PHOSPHORUS UV FS* Targa BT 3000 - Grupo BioSys ... determination 1 + 20 with dist. water. Multiply...

Biosys Ltda 1 Rev 01 03/05/02

PHOSPHORUS UV FS*

Order information

Cat. No. Kit size

10 520 021 R 5 x 25 ml + 1 x 3 ml standard

Method

Photometric UV test

Phosphorus reacts with Ammonium Molybdate and Sulphuric Acid to form an inorganic Phosphorus Molybdate complex. The complex absorption is maximal in ultraviolet light at 340 nm.

Reagent preparation and stability

The reagent and standard are ready-to-use and stable up to the end of the

indicated month of expiry, if contamination is avoided and stored at 2 – 25

°C.

Specimen

Serum, heparinized plasma, urine.

For serum / plasma: Avoid hemolysis!

For collection of 24 h urine, please add 10 ml of 10 % HCl into the collection bottle to avoid phosphate precipitations. Dilute the specimen

before determination 1 + 20 with dist. water. Multiply the result by 21.

Components and concentration in the test Sulphuric acid pH 1.0 210 mmol/l Ammonium Molybdate 0.4 mmol/l

Detergents

Standard: 5 mg/dl (1.61 mmol/l)

Notes The reagent contains Sulphuric Acid. Carefully rinse skin and mucous

membranes with water after contact with the reagent.

Normal range (see reference 2,3) Adults: 2,7 - 4,5 mg/dl 0,87 - 1,45 mmol/l

Children up to 4 weeks: 4,8 - 9,6 mg/dl 1,56 - 3,10 mmol/l

up to 12 months: 4,8 - 7,9 mg/dl 1,56 - 2,54 mmol/l > 12 months: 3,4 - 6,2 mg/dl 1,09 - 2,00 mmol/l

24 h urine: 0,4 - 1,3 g/24 h 13 - 42 mmol/24 h

References 1. Daly, J. A., Ertingshausen, G., Clin. Chem., 18, (1972), 263

2. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis, 2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 218 3. Tietz, N. W.: Textbook of Clinical Chemistry, 2nd edition,

W. B. Saunders Company, Philadelphia 1994, 2202

* fluid stable

Targa BT 3000

INSTRUMENT PARAMETER

Test Typ End Point Single Serum Starter (Inactive) Filters (A/B) 340/700 Units mg/dl Test Method With Factor Test Methodology UV Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 15.0 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 300

Reaction Direction Increasing Reagent Dilution 1:1 Initial ABS (mABS) 0.000 Curve Acceptance 100% Automatic profile (Inactive) Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name PHOSPHORUS Sample Volume (l) 3

Dilution Ratio 1:1 Min. Max. M. 2.10/5.60 Min. Max. F. 1.50/6.80 Min. Max. B. 4.00/7.00

Urine Parameters Tests Name Urine Volume (l) 0

Min. Max. M. 0.000 / 0.000 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution 0 Multi Factor 1.00

October 1998/2

Targa BT 3000


Test Typ Kinetic With Starter

Serum Starter (Active) Filters (A/B) 340 Units UI/l Test Method With Factor Test Methodology IFCC Number of washes 1/1 Delay Time (Sec) 60 Inc. Time (Sec) 0/10 Reading Time (Sec) 60 Test Limit (Conc) 600 Reactio Limit (mABS) 700 Max ABS Delta (mABS) 300 Reagent mAbs Limit (mABS) 1400 Reagents A/B (l) 240/60

Reaction Direction Decreasing Reagent Dilution 1:1 Initial ABS (mABS) 2000 Curve Acceptance 100% Automatic profile (Inactive) Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name GPT Sample Volume (l) 30

Dilution Ratio 1:4 Min. Max. M. 0.000/42.0 Min. Max. F. 0.000 / 32.0 Min. Max. B. 0.000 / 0.000


Min. Max. M. 0.000 / 0.000 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution (Inactive) Multi Factor 1.00

Calculation Factor 1746

**Applications developed before December 2003 had been used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control

ALAT(GPT) FS (IFCC mod.)

Order information

Cat. No. 1 2701 .. .. …

Notes

1. Please refer to the package insert for ALAT(GPT) FS (IFCC

Mod.) for detailed information about the test on the following:

Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding

- Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison

Reference Ranges Literature

2. The stability of the reagent on board the analyser is at least

one month provided that contamination and evaporation are avoided.

3. Manufactured by

DiaSys Diagnostic Systems GmbH Alte Strasse 9, 65558 Holzheim, Germany

October 1998/2

Targa BT 3000


Test Typ End Point Single Serum Starter (Inactive) Filters (A/B) 578/700 Units g/l Test Method With Factor Test Methodology BCG Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 180 Reading Time (Sec) 10 Test Limit (Conc) 60.0 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 400 Reagents A/B (l) 300


Serum Parameters Tests Name ALBUMIN Sample Volume (l) 3

Dilution Ratio 1:2 Min. Max. M. 35/55 Min. Max. F. 0.000/0.000 Min. Max. B. 0.000/0.000




ALBUMIN FS

Order information

Cat. No. 1 0220 .. .. …

Notes

1. Please refer to the package insert for Albumin FS for

detailed information about the test on the following:




2. The stability of the reagent on board the analyser is 6

weeks provided that contamination and evaporation are avoided.

3. Manufactured by


October 1998/2

Targa BT 3000


Test Typ Kinetic with Starter

Serum Starter (Active) Filters (A/B) 405/700 Units UI/L Test Method with Factor Test Methodology IFCC Number of washes I/I Delay Time (Sec) 90 Inc. Time (Sec) 0/30 Reading Time (Sec) 60 Test Limit (Conc) 1000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 350 Reagent mAbs Limit (mABS) 800 Reagents A/B (l) 240/60

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 1200 Curve Acceptance 100% Automatic profile (In Active) Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name AP Sample Volume (l) 3

Dilution Ratio I:I Min. Max. M. 64/306 Min. Max. F. 0/0 Min. Max. B. 0/0

Urine Parameters Tests Name Urine Volume (l) I

Min. Max. M. 0/0 Min. Max. F. 0/0 Min. Max. B. 0/0 Auto Dilution (Inactive) Multi Factor 1.00

**Applications developed before December 2003 had been

used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control

ALKALINE PHOSPHATASE FS DGKC

Order information

Cat. No. 1 0401 .. .. …

Notes

1. Please refer to the package insert for

Alkaline phosphatase DGKC FS for detailed information about the test on the following:




2. The stability of the reagent on board the analyser is at least one

month provided that contamination and evaporation are avoided.

3. Manufactured by


October 1998/2

ALKALINE PHOSPHATASE IFCC FS*

Order information Cat. No. Kit size 10 041 021 R1 5 x 20 ml + R2 1 x 25 ml 10 041 022 R1 5 x 80 ml + R2 1 x 100 ml 10 041 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Kinetic, colorimetric test according to IFCC (International Federation of Clinical Chemistry)

In alkaline buffer AP convertes p-Nitrophenylphosphate into p-Nitrophenol and Phosphate. The increase in absorbance from p-Nitrophenol is directly proportional to the activity of the AP.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent 2 must be protected from light.

Specimen Serum, heparinized plasma. Avoid hemolysis! Loss of activity after 2 – 3 days at 15 – 25 °C < 10 %.

Components and concentration in the test R1: 2-Amino-2-methyl-1-propanol pH 10.4 0.35 mol/l Magnesium Sulphate 2.0 mmol/l Zinc Sulphate 1.0 mmol/l HEDTA 2.0 mmol/l R2: p-Nitrophenylphosphate 16.0 mmol/l

Notes 1. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes.

2. During the reaction p-Nitrophenol is produced. This is poisonous when inhaled, swallowed or when absorbed throught the skin. If the reaction mixture comes into contact with skin or mucous membranes wash copiously with water!

Normal range (see reference 2)

37 °C Men (20 – 50 years) 53 – 128 U/l Men (> 60 years) 56 – 119 U/l Women (20 – 50 years) 42 – 98 U/l Women (> 60 years) 53 – 141 U/l

References

1. Tietz, N. W., Rinker, A. D., Shaw, L. M., J. Clin. Chem. Clin. Biochem., 21, (1983), 731 – 748

2. Tietz, N. W., Textbook of Clinical Chemistry, 2nd

edition, W. B. Saunders Company, Philadelphia 1994, 2202

* fluid stable

Targa BT 3000



Serum Starter (Active) Filters (A/B) 405/700 Units UI/l Test Method With Factor Test Methodology IFCC Number of washes 1/1 Delay Time (Sec) 90 Inc. Time (Sec) 0/30 Reading Time (Sec) 60 Test Limit (Conc) 2000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 350 Reagent mAbs Limit (mABS) 800 Reagents A/B (l) 240/60

Reaction Direction Increasing Reagent Dilution 1:1 Initial ABS (mABS) 1200 Curve Acceptance 100% Automatic profile (Inactive) Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name AP Sample Volume (l) 3






October 1998/2

-AMYLASE CC* FS** Substrate EPS-G7 Order information Cat. No. Kit size 10 050 021 R1 5 x 20 ml + R2 1 x 25 ml 10 050 022 R1 5 x 80 ml + R2 1 x 100 ml 10 050 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Enzymatic color test with complete conversion of all PNP- Oligomaltosides produced by Amylase activity. The test results represent Total Amylase activity (all isoenzymes).

Substrate: 4,6-Ethyliden-(G7)-p-Nitrophenyl (G1)-- D-Maltoheptaoside (EPS-G7)

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and protected from light.

Specimen Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Stability: serum / plasma: min. 1 week at 2 – 25 °C urine: 2 days at 15 – 25 °C 10 days at 2 - 8 °C

Components and concentration in the test R1: GOOD’s buffer pH 7.1 100 mmol/l NaCl 50 mmol/l MgCl2 10 mmol/l Alpha-Glucosidase > 2 KU/l R2: GOOD’s buffer pH 7.1 100 mmol/l EPS-G7 1.6 mmol/l

Notes 1. For urine as sample material the sample volumes should be

divided in half. 2. Hemoglobin interferes.

3. Saliva and skin do contain -Amylase. Therefore never pipette by mouth and avoid skin contact with the reagents.

4. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

5. Conversion factor refers to previous PNP- G7 methods which utilised factors in order to correlate and keep the same normal range.


without conversion factor 37 °C

Serum / plasma up to 100 U/l Random urine up to 450 U/l 24 h urine up to 410 U/24 h with conversion factor 37 °C

Serum / plasma up to 220 U/l Random urine up to 1000 U/l 24 h urine up to 900 U/24 h

References

1. Hohenwallner, W., et al., J. Clin. Chem. Clin. Biochem., 27, (1989), 97 – 101

2. Kruse-Jarres, J. D., et al., J. Clin. Chem. Clin. Biochem., 27, (1989), 103

* complete color ** fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 405/700 Units UI/l Test Method With Factor Test Methodology EPS G7 Number of washes 1/1 Delay Time (Sec) 120 Inc. Time (Sec) 0/30 Reading Time (Sec) 60 Test Limit (Conc) 2000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 200 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60


Serum Parameters Tests Name -Amylase Sample Volume (l) 6

Dilution Ratio 1:1 Min. Max. M. 0.000/220 Min. Max. F. 0.000/0.000 Min. Max. B. 0.000 / 0.000



Calculation Factor with Conversion 11077 Calculation Factor without Conversion 5151


October 1998/2

Targa BT 3000


Test Typ End Point Double

Serum Starter In Active Filters (A/B) 578 Units mg/L Test Method with Factor Test Methodology Turbid Number of washes I Delay Time (Sec) 0 Inc. Time (Sec) 300/10 Reading Time (Sec) 300 Test Limit (Conc) 250 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 2500 Reagents A/B (l) 250/50

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 0 Curve Acceptance 100% Automatic profile In Active Rerun Test Rgt Blk H:M Pathological Repetition

Serum Parameters Tests Name Apo AI Sample Volume (l) 2

Dilution Ratio 1:5 Min. Max. M. 110/220 Min. Max. F. Min. Max. B.

Urine Parameters Tests Name Urine Volume (l)

Min. Max. M. Min. Max. F. Min. Max. B. Auto Dilution Multi Factor

APOLIPOPROTEIN A1 FS

Order information Cat. No. Kit size

10 710 021 R1 5 x 25 ml + R2 1 x 25 ml 1 7102 99 10 730 R1 4 x 20 ml + R2 2 x 8 ml 1 7102 99 10 735 R1 2 x 20 ml + R2 1 x 8 ml 1 7100 99 10 041 3 x 1 ml TruCal Apo A1/B Calibrator set with 3 different levels

Notes

1. Please refer to the package insert for Apoliporotein A1 FS for






month provided that contamination and evaporation are avoided. 3. Manufactured by



October 1998/2

Targa BT 3000



Serum Starter (Active) Filters (A/B) 340 Units UI/l Test Method With Factor Test Methodology IFCC Number of washes 1/1 Delay Time (Sec) 60 Inc. Time (Sec) 0/10 Reading Time (Sec) 60 Test Limit (Conc) 600 Reactio Limit (mABS) 700 Max ABS Delta (mABS) 300 Reagent mAbs Limit (mABS) 1400 Reagents A/B (l) 240/60


Serum Parameters Tests Name GOT Sample Volume (l) 30

Dilution Ratio 1:4 Min. Max. M. 0.000/37.0 Min. Max. F. 0.000/31.0 Min. Max. B. 0.000 / 0.000






ASAT(GOT) FS (IFCC mod.)

Order information

Cat. No. 1 2601 .. .. …

Notes

1. Please refer to the package insert for

ASAT(GOT) FS (IFCC Mod) for the detailed information about the test on the following:






3. Manufactured by


October 1998/2

Targa BT 3000


Test Typ Endpoint with Starter

Serum Starter (Inactive) Filters (A/B) 546/700 Units mg/dl Test Method With Factor Test Methodology DCA Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 120/300 Reading Time (Sec) 10 Test Limit (Conc) 8.0 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 150 Reagents A/B (l) 240/60


Serum Parameters Tests Name DIREKT

BILIRUBIN Sample Volume (l) 25





BILIRUBIN AUTO DIRECT FS

Order information

Cat. No. 1 0821 .. .. …

Notes

1. Please refer to the package insert for Bilirubin Auto Direct FS

for detailed information about the test on the following:






3. Manufactured by


October 1998/2

BILIRUBIN AUTO TOTAL FS* Order information Cat. No. Kit size 10 081 021 R1 5 x 20 ml + R2 1 x 25 ml 10 081 022 R1 5 x 80 ml + R2 1 x 100 ml 10 081 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Colorimetric test, “DCA (2,4-Dichloroaniline)“

Total Bilirubin in presence of diazotized 2,4-Dichloroaniline forms a red colored azocompound in acidic solution. A specific mixture of detergents enables a safe determination of the Total Bilirubin.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent 2 must be protected from light.

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Store protected from light. Stability: 1 day at 15 – 25 °C 4 days at 2 – 8 °C up to 3 months at - 20 °C (not in case of repeated deep freezing)

Components and concentration in the test R1: TRIS pH 8.2 8 mmol/l NaCl 7 g/l Detergents R2: 2,4-Dichlorophenyl Diazoniumsalt 1 mmol/l HCl 30 mmol/l Detergents

Notes Ascorbic acid and Hemoglobin interfere.

Normal range (see reference 2,3)

Newborn 0 - 24 h: up to 5 mg/dl ( 86 µmol/l) 24 - 48 h: up to 9 mg/dl ( 155 µmol/l) 3 – 5 days: up to 12 mg/dl ( 205 µmol/l) after 4 weeks: up to 1.5 mg/dl ( 26 µmol/l) Adults: up to 1.1 mg/dl (18.8 µmol/l)

References

1. Rand, R. N., di Pasqua, A., Clin Chem., 8, (1962), 570 2. Weigl, E., Bach, H., Krieg, D., Med. Klin., 70, (1975), 664 – 669 3. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 246 * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 546/700 Units mg/dl Test Method With Factor Test Methodology DCA Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 120/300 Reading Time (Sec) 10 Test Limit (Conc) 30.0 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 150 Reagents A/B (l) 240/60


Serum Parameters Tests Name TOTAL

BILIRUBIN

Sample Volume (l) 5






October 1998/2

CALCIUM AS FS*

Order information Cat. No. Kit size 1 1130 99 10 021 R 5 x 25 ml + 1 x 3 ml Standard 1 1130 99 10 026 R 6 x 100 ml 1 1130 99 10 023 R 1 x 1000 ml 1 1130 99 10 030 6 x 3 ml Standard

Method Photometric test using arsenazo III

Principle Calcium with Arsenazo III at neutral pH yields a blue colored complex, whose intensity is proportional to the calcium concentration. Interference by magnesium is eliminated by addition of 8-hydroyquinoline-5-sulfonic acid.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and contamination is avoided. Do not freeze the reagents!.

Specimen Serum or heparin plasma. For urine add 10 ml concentrated HCl to the 24 h urine and heat the specimen to dissolve calcium oxalate.

Stability in serum/plasma:

7 days at 20 – 25°C 3 weeks at 2 – 8°C 8 months at -20°C Stability in urine:

2 days at 20 – 25°C 4 days at 2 – 8°C 3 weeks at -20°C

Components and Concentration in the Test Reagent Reagent pH 7.50 Phosphate buffer 50 mmol/l 8-Hydoxyquinoline-5-sulfonic acid 5 mmol/l Arsenazo III 120 µmol/l Detergents

Standard: 10 mg/dl ( 2.5 mmol/l)

Notes 1. As calcium is an urbiquitary ion, essential precaution must be

taken against accidental contaminations. Only use disposable materials.

2. Traces of chelating agent, such as EDTA, can prevent the formation of the colored complex.

3. For detailed product information see detailed package insert.

Reference range

Serum/plasma 8.6 - 10.3 mg/dl (2.15 - 2.57 mmol/l) Urine <250 mg/24h (6.24 mmol/24h)

<300 mg/24h (7.49 mmol/24h)

Performance Characteristics Measuring Range The test has been developed to determine calcium concentrations within a measuring range from 0.04 – 25 mg/dl (0.01 – 6.25 mmol/l). When values exceed this range the samples should be diluted 1+1 with NaCl solution ( 9g/l) and the result multiplied by 2.

Sensitivity / Limit of detection The lower limit of detection is 0.04 mg/dl (0.01 mmol/l) . * fluid stable

Targa BT 3000


Test Typ End Point Single

Serum Starter (Inactive) Filters (A/B) 630/700 Units mg/dl Test Method With Factor Test Methodology ARSENAZO Number of washes 2 Delay Time (Sec) 0 Inc. Time (Sec) 240 Reading Time (Sec) 10 Test Limit (Conc) 30 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 400 Reagents A/B (l) 300


Serum Parameters Tests Name CALCIUM Sample Volume (l) 3



Min. Max. M. 50.0/400 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution 1:5 Multi Factor 1.00


January 2008/1

Targa BT 3000



Serum Starter (Active) Filters (A/B) 405 Units U/l Test Method With Factor Test Methodology BTC Number of washes 1/1 Delay Time (Sec) 120 Inc. Time (Sec) 0/120 Reading Time (Sec) 120 Test Limit (Conc) 20000 Reaction Limit (mABS) 100 Max ABS Delta (mABS) 900 Reagent mAbs Limit (mABS) 1000 Reagents A/B (l) 240/60


Serum Parameters Tests Name CHE Sample Volume (l) 5

Dilution Ratio 1:4 Min. Max. M. 4620/11500 Min. Max. F. 3930/10800 Min. Max. B. 0.000 / 0.000




**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution.

CHOLINESTERASE FS

Order information

Cat. No. 1 1401 .. .. …

Notes

1. Please refer to the package insert for Cholinesterase FS for





2. The stability of the reagent on board the analyser is 8

weeks provided that contamination and evaporation are avoided.

3. Manufactured by


October 1998/2

CHLORIDE FS*

Order information Cat. No. Kit size 10 120 021 R1 5 x 25 ml + 1 x 3 ml standard 10 120 022 R1 6 x 100 ml + 2 x 3 ml standard 10 120 023 R1 1 x 1000 ml 10 120 030 6 x 3 ml standard

Method Colorimetric test, ”Thiocyanate”

Chloride is releasing equivalent quantities of Thiocyanate from Mercury (II) Thiocyanate. Together with Iron ions Thiocyanate forms a red colored complex. The intensity of the color is proportional to the Chloride concentration.

Reagent preparation and stability The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 15 – 25 °C and protected from light. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen Serum, plasma. Avoid hemolysis!

Components and concentration in the test Mercury (II) Thiocyanate 2 mmol/l Mercury (II) Chloride 0.8 mmol/l Ferric (III) Nitrate 20 mmol/l Nitric acid 28 mmol/l Standard: 100 mEq/l (mmol/l)

Notes The reagent contains Mercury (II) Thiocyanate and Mercury (II) Chloride. Do not swallow! Avoid contact with skin and mucous membranes.


Adults: 98 - 110 mEq/l (98 - 110 mmol/l) Children: 95 - 112 mEq/l (95 - 112 mmol/l)

References

1. Schoenfeld, R. G., Lewellen, C. J., Clin. Chem., 10, (1964), 533 2. Witt, I., Trendelenburg, Chr., J. Clin. Chem. Clin. Biochem., 20,

(1982), 235 - 242 * fluid stable

Targa BT 3000


Test Typ Endpoint Single

Serum Starter (Inactive) Filters (A/B) 480/700 Units mmol/L Test Method with Factor Test Methodology Thio Number of washes I Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 130 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 1000 Reagents A/B (l) 300

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 0 Curve Acceptance 100% Automatic profile Inactive Rerun Test Rgt Blk H:M 00:00 Pathological Repetition Inactive

Serum Parameters Tests Name CHLORIDE Sample Volume (l) 3

Dilution Ratio I:I Min. Max. M. 98/107 Min. Max. F. 0/0 Min. Max. B. 0/0


Min. Max. M. Min. Max. F. Min. Max. B. Auto Dilution 0:2 Multi Factor 1.00


October 1998/2

CHOLESTEROL FS*

Order information Cat. No. Kit size 10 130 021 R1 5 x 25 ml + 1 x 3 ml standard 10 130 022 R1 6 x 100 ml + 2 x 3 ml standard 10 130 023 R1 1 x 1000 ml 10 130 030 6 x 3 ml standard

Method Enzymatic colorimetric test, “CHOD-PAP“

Determination of Cholesterol after enzymatic hydrolysis and oxidation. The colorimetric indicator is Chinonimine which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.

Reagent preparation and stability The reagent is ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 - 8 °C. The reagent must be protected from light. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen Serum, heparinized or EDTA plasma; Avoid hemolysis!

Components and concentration in the test GOOD's buffer pH 6.7 50 mmol/l Phenol 5 mmol/l 4-Aminoantipyrine 0.3 mmol/l Cholesterol Esterase > 200 U/l Cholesterol Oxidase > 50 U/l Peroxidase > 3 KU/l Standard: 200 mg/dl (5.2 mmol/l)

Notes

The reagent contains Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes.

Clinical interpretation (see reference 4)

Suspect: over 220 mg/dl (5.7 mmol/l) Elevated: over 260 mg/dl (6.7 mmol/l) As per recommendation of the European Consensus Conference it is recommendable to lower the Cholesterol level in blood of about 180 mg/dl for adults up to 30 years of age and to about 200 mg/dl for adults of over 30 years of age.

References

1. Richmond, W., Clin. Chem., 19, (1973), 1350 - 1356 2. Roeschlau, P., Bernt, E., Gruber, W., Z. Klin. Chem. Klin.

Biochem, 12, (1974), 403 - 407 3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 4. Schettler, G., Nüssel, E., Arbeitsmed. Sozialmed.

Präventivmed., 10, (1975), 25 * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology TRINDER Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 750 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 200 Reagents A/B (l) 300


Serum Parameters Tests Name CHOLESTERO

L Sample Volume (l) 3






October 1998/2

CK-MB FS*

Order information Cat. No. Kit size 10 165 021 R1 5 x 20 ml + R2 1 x 25 ml 10 165 022 R1 5 x 80 ml + R2 1 x 100 ml 10 165 023 R1 1 x 800 ml + R2 1 x 200 ml

Method Optimized UV test according to the recommendations of the DGKC (German Society of Clinical Chemistry) and IFCC (International Federation of Clinical Chemistry) for CK-NAC. The CK-MB consists of the subunits CK-M and CK-B. A specific antibody against CK-M inhibits the complete CK-MM activity (main part of the total CK activity) and the CK-M subunit of CK-MB. Only CK-B activity is measured, which is half of the CK-MB activity.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided, stored at 2 – 8 °C and protected from light.

Specimen Serum, heparinized or EDTA plasma. Avoid hemolysis! Loss of activity: at 2 – 8 °C after 24 h < 10 %

at 15 - 25 °C after 1 h < 10 %.

Components and concentration in the test R1 + R2 Imidazole pH 6.7 100 mmol/l Creatine Phosphate 30 mmol/l Glucose 20 mmol/l N-Acetyl Cysteine 20 mmol/l Magnesium Acetate 10 mmol/l EDTA 2 mmol/l ADP 2 mmol/l NADP 2 mmol/l AMP 5 mmol/l Diadenosine Pentaphosphate 10 µmol/l Glucose-6-phosphate Dehydrogenase > 1.5 KU/l Hexokinase > 2.5 KU/l CK-M (human) inhibiting polyclonal antibodies (sheep) inhibiting capacity > 2000 U/l

Notes 1. Hemoglobin interferes. 2. The reagents contain Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes.


The likelihood of a cardiac infarction is high under the following circumstances:

CK Women CK Men

37 °C > 167 U/l > 190 U/l

and

CK-MB 37 °C > 24 U/l

and

A CK-MB activity between 6 and 25 % of the Total CK activity

If a cardiac infarction is suspected but the above conditions are not fulfilled, a fresh infarction may have occured. The determination should then be repeated with a fresh sample after 4 hours.

References 1. Würzburg, U., et al., Klin. Wschr., 54, (1976), 357 – 360 2. Würzburg, U., et al.‚ J. Clin. Chem. Clin. Biochem., 15,

(1977), 131 3. Stein, W., Med. Welt., (1985), 572 - 577

* fluid stable

Targa BT 3000


Test Typ Kinetic with Starter

Serum Starter (Active) Filters (A/B) 340/700 Units UI/L Test Method with Factor Test Methodology UV Number of washes I Delay Time (Sec) 300 Inc. Time (Sec) 30 Reading Time (Sec) 240 Test Limit (Conc) 1000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 500 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60


Serum Parameters Tests Name CK-MB Sample Volume (l) 12

Dilution Ratio 1:10 Min. Max. M. 0/24 Min. Max. F. 0/0 Min. Max. B. 0/0




October 1998/2

Targa BT 3000



Serum Starter (Active) Filters (A/B) 340/700 Units UI/l Test Method With Factor Test Methodology U.V. Number of washes 1/1 Delay Time (Sec) 180 Inc. Time (Sec) 0/30 Reading Time (Sec) 90 Test Limit (Conc) 1000 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 300 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60


Serum Parameters Tests Name CREATINKINAS

E

Sample Volume (l) 10

Dilution Ratio 1:4 Min. Max. M. 0.00/190 Min. Max. F. 0.00/165 Min. Max. B. 0.000 / 0.000



CALCULATION FACTOR 4920


CK-NAC FS Order information

Cat. No. 1 1601 .. .. …

Notes

1. Please refer to the package insert for CK-NAC FS for







3. Manufactured by


October 1998/2

Targa BT 3000


Test Typ Fixed Time with Starter

Serum Starter (Active) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology Jaffe Number of washes 1/2 Delay Time (Sec) 60 Inc. Time (Sec) 0/10 Reading Time (Sec) 60 Test Limit (Conc) 15.0 Reactio Limit (mABS) 1500 Max ABS Delta (mABS) 150 Reagent mAbs Limit (mABS) 600 Reagents A/B (l) 240/60


Serum Parameters Tests Name Creatinine Sample Volume (l) 18



Min. Max. M. 0.000 / 0.000 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution 1:40 Multi Factor 1.00



CREATININE FS Order information

Cat. No. 1 1711 .. .. …

Notes

1. Please refer to the package insert for Creatinine FS for detailed

information about the test on the following:




2. The stability of the reagent on board the analyser 4 days

provided that contamination and evaporation are avoided.

3. Manufactured by


April 2004/2

Targa BT 3000


Test Type End Point Double

Serum Starter In Active Filters (A/B) 578/700 Units µg/l Test Method with Factor Test Methodology Turbid Number of washes I Delay Time (Sec) 30 Inc. Time (Sec) 100/100 Reading Time (Sec) 100 Test Limit (Conc) 1000 Reaction Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 2500 Reagents A/B (l) 200/100


Serum Parameters Tests Name Ferr Sample Volume (l) 10




FERRITIN FS Order information Cat. No. Kit size 1 7059 99 10 731 R1 3 x 20 ml + R2 3 x 10 ml 1 7059 99 10 735 R1 1 x 20 ml + R2 1 x 10 ml 1 7050 99 10 058 4 x 1 ml TruCal Ferritin: Calibrator set with 4 different levels

Notes 1. Please refer to the package insert for Ferritin FS for detailed

information about the test on the following Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics regarding - Measuring Range - Specificity/Interferences - Sensitivity/Limit of Detection - Precision (Reproducibility, Repeatability) - Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the analyser is at least one



**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

October 1998/2

Targa BT 3000



Serum Starter (Active) Filters (A/B) 405 Units UI/l Test Method With Factor Test Methodology SZAZS Number of washes 1/1 Delay Time (Sec) 60 Inc. Time (Sec) 0/60 Reading Time (Sec) 60 Test Limit (Conc) 800 Reactio Limit (mABS) 2500 Max ABS Delta (mABS) 900 Reagent mAbs Limit (mABS) 1500 Reagents A/B (l) 240/60


Serum Parameters Tests Name GGT Sample Volume (l) 30

Dilution Ratio 1:4 Min. Max. M. 11.0/50.0 Min. Max. F. 7.00/32.0 Min. Max. B. 0.000 / 0.000





GAMMA GT FS (Szasz mod.) Order information

Cat. No. 1 2801 .. .. …

Notes

1. Please refer to the package insert for Gamma-GT FS

(Szasz mod.) for detailed information about the test on the following:






3. Manufactured by


October 1998/2

Targa BT 3000


Test Typ Endpoint Single Serum Starter (Inactive) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology TRINDER Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 600 Reading Time (Sec) 10 Test Limit (Conc) 400 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 200 Reagents A/B (l) 300


Serum Parameters Tests Name GLUCOSE Sample Volume (l) 3





GLUCOSE GOD FS

Order information

Cat. No. 1 2500 .. .. …

Notes

1. Please refer to the package insert for Glucose GOD FS for







3. Manufactured by


October 1998/2

Targa BT 3000


Test Typ End point double

Serum Starter InActive Filters (A/B) 340/405 Units mg/dl Test Method with Factor Test Methodology UV Number of washes I Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 900 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 1200 Reagents A/B (l) 240/60


Serum Parameters Tests Name GLUCOSE Sample Volume (l) 3



Min. Max. M. Min. Max. F. Min. Max. B. Auto Dilution Multi Factor 1.00


GLUCOSE HEXOKINASE FS

Order information

Cat. No. 1 2511 .. .. …

Notes

1. Please refer to the package insert for Glucose Hexokinase FS

for detailed information about the test on the following:






3. Manufactured by


November 2009/2

Targa BT 3000


Test Typ Endpoint with starter

Serum Starter (Inactive) Filters (A/B) 630 Units # Test Method Cubic Spline Test Methodology DiaSys Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) # Reaction Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 1400 Reagents A/B (l) 300/150


Serum Parameters Tests Name HbA1c Sample Volume (l) 6




# User defined

HbA1c FS

Order information

Cat. No. 1 3329 .. .. …

Notes

1. Please refer to the package insert for oneHbA1c FS for detailed







3. Manufactured by


**This application proposal is for guidelines only. To avoid misinterpretation measured results have to be validated and assessed with caution

HDL-C IMMUNO FS*

Order information Cat. No. Kit size 1 3521 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml 1 3521 99 10 022 R1 5 x 80 ml + R2 1 x 100 ml 1 3521 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml 1 3520 99 10 065 3 x 3 ml calibrator

Method HDL-C Immuno is a homogeneous method without centrifugation step. Antigen – antibody complexes are formed with LDL,VLDL and Chylomicrons in a way that only HDL-C is selectively determined by an enzymatic measurement.

Reagent preparation and stability The reagents and the calibrator are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C.

On board stability: 4 weeks at 2 - 8 °C

Stability of calibrator after reconstitution*:

5 days 1 month

at at

2 - 8 °C - 20 °C

*The calibrator package insert has instructions on handling and reconstitution.

Specimen Serum, heparinized plasma. Avoid hemolysis!

Stability: 1 week at 2 - 8 °C 1 month at below - 20 °C 2 years at below - 70 °C

Components and concentration in the test R1: Good’s Buffer pH 7.0 30 mmol/l 4-Aminoantipyrine 0.54 mmol/l Peroxidase 1440 U/l Ascorbate Oxidase 1620 U/l Anti-human - lipoprotein antibody

R2: Good’s Buffer pH 7.0 30 mmol/l Cholesterol Esterase 800 U/l Cholesterol Oxidase 4000 U/l F-DAOS** 0.16 mmol/l Calibrator: as indicated on the label (approx. 50 mg/dl)

Notes The calibrator was only produced with human sera. The human serum used was tested and found negative for HBsAg, anti-HIV antibody and anti-HCV antibody. As a risk of infection cannot be completely excluded, the calibrators should be handled as carefully as patient samples.


Lipid metabolic disorder Cholesterol < 200 mg/dl (5.2 mmol/l) No Triglycerides < 200 mg/dl (2.3 mmol/l)

Cholesterol 200 - 300 mg/dl Yes, if HDL-Cholesterol (5.2 – 7.8 mmol/l) < 35 mg/dl ( 0.9 mmol/l)

Cholesterol > 300 mg/dl (7.8 mmol/l) Yes Triglycerides > 200 mg/dl (2.3 mmol/l)

As per recommendation of the European Consensus Conference it is recommendable to lower the Cholesterol level in blood to about 180 mg/dl for adults up to 30 years of age and to about 200 mg/dl for adults of over 30 years of age.

References 1. Friedewald, W. T., et al., Clin. Chem., 18, (1972), 499 2. Study Group, European Atherosclerosis Society, European Heart

Journal, 8, (1987), 77 – 88 3. Rifal, N., Warnick, G. R., Laboratory Measurement of Lipids,

Lipoproteins and Apolipoproteins. AACC Press. Washington DC, USA 1994

4. Burtis, C. A., Ashwood, E. R., Tietz, N. W.: Textbook of Clinical Chemistry, 2nd edition, W. B. Saunders Company, Philadelphia 1994

5. Gordon, T., Castelli, W. P., Hjortland, M. C., et al., Am. J. Med. 62, (1977), 707 - 714

* fluid stable ** F-DAOS = N-ethyl-N-(2-hydroxy-3-sulfopropyl)-3,5-dimethoxy- 4-fluoroaniline, sodium salt

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 578/700 Units mmol//l Test Method With Factor Test Methodology imuno Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 300/300 Reading Time (Sec) 10 Test Limit (Conc) 180 Reaction Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 150 Reagents A/B (l) 240/60


Serum Parameters Tests Name HDL

Sample Volume (l) 3





August 2000/2

Targa BT 3000


Test Type Endpoint with Starter

Serum Starter (Inactive) Filters (A/B) 578/700 Units g/dl Test Method With Factor Test Methodology Ferene Number of washes 1/3 Delay Time (Sec) 0 Inc. Time (Sec) 120/300 Reading Time (Sec) 10 Test Limit (Conc) 1000 Reaction Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 1500 Reagents A/B (l) 300/75


Serum Parameters Tests Name IRON Ferene Sample Volume (l) 18

Dilution Ratio 1:1 Min. Max. M. 35.0/168 Min. Max. F. 23.0/165 Min. Max. B. 0.000/0.000

Urine Parameters Tests Name URINE IRON Urine Volume (l) 0


CALIBRATOR

IRON FS Ferene Order information Cat. No. Kit size 1 1911 99 10 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3ml Std

1 1911 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

1 1911 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

10 190 030 6 x 3 ml Standard

Notes

1. Please refer to the package insert for Iron FS Ferene for







3. Manufactured by



September 2001/2

October 1998/2

Targa BT 3000



Serum Starter (Active) Filters (A/B) 340 Units UI/l Test Method With Factor Test Methodology DGKC Number of washes 1/1 Delay Time (Sec) 120 Inc. Time (Sec) 0/30 Reading Time (Sec) 90 Test Limit (Conc) 1200 Reactio Limit (mABS) 100 Max ABS Delta (mABS) 350 Reagent mAbs Limit (mABS) 1100 Reagents A/B (l) 240/60


Serum Parameters Tests Name LDH Sample Volume (l) 3

Dilution Ratio 1:4 Min. Max. M. 225/450 Min. Max. F. 225/450 Min. Max. B. 0.000 / 0.000






LDH FS DGKC

Order information

Cat. No. 1 4201 .. .. …

Notes

1. Please refer to the package insert for LDH DGKC FS for detailed







3. Manufactured by

DiaSys Diagnostic Systems Alte Strasse 9, 65558 Holzheim, Germany

September 2001/2

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 578/700 Units mg/dl Test Method With Factor Test Methodology LDL Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 300/300 Reading Time (Sec) 10 Test Limit (Conc) 400 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60


Serum Parameters Tests Name LDL

Sample Volume (l) 3




LDL-C SELECT FS

Order information Cat. No. Kit size

1 4121 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml

1 4121 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

1 4121 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

1 3520 99 10 065 3 x 3 ml Calibrator

Notes

1. Please refer to the package insert for LDL-C Select FS for the

detailed information about the test on the following: Clinical Relevance Method and Principle Composition and Stability of the Reagents Specimens Calibrators and Controls Performance Characteristics concerning; Measuring Range Specificity/Interferences Sensitivity/Limit of Detection

Precision (Reproducibility, Repeatability) Method Comparison Reference Ranges Literature 2. The stability of the reagent on board the analyser is at least one

month provided that contamination and evaporation are avoided. 3. Manufactured by DiaSys Diagnostic Systems GmbH Alte

Strasse 9, 65558 Holzheim, Germany. **Applications developed before December 2003 had been used at a variety of customer laboratories and are validated by use. Software upgrades at specific analysers may require further adjustments as they are out of our control

June 2003/2

Targa BT 3000



Serum Starter Active Filters (A/B) 578 Units U/l Test Method with Factor Test Methodology Kin Number of washes I Delay Time (Sec) 180 Inc. Time (Sec) 0/30 Reading Time (Sec) 90 Test Limit (Conc) 300 Reaction Limit (mABS) 2500 Max ABS Delta (mABS) 300 Reagent mAbs Limit (mABS) 500 Reagents A/B (l) 240/60

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 1000 Curve Acceptance 100% Automatic profile In Active Rerun Test Rgt Blk H:M 00:00 Pathological Repetition (Inactive)

Serum Parameters Tests Name Lipase Sample Volume (l) 5




LIPASE DC FS

Order information Cat. No. Kit size 1 4321 99 10 021 R1 5 x 20 ml + R2 1 x 25 ml

1 4321 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml

1 4321 99 10 023 R1 1 x 800 ml + R2 1 x 200 ml

Notes

1. Please refer to the package insert for Lipase DC FS for detailed









Targa BT 3000


Test Typ End Point Double

Serum Starter In Active Filters (A/B) 340 Units mg/L Test Method with Factor Test Methodology Turbid Number of washes I Delay Time (Sec) 0 Inc. Time (Sec) 300/10 Reading Time (Sec) 300 Test Limit (Conc) 150 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 2500 Reagents A/B (l) 250/50


Serum Parameters Tests Name LPA Sample Volume (l) 7




Lp(a) FS Order information Cat. No. Kit size 1 7122 99 10 015 R1 2 x 25 ml + R2 1 x 10 ml

10 712 021 R1 5 x 25 ml + R2 1 x 25 ml 1 7122 99 10 730 R1 4 x 20 ml + R2 2 x 8 ml

1 7120 99 10 041 3 x 1 ml TruCal Lp(a) Calibrator set with 3 different levels

Notes

1. Please refer to the package insert for Lp(a) FS for detailed








November 1999/2

MAGNESIUM XL FS*

Order information

Cat. No. Kit size 1 4610 99 10 021 R 5 x 25 ml + 1 x 3 ml standard 1 4610 99 10 026 R 6 x 100 ml 1 4610 99 10 023 R 1 x 1000 ml 1 4610 99 10 030 6 x 3 ml standard

Method Photometric test using xylidyl blue.

Principle Magnesium ions form a purple colored complex with xylidyl blue in alkaline solution. In presence of GEDTA, which complexes calcium ions, the reaction is specific. The intensity of the purple color is proportional to the magnesium concentration.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Do not freeze the reagents!

Specimen

Serum, plasma, cerebrospinal fluid (CSF) and urine. Do not use EDTA plasma. Acidify urine with some drops of conc. HCl to pH 3 – 4 and then dilute 1 + 4 with dist. water. Multiply the result by 5.

Stability in serum/plasma:

7 days at 20 – 25°C 7 days at 2 – 8°C 1 year at -20°C

Stability in urine:

3 days at 20 – 25°C 3 days at 2 – 8°C 1 year at -20°C

Components and Concentration in the Test

Reagent Reagent pH 11.0 Ethanolamine 1 mol/l GEDTA 60 µmoll Xylidyl blue 110 µmol/l Detergents Standard: 2 mg/dl (0.82 mmol/l)

Notes 1. Hemoglobin interferes. 2. For detailed product information see package insert

Reference range

Serum / plasma Neonates 1.2 – 2.6 mg/dl (0.48 – 1.05 mmol/l) Children 1.5 – 2.3 mg/dl (0.60 – 0.95 mmol/l) Women 1.9 – 2.5 mg/dl (0.77 – 1.03 mmol/l) Men 1.8 – 2.6 mg/dl (0.73 – 1.06 mmol/l) Urine 73 – 122 mg/24 h (3 – 5 mmol/24 h CSF 2.1 – 3.3 mg/dl (0.85 – 1.35 mmol/l)

Performance Characteristics

Measuring Range The test has been developed to determine magnesium concentrations within a measuring range from 0.05 – 5 mg/dl (0.02 – 2.05 mmol/l). When values exceed this range samples should be diluted 1+4 with NaCl solution ( 9g/l) and the result multiplied by 5.

Sensitivity / Limit of detection The lower limit of detection is 0.05 mg/dl (0.02 mmol/l) fluid stable

Targa BT 3000



Serum Starter In Active Filters (A/B) 546 Units mmol/L Test Method with Factor Test Methodology Xylidyl Blue Number of washes 2 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 2.05 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 1000 Reagents A/B (l) 300

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 0 Curve Acceptance 100% Automatic profile In Active Rerun Test Rgt Blk H:M 00:00 Pathological Repetition In Active

Serum Parameters Tests Name Magnesium Sample Volume (l) 3

Dilution Ratio 1:2 Min. Max. M. 1.9/2.5 Min. Max. F. Min. Max. B.

Urine Parameters Tests Name Urine MG Urine Volume (l) 3

Min. Max. M. 2.0/6.2 Min. Max. F. Min. Max. B. Auto Dilution Multi Factor


October 1998/2

TOTAL PROTEIN IN URINE FS* Order information Cat. No. Kit size 1 0210 99 10 021 R 5 x 25 ml + 1 x 3 ml standard 1 0210 99 10 026 R 6 x 100 ml 1 0210 99 10 023 R 1 x 1000 ml 1 0210 99 10 030 6 x 3 ml standard

Method Colorimetric test, “Pyrogallol Red“

Proteins together with Pyrogallol Red / Molybdate form a red complex. The color is directly proportional to the protein concentration.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent must be protected from light.

Specimen Urine, cerebro-spinal fluid

Components and concentration in the test Pyrogallol Red 50 µmol/l Sodium Molybdate 40 µmol/l Detergents Standard: 0.2 g/l (200 mg/l)


Urine 40 – 80 mg/24 h Cerebro-spinal fluid (liquor) up to 500 mg/l * *This value is only to be taken as a guide line. Reference values are declared for liquor / serum quotients on the general package insert. Liquor / serum quotients for albumin:

30th week of pregnancy < 50 x 10

-3

Birth < 25 x 10-3

1 month < 15 x 10-3

6 months < 5 x 10-3

20 years < 5 x 10-3

40 years < 7 x 10-3

60 years < 8 x 10-3

These values are approximately equal to the liquor / serum quotient of Total Protein. For exact calculation refer to the following table:

Q (Albumin) Q (Total Protein) 7 x 10

-3 8 x 10

-3

10 x 10-3

11 x 10-3

20 x 10

-3 18 x 10

-3

50 x 10-3

40 x 10-3

References 1. Fujita, Y., Mori, I., Kitano, S., Bunseki Kakagu, 32, (1983), 379

– 386 2. Orsonneau, J.-L., Douet, P., Massoubre, C., Lustenberger, P.,

Bernard, S., Clin. Chem., 35, (1989), 2233 3. Watanabe, N., Kamei, S., Ohkubo, A., Yamanaka, M., Ohsawa,

S., Makino, K., Tokuda, K., Clin Chem., 32, (1986), 1551 4. Guder, W. G., Hofmann, W., Weber, M. H.: Kleinkonferenz

“Proteinurie“, DG Klinische Chemie Mitteil., 22, (1991), 78 5. Thomas, L.: Labor und Diagnose, 4

th edition, Die Medizinische

Verlagsgesellschaft, Marburg 1992, 1716

* fluid stable

Targa BT 3000


Test Typ End Point Single Serum Starter (Inactive) Filters (A/B) 578/700 Units mg/l Test Method With Factor Test Methodology PR Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 3000 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 400 Reagents A/B (l) 300


Serum Parameters Tests Name TPU Sample Volume (l) 3

Dilution Ratio 1:2 Min. Max. M. / Min. Max. F. 0.000/0.000 Min. Max. B. 0.000/0.000


Min. Max. M. 24 / 141 Min. Max. F. 0.000 / 0.000 Min. Max. B. 0.000 / 0.000 Auto Dilution (Inactive) Multi Factor 1.00



October 1998/2

TOTAL PROTEIN FS* Order information Cat. No. Kit size 10 231 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std 1 2311 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 231 023 R1 1 x 800 ml + R2 1 x 200 ml 10 230 030 6 x 3 ml standard

Method Colorimetric test, “Biuret“

Proteins together with Copper ions form a violet blue complex in alkaline solution. The absorbance of the color is directly proportional to the concentration.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 25 °C. Stability of standard: until expiry date, when stored at 2 – 8 °C

Specimen

Serum or plasma. Avoid hemolysis!

Components and concentration in the test

R1: Sodium Hydroxide 80 mmol/l Potassium Sodium Tartrate 12.8 mmol/l R2: Sodium Hydroxide 100 mmol/l Potassium Sodium Tartrate 16 mmol/l Potassium Iodide 15 mmol/l Copper Sulphate 6 mmol/l Standard: 5 g/dl

Notes

1. Serum or plasma from patients who have received large intravenous amounts of Polydextrans yields values which are too high with the Biuret method. In such cases the protein concentration should be determined by an alternative method (e. g. Kjeldahl).

2. The reagents contain Sodium Hydroxide. Do not swallow! If the reagents come in contact with skin of mucous membranes rinse immediately with water!


Adults: 6,2 – 8,4 g/dl Children 1 day – 4 weeks: 4,52 – 6,86 g/dl 2 – 12 months: 4,57 – 7,33 g/dl > 12 months: 5,85 – 8,01 g/dl

References

1. Henry, R. J., Sobel, C., Berkmann, S., Anal. Chem., 29, (1957), 1491

2. Peters, T., Clin. Chem., 14, (1968), 1147 3. Keller, H.: Klinisch-chemische Labordiagnostik für die Praxis,

2nd

edition, Georg Thieme Verlag, Stuttgart 1991, 263 * fluid stable

Targa BT 3000



Serum Starter In Active Filters (A/B) 546/700 Units g/L Test Method with Factor Test Methodology Biuret Number of washes I Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 150 Reactio Limit (mABS) 0 Max ABS Delta (mABS) 0 Reagent mAbs Limit (mABS) 300 Reagents A/B (l) 240/60

Reaction Direction Increasing Reagent Dilution I:I Initial ABS (mABS) 0 Curve Acceptance 100% Automatic profile In Active Rerun Test Rgt Blk H:M 00:00 Pathological Repetition In Active

Serum Parameters Tests Name Total Protein Sample Volume (l) 6






October 1998/2

TRIGLYCERIDES FS* Order information Cat. No. Kit size 10 571 021 R1 5 x 25 ml + 1 x 3 ml standard 10 571 022 R1 6 x 100 ml + 2 x 3 ml standard 10 571 023 R1 1 x 1000 ml 10 570 030 6 x 3 ml standard

Method Colorimetric enzymatic test, “GPO“

Determination of Triglycerides after enzymatic splitting with Lipoprotein Lipase. Indicator is Chinonimine, which is generated from 4-Aminoantipyrine and Phenol by Hydrogen Peroxide under the catalytic action of Peroxidase.

Reagent preparation and stability The reagent and standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagent must be protected from light.

Specimen

Serum, heparinized or EDTA plasma. Avoid hemolysis!


GOOD‘ s buffer pH 7.2 50 mmol/l 4-Chlorophenol 4 mmol/l

Mg2+ 15 mmol/l

ATP 2 mmol/l Glycerokinase > 0.4 KU/l Peroxidase > 2 KU/l Lipoprotein Lipase > 2 KU/l 4-Aminoantipyrine 0.5 mmol/l Glycerol-3- phosphate Oxidase > 0.5 KU/l Standard: 200 mg/dl (2.3 mmol/l)

Notes

1. To correct for free Glycerol, subtract 10 mg/dl (0.11 mmol/l) from the Triglycerides result.

2. Ascorbic acid interferes. 3. The reagent contains Sodium Azide (0.095 %) as preservative.

Do not swallow! Avoid contact with skin and mucous membranes !


Suspect over: 150 mg/dl (1.71 mmol/l) Increased over: 200 mg/dl (2.28 mmol/l)

References

1. Schettler, G., Nüssel, E., Arbeitsmedizin Sozialmedizin Präventivmedizin, 10, (1975), 25

2. Jacobs, N. J., Vandemark, P. J., Arch. Biochem. Biophys., 88, (1960), 250 – 255

3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 4. Koditschek, L. K., Umbreit, W. W., Journ. of Bacteriol., 98,

(1969), 1063 - 1068 * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology TRINDER Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 1000 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 200 Reagents A/B (l) 300


Serum Parameters Tests Name TRIGLYCERID

E Sample Volume (l) 3

Dilution Ratio 1:4 Min. Max. M. 60.0/150 Min. Max. F. 0.000/0.000 Min. Max. B. 0.000/0.000



CALIBRATOR:



Targa BT 3000


Test Type Endpoint with Starter

Serum Starter (Inactive) Filters (A/B) 578/700 Units g/dl Test Method With Factor Test Methodology Ferene Number of washes 1/3 Delay Time (Sec) 0 Inc. Time (Sec) 120/300 Reading Time (Sec) 10 Test Limit (Conc) 750 Reaction Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 1500 Reagents A/B (l) 300/75


Serum Parameters Tests Name UIBC Sample Volume (l) 20

Dilution Ratio 1:1 Min. Max. M. 120/470 Min. Max. F. 120/470 Min. Max. B. 0.000/0.000

Urine Parameters Tests Name UIBC Urine Volume (l) 0


CALIBRATOR

UIBC FS

Order information

Cat. No. 1 1921 .. .. …

Notes

1. Please refer to the package insert for UIBC FS for detailed





2. The stability of the reagent on board the analyser is 6 days

provided that contamination and evaporation are avoided.

3. Manufactured by


**This application proposal is for guidelines only. To avoid

misinterpretation measured results have to be validated and assessed with caution.

January 2007/2

October 1998/2

UREA FS*

Order information

Cat. No. Kit size 10 310 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3101 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 310 023 R1 1 x 800 ml + R2 1 x 200 ml 10 310 030 6 x 3 ml standard

Method Enzymatic UV test, “Urease - GLDH“

Urease acts on Urea to produce Ammonium and Carbonate ions. Glutamic Dehydrogenase catalyzes the oxidation of Ammonium ions with 2-Oxoglutarate and NADH under formation of Glutamate. The decrease of NADH is proportional to the Urea concentration.

Reagent preparation and stability The reagents are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. Stability of standard: until expiry date, when stored at 2 – 25 °C

Specimen

Serum, plasma (no Ammonium Heparin), fresh urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 100 with dist. water Stability in serum / plasma: 1 week at 2 – 8 °C 2 days at 15 – 25 °C

Components and concentration in the test R1: Tris buffer pH 7.8 120 mmol/l 2-Oxoglutarate 7 mmol/l ADP 0.6 mmol/l Urease > 6 KU/l GLDH > 1 KU/l R2: NADH 0.25 mmol/l Standard: 50 mg/dl (8.33 mmol/l)

Notes

1. The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes!

2. To convert Urea into BUN multiply by 0.47; to convert BUN into Urea multiply by 2.14.


Serum / plasma: 10 - 50 mg/dl (1.7 - 8.3 mmol/l) Urine: 20 - 35 g/24 h (333 - 583 mmol/24 h)

References

1. Talke, H., Schubert, G. E., Klin. Wschr., 43, (1965), 174 2. MacKay, E. M., MacKay, L. L., J. Clin. Invest., 4, (1927), 295 3. Sarre, H.: Nierenkrankheiten, Georg Thieme Verlag,

Stuttgart 1959 * fluid stable

Targa BT 3000


Test Typ Fixed Time with Starter

Serum Starter (Active) Filters (A/B) 340/700 Units mg/dl Test Method With Factor Test Methodology U.V. Number of washes 1/1 Delay Time (Sec) 30 Inc. Time (Sec) 0/10 Reading Time (Sec) 60 Test Limit (Conc) 300 Reactio Limit (mABS) 400 Max ABS Delta (mABS) 500 Reagent mAbs Limit (mABS) 1400 Reagents A/B (l) 240/60


Serum Parameters Tests Name UREA Sample Volume (l) 3


Urine Parameters Tests Name URINE UREA Urine Volume (l) 3


CALIBRATOR:



October 1998/2

URIC ACID FS* TOOS

Order information

Cat. No. Kit size 10 300 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3001 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 300 023 R1 1 x 800 ml + R2 1 x 200 ml 10 300 030 6 x 3 ml standard

Method Enzymatic colorimetric test, “TOOS“

Uric acid is oxidized to Allantoine by Uricase. The generated Hydrogen Peroxide reacts with 4-Aminoantipyrine and N-Ethyl- N-(2-hydroxy-3-sulfopropyl)-m-toluidin (TOOS) to a blue violet dye.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagents must be protected from light.

Specimen

Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 10 with dist. water.


R1: Phosphate buffer pH 7.0 100 mmol/l TOOS 1 mmol/l Ascorbate Oxidase > 1 KU/l R2: Phosphate buffer pH 7.0 100 mmol/l 4-Aminoantipyrine 0,3 mmol/l Potassiumhexacyanoferrate (II) 10 µmol/l POD > 1 KU/l Uricase > 50 U/l Standard: 6 mg/dl (357 µmol/l)

Notes The reagents contain Sodium Azide (0.095 %) as preservative. Do not swallow! Avoid contact with skin and mucous membranes!


Serum: Men: 3.4 - 7.0 mg/dl 200 – 420 µmol/l Women: 2.4 - 5.7 mg/dl 140 – 340 µmol/l Urine: 250 - 750 mg/24 h 1.5 - 4.5 mmol/24 h

References

1. Barham, D., Trinder, P., Analyst, 97, (1972), 142 – 145 2. Thefeld, W., Hoffmeister, H., Busch, E.-W., Koller, P. U.,

Vollmar, J., Dtsch. Med. Wschr., 98, (1973), 380 – 384 3. Henry, R. J., Cannon, D. C., Winkelmann, J.: Clinical Chemistry,

Principles and Technics, 2nd

edition, Harper & Row Publishers Inc., Hagerstown Maryland 1974, 534

4. Fossati, P., Prencipe, L., Berti, G., Clin. Chem., 26, (1980), 227 – 231

* fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 546700 Units mg/dl Test Method With Factor Test Methodology TOOS Number of washes 1/1 Delay Time (Sec) 0 Inc. Time (Sec) 300/300 Reading Time (Sec) 10 Test Limit (Conc) 20 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 100 Reagents A/B (l) 240/60


Serum Parameters Tests Name URIC ACID Sample Volume (l) 6




CALIBRATOR:



Octber 1998/2

URIC ACID FS*

TBHBA

Order information Cat. No. Kit size 10 302 021 R1 4 x 20 ml + R2 1 x 20 ml + 1 x 3 ml std. 1 3021 99 10 026 R1 5 x 80 ml + R2 1 x 100 ml 10 302 023 R1 1 x 800ml + R2 1 x 200 ml 10 300 030 6 x 3 ml standard

Method Enzymatic colorimetric test, “TBHBA“

Uric acid is oxidized to Allantoine by Uricase. The generated Hydrogen Peroxide reacts with 4-Aminoantipyrine and 2,4,6-Tribromo-3-hydroxybenzoic acid (TBHBA) to Chinonimine.

Reagent preparation and stability The reagents and the standard are ready-to-use and stable up to the end of the indicated month of expiry, if contamination is avoided and stored at 2 – 8 °C. The reagents must be protected from light.

Specimen

Serum, heparinized or EDTA plasma, urine. For serum / plasma: Avoid hemolysis! Dilute urine 1 + 10 with distilled water.


R1: Phosphate buffer pH 7.0 100 mmol/l TBHBA (2,4,6-Tribromo-3-Hydroxy-

benzoic acid) 1 mmol/l

R2: Phosphate buffer pH 7.0 100 mmol/l 4-Aminoantipyrine 0,3 mmol/l Potassiumhexacyanoferrate (II) 10 µmol/l POD > 2 KU/l Uricase > 30 U/l Standard: 6 mg/dl (357 µmol/l)

Notes

Ascorbic acid interferes.


Serum: Men: 3.4 - 7.0 mg/dl (200 - 420 µmol/l) Women: 2.4 - 5.7 mg/dl (140 - 340 µmol/l) Urine: 250 - 750 mg/24 h (1.5 - 4.5 mmol/24 h)

References

1. Thefeld, W., Hoffmeister, H., Busch, E.-W., Koller, P. U., Vollmar, J., Dtsch. Med. Wschr., 98, (1973), 380 – 384

2. Henry, R. J., Cannon, D. C., Winkelmann, J.: Clinical Chemistry, Principles and Technics, 2

nd edition, Harper & Row Publishers

Inc., Hagerstown Maryland 1974, 534 3. Trinder, P., Ann. Clin. Biochem., 6, (1969), 24 - 27 4. Town, M.-H., Gehm, S., Hammer, B., Ziegenhorn, J.,

J. Clin. Chem. Clin. Biochem., 23, (1985), 591 * fluid stable

Targa BT 3000



Serum Starter (Inactive) Filters (A/B) 510/700 Units mg/dl Test Method With Factor Test Methodology TBHBA Number of washes 1 Delay Time (Sec) 0 Inc. Time (Sec) 300 Reading Time (Sec) 10 Test Limit (Conc) 20 Reactio Limit (mABS) 0.000 Max ABS Delta (mABS) 0.000 Reagent mAbs Limit (mABS) 300 Reagents A/B (l) 300


Serum Parameters Tests Name URIC ACID Sample Volume (l) 6




CALIBRATOR:



PHOSPHORUS UV FS* Targa BT 3000 - Grupo BioSys ... determination 1 + 20 with dist. water. Multiply...

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