMIN Calibrator
Pre-Albumin
Catalog = ODR3029 - Pack = 5 x 2 ml
01) Ceruloplasmin 04) α-1 acidglycoprotein
SERUM PROTEIN MULTI-Calibrator 2
02) Haptoglobin. 05) α-1 antitrypsin
Catalog = ODR3023 - Pack = 5 x 2 ml
03) β-2 microglobulin
D-Dimer Calibrator
Catalog = ODR3033 D-Dimer
Pack = 2 x 2.5 ml + 2 x 0.5 ml
ISE Low Serum Standard
01) N
Catalog = OE66317 - Pack = 4 x 100 ml
02) K
ISE High Serum Standard
01) C
Catalog = OE66316 - Pack = 4 x 100 ml
01) Na
ISE Low / High Urine Standard
02) K
Catalog = OE66315 - Pack = 4 x 100 ml
03) Cl
05) Urea OSR6134 /
01) α-Amylase OSR6106 / OSR6182
OSR6141
02) Calcium OSR6113 / OSR6176 /
Urine Calibrator 06) Uric Acid OSR6136
OSR61117
Catalog = ODC0025 - Pack = 6 x 8 ml 07) Creatinine OSR6178 /
03) Glucose OSR6121
OSR61204
04) Phosphorous OSR6122
08) Magnesium OSR6189

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Controls
Calibrator
01) APO A1 18) IgA
02) Albumin 19) IgG
03) Alkaline Phosphatase, 20) IgM
04) ALT 21) Iron
Control Serum 1
05) Amylase 22) Lactate
(One Control for 34 Chemistries)
06) AST 23) Lithium
Catalog = ODC0003
07) Bilirubin Total 24) LDH
Pack = 20 x 5 ml
08) Bilirubin Direct 25) Lipase
09) Calcium 26) Magnesium
Control Serum 2
10) Cholesterol 27) Total Protein
(One Control for 34 Chemistries)
11) Cholinesterase 28) Triglyceride,
Catalog = ODC0004
12) CK-NAC 29) UIBC
Pack = 20 x 5 ml
13) Creatinine 30) Urea
14) GGT 31) Uric Acid
15) Glucose 32) Na
16) HBDH 33) K
17) Inorganic Phosphorous 34) Cl
CK-MB Control Level 1
Catalog = ODR30035 - Pack = 9 x 2 ml
CK-MB
CK-MB Control Level 2
Catalog = ODR30036 - Pack = 9 x 2 ml
CRP Control Level 1 + Level 2
CRP Highly Sensitive (OSR6199)
Catalog = ODC0013 - Pack = 4 x 2 ml
HDL / LDL Control Level 1 + Level 2 01) HDL
Catalog = ODC0005 - Pack = 6 x 5 ml 02) LDL
HBA1C Control Level 1 + Level 2
HBA1C
Catalog = B12396 - Pack = 4 x 1 ml
01) ASO
02) C3
SERUM PROTEIN Control Level 1
03) C4
Catalog = ODC0014 - Pack = 6 x 2 ml
04) CRR Normal (OSR6147)
05) CRP Highly Sensitive (OSR6199)
SERUM PROTEIN Control Level 1
06) Ceruloplasmin
Catalog = ODC0015 - Pack = 6 x 2 ml
07) IgA
08) IgG
SERUM PROTEIN Control Level 1
09) IgM
Catalog = ODC0016 - Pack = 6 x 2 ml
10) Pre-Albumin
11) RF
D-Dimer Control Level 1 + Level 2
D-Dimer
Catalog = ODC0029 - Pack = 4 x 0.5 ml

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SYSTEM CALIBRATOR (66300)

 Calibrator Pack = 20 x 5 ml
 Allow the vial to Equilibrate at Room temperature before opening.
 Add 5.0 mL Deionized water (use pipette).
 Invert vial 3 times and then leave it for 10 minutes.
 Put this vial on mixing roller for 30 minutes.
 Do not shake vial it cause foaming.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.
 Store at 2-8° C.

Storage and Stability:

Tests -20 °c 2-8 °c
ALP,ALT,ASTAMY,CK-NAC,HBDH,LDH Not Recommended 8 Hours
ALB, CRET, CHOL, GLU, TP, TG, UREA, URIC ACID, BILURIBIN. 1 Month 30 Hours
NOTE: For ALP, it is recommended that the reconstituted serum be allowed for at least 2 hours at 2-8 °C.

CONTROL SERUM 1 - Green Cap (ODC0003)

 Control Serum Level 1 Pack = 20 x 5 ml
 Add 5.0 ml DI water, Equilibrate to room temp.
 Invert the vial 3 times and stands for 10 minutes.
 Put the vial on mixing roller for 30 minutes.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.
 Store at 2-8 °C.

Storage and Stability:

Tests -20° c 2-8 °c

TBIL, DBIL. 5 Days 24 Hours

ALP, ALT, AMY, AST, CK-NAC, LDH, TG, 1 Month 2 days

ALB ,CL, CHOL, CRET, GLU, HDL, MG, TP, LITHIUM, K, Na, Mg,
1 Month 7 Days
UREA, URIC ACID, IgG, IgM, IgA,
NOTE: For ALP, it is recommended that the reconstituted serum be allowed for at least 2 hours at 2-8 °C.

CONTROL SERUM 2 - Red Cap (ODC0004)

 Control Serum Level 2 Pack = 20 x 5 ml
 Add 5.0 ml DI water, Equilibrate to room temp.
 Invert the vial 3 times and stands for 10 minutes.
 Put the vial on mixing roller for 30 minutes.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.
 Store at 2-8°C.

Storage and Stability:

Tests -20°c 2-8°c

TBIL, DBIL, 5 Days 24 Hours

ALP,ALT,AMY,AST, TG, LDH, CK-NAC, 1 Month 2 days

ALB, CAL, CHOL, CL, CRET, GLU, HDL, TP, UREA, URIC ACID, IGA,
1 Month 7 Days
IgG, IGM.
NOTE: For ALP, it is recommended that the reconstituted serum be allowed for at least 2 hours at 2-8 °C.

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CK-MB Calibrator (ODR3034)

 Pack = 6 x 1 ml
 Allow the vial to Equilibrate at Room temperature before opening.
 Add 1.0 mL Deionized water (use pipette).
 Invert vial 3 times and then leave it for 10 minutes.
 Put this vial on mixing roller for 30 minutes.
 Do not shake vial it cause foaming.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability:

Tests 15-25°c 2-8°c -20°c

CK-MB 8 Hours 5 Days 4 Weeks

CK-MB Controls

Product Catalog Pack

CK-MB Control Level 1 ODR30035 9 x 2 ml
CK-MB Control Level 2 ODR30036 9 x 2 ml

 Add 2.0 ml DI water, Equilibrate to room temp.

 Invert the vial 3 times and stands for 10 minutes.
 Put the vial on mixing roller for 30 minutes.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability:

Tests 15-25°c -20°c 2-8°c

CK-MB 8 Hours 4 Weeks 5 Days

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HDL Calibrator (ODC0011)

 Pack = 2 x 3 ml
 Add 3.0 mL of sterile deionised water at 15…25°C
 Gently mixing for 30 minutes. Avoid foaming.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability:

Tests -20°c 2-8°c

HDL 30 Days 7 Days

NOTE: The Reagent Blank must be performed every 7 days for HDL.

LDL Calibrator (ODC0012)

 Pack = 2 x 1 ml
 Add 1.0 mL of sterile deionised water at 15…25°C
 Gently mixing for 30 minutes. Avoid foaming.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability:

Tests -20°c 2-8°c

LDL 30 Days 7 Days

HDL / LDL - Two Levels in One Pack (ODC0005)

 Pack = 6 x 5 ml (Control Level 1 and Level 2, Three vials of 5 ml each level)
 Add 5.0 mL of sterile deionised water at 15…25°C
 Gently mixing for 30 minutes. Avoid foaming.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability:

Tests -20°c 2-8°c

HDL and LDL 30 Days 7 Days

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HBA1C Calibrator (Included in the Kit)

 Pack = 5 x 2 ml
 Carefully remove the cap and stopper from each bottle, avoiding any loss of lyophilized material.
 Add 2.0 mL of sterile deionised water at 15…25°C to the lyophilized material using a calibrated
volumetric pipette.
 Replace the caps and stoppers on each bottle. Care must be taken to ensure that the caps and stoppers are
matched to the correct bottle.
 Dissolve the contents completely by gently mixing for 30 minutes.
 Vortex each bottle for 5 seconds at medium speed. Avoid foaming. Ensure that all lyophilized material is
reconstituted.
 When reconstitution is done make aliquots securely cap and mark each aliquot tube and freeze at -20° C.
 Thaw the Aliquote and mix thoroughly before use.
 Frozen calibrators should be thawed only once.
 After thawing, vortex for 5 seconds at medium speed.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability:

Tests 15-25°c 2-8°c -20°c
30 Hours
HBA1C Calibrator 8 Hours 1 Month
(1 and Half Day)

NOTE:
1) Recalibrate HBA1C every 14 days
2) Calibrators are lot-specific and should not be interchanged. Calibrators DO NOT require
pre-treatment with hemolyzing reagent prior to assay.

HBA1C Control Two Levels in One Pack (B12396)

 Pack = 4 x 1 ml
 Controls are Liquid and Ready to use (manufactured for Beckman by Canterbury Scientific, New Zealand)
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.
 When Open the vial make aliquots securely cap each aliquot tube and freeze at -18° C.
 Thaw the Aliquote and mix thoroughly before use.
 Do not Re-Freeze or Re-Thaw the same tube.

Storage and Stability:

Tests 2-8°c -18 °c

ExtendSURE HBA1C Control 8 Days 30 Days

Haemolysate Application
Pre-treat samples and controls by dilution of whole blood with Hemolyzing Reagent in a ratio of 1:100 (for
example 10 μL of sample or control plus 1000 μL of Hemolyzing Reagent Cat. No. 472137). Mix thoroughly,
avoid foaming, and incubate for 5 minutes at room temperature before use.

Whole Blood Application

Reconstituted controls should be placed on board the analyser without pre-treatment.

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SERUM PROTEIN MULTI-Calibrator (ODR3021)

 Calibrators 1 to 6 (2 ml each) = 6 x 2 ml
01) Calibrator 1 (White Cap)
02) Calibrator 2 (Yellow Cap)
03) Calibrator 3 (Orange Cap)
04) Calibrator 4 (Red Cap)
05) Calibrator 5 (Black Cap)
01) Calibrator 6 (Green Cap)
 Calibrators are ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture

Storage and Stability after opening of vial:

Tests 2-8°c

IgG, IgA, IgM, C3, C4, Transferrin, CRR Normal (OSR6147), ASO, Ferritin 30 Days

RF Calibrator (ODC0028)
 Calibrators 1 to 5 (1 ml each) = 5 x 1 ml
01) Calibrator 1 (White Cap)
02) Calibrator 2 (Blue Cap)
03) Calibrator 3 (Green Cap)
04) Calibrator 4 (Red Cap)
05) Calibrator 5 (Orange Cap)
 Calibrators are ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability after opening of vial:

Tests 2-8°c

All Levels of RF Calibrators 90 days

ITA Control Level 1 / Level 2 / level 3

Product Catalog Pack

Serum Protein Control (ITA 1) ODC0014 6 x 2 ml
Serum Protein Control (ITA 2) ODC0015 6 x 2 ml
Serum Protein Control (ITA 3) ODC0016 6 x 2 ml

 Controls are ready to use.

 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability after opening of vial:

Tests 2-8°c
CRP (OSR6199 – Highly Sensitive and OSR6147 - Normal) / RF / ASOT / IGA / IgG /
30 days
IgM / C3 / C4 / Ceruloplasmin / Pre-Albumin

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CRP Calibrator Highly Sensitive (ODC0027)

 Calibrators 1 to 5 (2 ml each) = 5 x 2 ml
01) Calibrator 1 (Cream Cap)
02) Calibrator 2 (Blue Cap)
03) Calibrator 3 (Red Cap)
04) Calibrator 4 (Brown Cap)
05) Calibrator 5 (Green Cap)
 For the zero calibrator saline should be used.
 Calibrators are ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability after opening of vial:

Tests 2-8°c

CRP (OSR6199) 90 days

CRP Calibrator Normal (ODC0026)

 Calibrators 1 to 5 (2 ml each) = 5 x 2 ml
06) Calibrator 1 (Cream Cap)
07) Calibrator 2 (Blue Cap)
08) Calibrator 3 (Red Cap)
09) Calibrator 4 (Brown Cap)
10) Calibrator 5 (Green Cap)
 For the zero calibrator saline should be used.
 Calibrators are ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability after opening of vial:

Tests 2-8°c

CRP (OSR6199) 90 days

CRP Control - Two Levels in One Pack (ODC0013)

 Pack = 4 x 2 ml (Control Level 1 and Level 2, Two vials of 2 ml each level)
 Controls are ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability after opening of vial:

Tests 2-8°c

CRP Highly Sensitive or Normal (OSR6199) 30 days

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MICRO-ALBUMIN Calibrator (ODR3024)

 Calibrators 1 to 5 (2 ml each) = 5 x 2 ml
01) Calibrator 1 (White Cap)
02) Calibrator 2 (Yellow Cap)
03) Calibrator 3 (Orange Cap)
04) Calibrator 4 (Red Cap)
05) Calibrator 5 (Black Cap)
 Calibrators are ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture

Storage and Stability:

Tests 2-8°c

MicroAlbumin 30 Days
NOTE: Micro-Albumin Control Not Available from Beckman Coulter.

PRE-ALBUMIN Calibrator (ODR3029)

 Calibrators 1 to 5 (2 ml each) = 5 x 2 ml
01) Calibrator 1 (White Cap)
02) Calibrator 2 (Yellow Cap)
03) Calibrator 3 (Orange Cap)
04) Calibrator 4 (Red Cap)
05) Calibrator 5 (Black Cap)
 Calibrators are ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture.

Storage and Stability:

Tests 2-8°c

PreAlbumin 30 Days
NOTE: Pre-Albumin Control values are included in ITA Control level 1 or 2 or 3.

SERUM PROTEIN MULTI-Calibrator 2 (ODR3023)

 Calibrators 1 to 5 (2 ml each) = 5 x 2 ml
01) Calibrator 1 (White Cap)
02) Calibrator 2 (Yellow Cap)
03) Calibrator 3 (Orange Cap)
04) Calibrator 4 (Red Cap)
05) Calibrator 5 (Black Cap)
 Calibrators are ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture

Storage and Stability:

Tests 2-8°c

α-1 acidglycoprotein, α-1 antitrypsin, β-2 microglobulin, Ceruloplasmin, Haptoglobin. 30 Days

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D-DIMER Calibrator (ODR3033)

 Pack = 2 x 2.5 ml + 2 x 0.5 ml
 D-DIMER Calibrator 1 – Liquid Ready to use.
 D-DIMER Calibrator 2 – Prepare as follows:
 Add .50 ml DI water, Equilibrate to room temp.
 Invert the vial 3 times and stands for 10 minutes.
 Put the vial on mixing roller for 30 minutes.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.
 Store at 2-8°C.

Storage and Stability:

Tests 15-25°c -20°c 2-8°c

D-Dimer Calibrator 2 1 Day 30 Days 28 Days

D-DIMER Control- Two Levels in One Pack (ODC0029)

 Control Level 1 and Level 2, Two vials of 0.5 ml each level = 4 x 0.5 ml
 Add .50 ml DI water, Equilibrate to room temp.
 Invert the vial 3 times and stands for 10 minutes.
 Put the vial on mixing roller for 30 minutes.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability:

Tests 15-25°c -20°c 2-8°c

D-Dimer Control 1 Day 30 Days 28 Days

Urine Calibrator (ODC0025)

 Pack = 6 x 8 ml
 Liquid Ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.
 Store at 2-8°C. DO NOT FREEZ

Storage and Stability:

Un-Opened Opened
Tests
2-8°c 2-8°c
α-Amylase, Calcium, Glucose, Phosphorous, Urea, Uric Acid, Upto Expiry on the
60 Days
Creatinine, Magnesium Vial

NOTE: Creatinine values may gradually decrease over the product shelf life.

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ISE Reagents
 Reagents are ready to use.

Storage and Stability:

Opened
Reagents Un Opened
2-25°c
Up to Expiry Date
ISE Buffer (66320) 60 Days
on Vial
Up to Expiry Date
ISE Mid Standard (66319) 30 Days
on Vial
Up to Expiry Date
ISE Reference (66318) 60 Days
on Vial

NOTE:
1. Each time you change the ISE solution; you prime that reagent and “Recalibrate” the ISE.
2. It is recommended not to use the previous / left over solution in the bottles when it is alarmed by
the system to change the bottle.

ISE Calibrators and other Solutions

 Calibrators are ready to use.
 Gently invert each vial several times, prior to each use, to ensure a homogeneous mixture
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability:

Opened
Reagents Un Opened
2-25°c
Up to Expiry Date
ISE Low Serum Standards (66317) 90 Days
on Vial
Up to Expiry Date
ISE High Serum Standards (66316) 90 Days
on Vial
Up to Expiry Date
ISE Low / High Urine Standard (66315) 90 Days
on Vial
Up to Expiry Date
ISE Na, K Selectivity Check (66313) **** Store at 15-25°c**** 90 Days
on Vial

NOTE: Reagents and standards should be allowed to equilibrate to room temperature prior to use.

CO2 / Bicarbonate Calibrator (ODC0019)

 Two Levels of 25 ml each – (Pack = 3 x 25ml + 3 x 25ml)
 The calibrators are ready for use.
 Mark OPEN date on vial and also write Expiry Date after opening based on the storage option.

Storage and Stability:

Un Opened Opened
Reagents
15 - 25°C 15 - 25°C
Up to Expiry Date
CO2 30 Days
on Vial

NOTE: Storage at Room Temperature

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Maintenance Solutions
 Reagents are ready to use.

Storage and Stability:

Opened
Reagent Un Opened
2-25°c
CLEANING SOLUTION (ODR20067)
Up to Expiry Date Up to Expiry Date
(For Contamination Avoidance)
on Vial on Vial
Pack: 4 x 54 mL (Loaded on Reagent Carousel position 74)

Storage and Stability:

Opened
Reagent Un Opened
2-8°c
ISE CLEANING SOLUTION (OE66039) Up to Expiry Date Up to Expiry Date
Pack: 6 x 500 ml on Vial on Vial

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