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ABL800 FLEX Reference Manual

5. Performance characteristics

5. Performance characteristics

Overview

Introduction

This chapter describes performance characteristics for each measured parameter
and test conditions to obtain them.

Contents

This chapter contains the following topics.

Definition of terms and test conditions ............................................................

5-2

Performance test results – chart description.....................................................

5-5

Performance test results - pH ...........................................................................

5-8

Performance test results –

...................................................................... 5-10

Performance test results –

........................................................................ 5-13

Performance test results –

......................................................................... 5-16

Performance test results –

....................................................................... 5-18

Performance test results –

–

......................................................................... 5-20

Performance test results –

...................................................................... 5-26

Performance test results –

Glu........................................................................ 5-24

Performance test results –

Lac........................................................................ 5-26

Performance test results –

tHb........................................................................ 5-28

Performance test results - oximetry.................................................................. 5-30

Performance test results - bilirubin .................................................................. 5-40

Additional information about FLEXMODE .................................................... 5-46

Interference tests .............................................................................................. 5-47

References ........................................................................................................ 5-55

5-1

Summary of Contents for ABL800 FLEX

Page 1: ...uring principles 2 Amperometric measuring principles 3 Optical measuring principles 4 User defined corrections 5 Performance specifications 6 Parameters 7 Solutions and gas mixtures Index Date of Issu...

Page 2: ...void electrical hazards TRADEMARKS ABL Deep Picture QUALICHECK and Radiometer are trademarks of Radiometer Medical ApS Denmark ABL is registered in the USA QUALICHECK is registered in the USA and in s...

Page 3: ...ors for oximetry parameters and bilirubin 4 4 Electrolyte and metabolite parameters 4 7 5 Performance characteristics 5 1 Overview 5 1 Definition of terms and test conditions 5 2 Performance test resu...

Page 4: ...parameters 6 5 Input parameters 6 14 Derived parameters 6 17 Units and numerical format of derived parameters 6 22 List of equations 6 27 Oxyhemoglobin dissociation curve ODC 6 43 Conversion of units...

Page 5: ...NING CAUTION notices that appear in this manual are listed here in alphabetical order List of WARNING CAUTION Notices NOTES are not presented in list form S5370 Cleaning Additive Very toxic by inhalat...

Page 6: ...easuring principles and the pH pCO2 and electrolyte electrodes that are based on this principle Introduction Contents This chapter contains the following topics General information 1 2 Reference elect...

Page 7: ...olution both electrodes have separate potentials The membrane junctions between the sample and electrolyte solutions also have separate potentials The potentiometric measuring principle is applied to...

Page 8: ...the measurement conditions for ideal systems 1 cx the concentration of species mmol L NOTE To be exact activity is related to the molality of species x i e the number of mmoles per kg of solvent Howe...

Page 9: ...c to the electrode The calibration line forms the basis of the scale used by the analyzer to convert electrode chain potentials to concentrations Each electrode has a different calibration line The pH...

Page 10: ...ibed by the status and sensitivity Sensitivity The electrode sensitivity illustrates the slope of the calibration line compared to the slope of the theoretical electrode The sensitivity of the theoret...

Page 11: ...alue describes this deviation Status of the actual pH electrode at pH 7 400 is calculated as 100 5 61 400 7 400 7 400 7 at electr l theoretica of Potential at potential Meas Status Each electrode has...

Page 12: ...pCO2 electrode The Chemical Reference Laboratory at Radiometer is responsible for the accuracy of the calibrating solutions Traceability certificates for the individual solutions are enclosed in Chap...

Page 13: ...d Ag wire and the sample The solution is 4 M sodium formate HCOONa adjusted to pH 5 5 with hydrochloric acid The chloride concentration in the electrolyte solution is adjusted in accordance with the c...

Page 14: ...re pH is unequal on both sides The number of positive and negative ions is no longer equal so the potential difference across the membrane changes If the H concentrations on either side of the membran...

Page 15: ...equation pH Cal1 pH Cal2 61 5 Cal1 E pH Cal2 E pH Sens pH fraction The sensitivity of the pH electrode should fall between 0 92 1 03 or 92 103 Status The status of the pH electrode is calculated from...

Page 16: ...nt dependent cut off Equation A When an additional correction is needed equation A is first used together with the constants for the FLEXMODE 195 and 165 L no message mode Then the obtained results ar...

Page 17: ...DE message 872 1 0209 0 1575 A FLEXMODE message 871 1 025 0 1880 A FLEXMODE message 870 1 030 0 216 A FLEXMODE message 869 1 030 0 216 A 05 S165 0 9964 0 0150 A S95 0 9964 0 0150 A S85 0 9964 0 0150 A...

Page 18: ...must be met to obtain a stable electrode response during measurement pH limit i upd pH sample last upd pH sample where pH sample upd last pH value from the last updating with a measurement on calibrat...

Page 19: ...s through it Charged ions such as H will not pass Consequently dissolved CO2 from the sample will diffuse into the thin layer of bicarbonate electrolyte until the equilibrium is reached This produces...

Page 20: ...onic acid Ka the bicarbonate concentration and the solubility coefficient CO2 2 3 CO HCO H c c Ka is the equilibrium constant for carbonic acid pCO2 of the sample is then calculated from the equation...

Page 21: ...O CO 2 2 Gas 1 2 H O kPa Gas Gas 1 1 p F B p CO CO 2 2 Gas 2 2 H O kPa Gas Gas 2 2 The relative sensitivity of the pCO2 electrode is calculated as follows Sens CO E CO Gas2 E CO Gas1 Sens CO theo log...

Page 22: ...CO sample upd30 CO sample upd18 2 2 2 2 2 2 p p p p p p 2 2 For 1 33 kPa pCO2 sample pCO2 sample upd30 For 1 33 kPa 2 66 kPa p p CO sample predict CO sample upd30 2 2 133 2 66 133 For 2 66 kPa pCO2 sa...

Page 23: ...55 0 003573 1 1126 0 0051 0 0000002 1 12 0 28 A B FM no message 0 003573 1 1126 0 0051 0 0000002 A B FM message 874 0 003573 1 1126 0 0051 0 0000002 1 013 0 010 A B FM message 873 0 003573 1 1126 0 00...

Page 24: ...B FM message 872 0 003573 1 1126 0 0051 0 0000002 1 0884 0 1619 A B FM message 871 0 003573 1 1126 0 0051 0 0000002 1 090 0 150 A B 00 FM FLEXMODE The pCO2 measured from the sample is then corrected f...

Page 25: ...for at least one of the updating numbers pCO2 limit value for the stability criterion is 0 40 kPa 3 0 mmHg The following stability criteria must be met to obtain a stable electrode response during mea...

Page 26: ...expired air sample is accepted if the following criterion is fulfilled pCO2 sample upd 30 pCO2 sample upd 24 0 40 kPa 3 0 mmHg or pCO2 sample upd 30 pCO2 sample upd 24 0 04 pCO2 sample upd 30 Error m...

Page 27: ...ivity in the electrolyte and the sample If the cK in both solutions is the same the potential across the electrode tip will be 0 V The Na electrode E755 is an ion selective electrode whose sensing ele...

Page 28: ...solutions is the same the potential across the electrode tip will be 0 V The Cl electrode E744 is an ion selective electrode whose sensing element is a PVC membrane containing a chloride ion carrier T...

Page 29: ...Unknown dependent on sample composition ESample Ag AgCl electrode inner buffer solution Electrolyte electrode Known and constant when the Ag AgCl wire is immersed in the electrolyte solution EE Total...

Page 30: ...lectrode chain from a calibrration on Cal 2 solution 61 5 Theoretical sensitivity of the K and Na electrodes at 37 o C 30 75 Theoretical sensitivity of the Ca electrode at 37 o C 61 5 Theoretical sens...

Page 31: ...E Ca Cal1 E Ca Cal2 30 log Ca Cal1 Ca Cal2 fraction 2 2 75 c c Cl electrode Sens Cl E Cl Cal1 E Cl Cal2 61 5 log Cl Cal1 Cl Cal2 fraction c c The sensitivity limits of the electrolyte electrodes are...

Page 32: ...mmol L Drift Drift equations are given below K electrode Cal1 K prev Cal1 K 10 1 K Drift prev Sens K 61 5 prev Cal1 E K Cal1 E K c c mmol L Cal2 K prev Cal1 K 10 2 K Drift prev Sens K 61 5 prev Cal1 E...

Page 33: ...es Drift 2 Tolerances K 0 2 mmol L 1 5 mmol L Na 3 mmol L 1 mmol L Ca 0 05 mmol L 0 2 mmol L Cl 2 mmol L 3 mmol L Measurement The electrolyte concentration in a sample is calculated from the following...

Page 34: ...mple corr corrected value of the electrolyte ion in the sample A0 instrument dependent correction factor A1 instrument dependent correction cut off Chloride is corrected for interference The default v...

Page 35: ...B C95 1 03 1 09 A B FM no message 0 995 3 00 A FM message 874 1 030 1 00 A B FM FLEXMODE Corrections for cK ABL8XX FLEX Mode A0 A1 Equation 35 25 15 S195 0 985 0 065 A S95 1 05 0 13 A B C95 1 11 0 37...

Page 36: ...essage 874 1 08 0 04 A B 05 S165 1 004 0 022 A S95 1 05 0 004 A B C95 1 08 0 04 A B FM no message 1 004 0 022 A FM message 874 1 08 0 04 A B FM FLEXMODE Corrections for cCl ABL8XX FLEX Mode A0 A1 Equa...

Page 37: ...the updating numbers 18 or 19 K Constant for the stability criterion Electrolyte Ion Cal1 solution Cal2 solution K 0 01 0 01 Na 0 01 0 02 Ca2 0 02 0 02 Cl 0 022 0 022 The following stability criterio...

Page 38: ...te electrodes Continued Stability criteria continued K Constant for the stability criterion it equals to K 0 012 Na 0 012 Ca2 0 022 Cl 0 012 cXRinse Constant used indicates the concentration of the el...

Page 39: ...1 Potentiometric measuring principles ABL800 FLEX Reference Manual References Linnet N pH measurements in theory and practice 1st ed Copenhagen Radiometer Medical A S 1970 List of references 1 34...

Page 40: ...er describes the amperometric measuring principles and the pO2 and metabolite electrodes that are based on this principle Introduction Contents This chapter contains the following topics General infor...

Page 41: ...ve electrode where a reduction reaction occurs and electrons are consumed Anode Positive electrode where an oxidation reaction occurs and electrons are released Electrolyte solution Provides electrica...

Page 42: ...ion of A in the sample The amperometric measuring principle is applied in the pO2 glucose and lactate electrodes Calibration The electrodes are active elements and must be calibrated regularly as the...

Page 43: ...partially reduced according to the following equation O2 2H 2e H2O2 Electrode jacket AgCl reference band Membrane Electrolyte Electrode contact In the presence of Pt black H2O2 produced by the incompl...

Page 44: ...easurement on Gas 1 I O2 gas2 Current recorded at the pO2 electrode from a measurement on Gas 2 pO2 gas1 Partial pressure of O2 in Gas 1 pO2 gas2 Partial pressure of O2 in Gas 2 FO2 gas1 Fraction of O...

Page 45: ...ng chamber When the measurement on Gas 2 begins a relatively high current is recorded due to residual O2 from the rinse solution in the measuring chamber This current falls exponentially with time whi...

Page 46: ...pd sample O upd 30 sample O upd 6 sample O predict 2 2 2 2 2 2 2 p p p p p p where I O2 sample updi Current recorded at the pO2 electrode from updating number i with a measurement on the sample I O2 g...

Page 47: ...le O 2 1 2 2 B e k k p p p k3 and d1 e0 pO2 sample v1 e1 k1 correction constant 0 02614 k2 correction constant 0 02107 k3 correction constant 0 00281 e0 e1 e2 e3 e4 correction constants B barometric p...

Page 48: ...1199 4 7210 1 0156 4 2974 1 1035 A 30 20 S85 2 30300 5 96942 0 83281 6 07310 1 30565 A 10 C55 2 1199 4 7210 1 0156 4 2974 1 1035 A FM no message 2 30300 5 96942 0 83281 6 07310 1 30565 A FM message 87...

Page 49: ...sure of saturated water vapour 6 2571 kPa ABL800FLEX Mode A0 A1 Equation All Expired air 1 016 0 004 A When measuring on gas samples the constant K1 describes the gas liquid relationship for the elect...

Page 50: ...kPa if the following criteria are fulfilled then no result is reported 0 1 upd 6 sample O upd 18 sample O upd 18 sample O upd 30 sample O 2 2 2 2 p p p p or 6 0 upd 6 sample O upd 18 sample O upd 18...

Page 51: ...chain and the current through the chain is measured by an ampere meter Glucose or lactate molecules are transported across the outer membrane of the multi layer membrane The enzyme glucose oxidase or...

Page 52: ...d current measured at the electrode when no glucose or lactate is present in a solution As the rinse solution contains no glucose or lactate a baseline representing the zero current I0 as a function o...

Page 53: ...A1 Empirical constant dependent on electrode and determined from tests against the reference method tfinal Time of the last measurement updating on the calibration solution or sample tmean The mean ti...

Page 54: ...of Calibration Extrapolated base line N measurements of I0 on rinse solution End of Calibration I Cal 1 upd 2 I Cal 1 I Cal 1 upd 1 I Cal 1 upd N Electrode updatings The current at the metabolite elec...

Page 55: ...ctate 150 2000 pA mM Drift The drift in the sensitivity of the metabolite electrodes is calculated from the following equations 1 X Cal Sens final I final 1 I Cal Drift 0 c where I Cal 1 final Current...

Page 56: ...tions Equation A L 195 1 L 195 0 L 195 X sample A corr X sample A c c and Equation B cX sample corr micromode A0 micromode cX sample corr 195 L A1 mocromode where cX sample uncorrected measured metabo...

Page 57: ...M message 874 1 06 0 0 A B FM message 873 1 06 0 0 A B 05 S165 0 94 0 1 A S95 1 00 0 0 A B C95 1 06 0 0 A B C35 1 16 0 0 A B FM no message 0 94 0 1 A FM message 874 1 06 0 0 A B FM message 873 1 06 0...

Page 58: ...btain a stable electrode response during calibration I Cal 1 upd 30 I Cal 1 upd 21 9 Islope 0 Sd zero Sd max 50 upd 21 1 I Cal upd 11 1 I Cal upd 11 1 I Cal upd 1 1 I Cal log 5 9 All of the three crit...

Page 59: ...nt updatings around the regression line Sd max If Sens 400 pA mM then Sd max 0 025 Sens otherwise Sd max 10 0 The glucose or lactate in the sample is cX sample corr If the corrected concentration of t...

Page 60: ...rence error 1 upd 9 I sample upd 16 I sample upd 23 I sample upd 30 I sample I sample upd 16 I sample upd 12 I sample upd 12 I sample upd 9 cX sample corr 1 5 mmol L where I sample upd 30 I sample upd...

Page 61: ...ction This chapter describes the optical system its construction and the measuring method used Contents This chapter contains the following topics Optical system 3 2 Correcting for interferences 3 7 M...

Page 62: ...conjugated bilirubin in plasma NOTE ctBil can be measured on a whole blood or plasma sample Plasma samples provide the optimal measurement performance To obtain optimal accuracy when following a patie...

Page 63: ...e atmosphere is maintained throughout hemolyzation and measurement 3 Light from a 4 Watt halogen lamp is sent to the cuvette via an infra red filter and a biconvex lens The voltage across the halogen...

Page 64: ...intensity transmitted through water to the light intensity transmitted through the compound A I I log 0 where I0 intensity of light transmitted through water I0 is measured as the intensity of light...

Page 65: ...xygenated hemoglobin obtained by adding the spectra of O2Hb and HHb The additivity of absorption and the continuity of the spectra can clearly be seen 480 500 520 540 560 580 600 620 640 660 680 O2Hb...

Page 66: ...tribution and thereby the concentration of each compound in the sample The concentrations are determined using the following equation c A n n n y y total 1 128 K where Ky n a constant specific to comp...

Page 67: ...ccounted for in measurements on samples containing HbF e g from premature neonates and neonates aged 0 to 3 months then a deviation in the measurement will arise The deviation is most important for me...

Page 68: ...ays depending on the substance Either the substance is taken account of in the calculation of the matrix of constants K see the section Measuring Principle in this chapter This applies to Intralipids...

Page 69: ...HbF tHb where cO2Hb concentration of oxyhemoglobin in the sample cCOHb concentration of carboxyhemoglobin in the sample cHHb concentration of deoxyhemoglobin in the sample cMetHb concentration of met...

Page 70: ...ion has not been activated If ctHb 5 mmol L cO2HbF should be more than 1 mmol L If ctHb 5 mmol L cO2HbF ctHb should be more than 0 2 HbF correction has been activated No lower limit value for cO2HbF i...

Page 71: ...tant determined at tHb calibrations and automatically stored by the analyzer Fdil Analyzer dependent constant determined during tests against the reference method which corrects for Hb dilution in the...

Page 72: ...XMODE The uncorrected total bilirubin concentration ctBil sample measured on capillary or syringe samples is corrected as follows Corrections for ctBil Equation A dil cuv F F e tBil sampl corr e tBil...

Page 73: ...X Mode Fdil Equation 35 S195 1 0050 A S95 0 9320 A S85 1 0000 A C95 0 9320 A C55 0 8640 A C35oxi 0 9160 A FM no message 0 9900 A FM message 874 FM message 873 FM message 872 FM message 871 FM message...

Page 74: ...5th ed McGraw Hill 1985 2 Martens H Multivariate calibration quantitative interpretation of non selective chemical data Dr Techn Thesis NTH Univ of Trondheim 1986 3 Krzeminski A Why correct for fetal...

Page 75: ...ibes the basis of the user defined corrections available for all the measured parameters Contents This chapter contains the following topics General information 4 2 Correction factors for oximetry par...

Page 76: ...defined corrections are based on a linear correlation between the measured values without user defined corrections and the displayed values with user defined corrections The correction factors for eac...

Page 77: ...values are marked with a after the result Entering user defined corrections NOTE The user defined corrections will be applied to measurements on QC solution unless the Apply parameter corrections to...

Page 78: ...nd bilirubin on the ABL800 FLEX analyzers should be made without any entered corrections To avoid truncation errors from an enabled Out of range suppression function it is important to disable the fun...

Page 79: ...00 and ctHb is set to 15 g dL 9 3 mmol L and pH 7 4 Offset 0 050 The following recommendations apply to FHbF FHbF Item Description Units Fraction Sample Radiometer recommends that ctHb in the adult sa...

Page 80: ...gives an optimized accuracy of the correction Averaging repeated measurements on samples from the same donor also improves the accuracy Commercial bilirubin standards can interfere with bilirubin mea...

Page 81: ...lculated The user may for example make a linear correlation between the values measured on the ABL800 FLEX and the reference analyzers using the ABL800 FLEX as an independent variable If the measureme...

Page 82: ...ctrolyte and metabolite parameters Continued Resetting corrections to default values The Radiometer default values for the electrolyte and metabolite parameters must be reset manually by the user to 1...

Page 83: ...results chart description 5 5 Performance test results pH 5 8 Performance test results pCO2 5 10 Performance test results pO2 5 13 Performance test results cK 5 16 Performance test results cNa 5 18 Pe...

Page 84: ...e measured value on a group of test instruments and the estimated true value as assayed by the reference method BiasRef is determined as follows BiasRef XABL800 FLEX XPrimary Reference method BiasABL...

Page 85: ...Series of analyzers Parameter Description S0 Repeatability This is a standard deviation obtained from repeated measurements within a short interval of time using The same instrument and location The s...

Page 86: ...DE C95 C85 C55 C35 OXI C35 MET Blood samples Heparinized blood samples from healthy voluntary donors 11 Blood pools were prepared to cover test ranges for all measured parameters Blood measurements Th...

Page 87: ...chart is given below Chart Description x axis The ABL735 mean values obtained as follows To determine the best possible ABL735 reference value for each parameter of a specific sample the measurements...

Page 88: ...ot against the regression line at 5 ABL735 The individual measurements are plotted directly Chart Description x axis The ABL735 mean values obtained as follows To determine the best possible ABL735 re...

Page 89: ...he number of measurements in macro and micromodes and the total number of measurements during the test is listed below Parameter Nmacro Nmicro Total pH 3334 421 3755 pCO2 2768 397 3165 pO2 282 2912 31...

Page 90: ...ion saturated with KCl BMS Mk2 1 2 The calibration standards are traceable to the Primary Reference Standards for pH BiasREF The FLEXMODE on the ABL805 30 35 analyzers was tested pH Bias REF N 7 0 0 0...

Page 91: ...haracteristics Performance test results pH Continued Repeatability Repeatability is presented by the following chart Repeatability pH ABL800 FLEX Total variation Total variation is presented by the fo...

Page 92: ...le to NIST certified Standard Reference Materials BiasREF The FLEXMODE on the ABL805 30 35 analyzers was tested pCO2 mmHg Bias REF N 15 0 11 60 40 0 38 60 60 0 29 60 80 0 20 60 150 0 21 60 N number of...

Page 93: ...Performance test results pCO2 Continued Repeatability Repeatability is presented by the following chart Repeatability ABL800 FLEX mmHg Total variation Total variation is presented by the following cha...

Page 94: ...air samples pCO2 mmHg Bias ABL835 30 25 20 15 10 05 15 0 2 40 0 2 60 0 4 80 0 2 150 1 6 pCO2 mmHg S0 SD SABL SX 15 0 25 0 35 0 59 0 73 40 0 40 0 30 0 43 0 66 60 0 50 0 35 0 79 1 00 80 0 70 0 40 1 10...

Page 95: ...e to NIST certified Standard Reference Materials BiasREF The FLEXMODE on the ABL805 30 35 analyzers was tested pO2 mmHg Bias REF N 15 0 47 60 50 0 24 60 150 0 45 60 250 2 17 60 530 1 01 60 N number of...

Page 96: ...al Performance test results pO2 Continued Repeatability Repeatability is presented by the following chart Repeatability ABL835 mmHg Total variation Total variation is presented by the following chart...

Page 97: ...red air samples are as follows pO2 mmHg Bias ABL835 30 25 20 15 10 05 15 0 8 40 0 4 130 0 4 230 0 9 570 4 2 Imprecision pO2 mmHg S0 SD SABL SX 15 0 3 0 3 1 2 1 3 40 0 3 0 3 1 0 1 1 130 0 3 0 3 0 7 0 8...

Page 98: ...ference Material SRM 909b human serum BiasREF The FLEXMODE on the ABL805 35 analyzers was tested using SRM 909b cK mmol L Bias REF N 3 424 0 03 20 6 278 0 23 20 N number of measurements on several ana...

Page 99: ...cteristics Performance test results cK Continued Repeatability Repeatability is presented by the following chart Repeatability ABL800 FLEX mmol L Total variation Total variation is presented by the fo...

Page 100: ...d serum material specified using flame photometry BiasREF The FLEXMODE on the ABL805 35 analyzers was tested cNa mmol L Bias REF N 120 76 0 25 20 138 5 0 28 30 N number of measurements on several anal...

Page 101: ...teristics Performance test results cNa Continued Repeatability Repeatability is presented by the following chart Repeatability ABL800 FLEX mmol L Total variation Total variation is presented by the fo...

Page 102: ...ference Material SRM 909b human serum BiasREF The FLEXMODE on the ABL805 35 analyzers was tested using SRM 909b cCl mmol L Bias REF N 89 11 0 6 20 119 43 2 4 20 N number of measurements on several ana...

Page 103: ...teristics Performance test results cCl Continued Repeatability Repeatability is presented by the following chart Repeatability ABL800 FLEX mmol L Total variation Total variation is presented by the fo...

Page 104: ...ol per kg of water and pH 7 40 at 37 C using 1 mmol L 37 C HEPES buffer The standards were produced as indicated in 4 BiasREF The FLEXMODE on the ABL805 35 analyzers was tested cCa2 mmol L BiasREF N 0...

Page 105: ...teristics Performance test results cCa2 Continued Repeatability Repeatability is presented by the following chart Repeatability ABL800 FLEX mmol L Total variation Total variation is presented by the f...

Page 106: ...thod recommended by NCCLS 5 measured on serum BiasREF The FLEXMODE on the ABL805 35 analyzers was tested cGlu mmol L BiasREF N 0 08 0 03 30 2 09 0 06 30 5 08 0 12 30 14 73 0 02 30 N number of measurem...

Page 107: ...teristics Performance test results cGlu Continued Repeatability Repeatability is presented by the following chart Repeatability ABL800 FLEX mmol L Total variation Total variation is presented by the f...

Page 108: ...drogenase LDH method measured on serum 10 BiasREF The FLEXMODE on the ABL805 35 analyzers was tested cLac mmol L BiasREF N 0 36 0 08 30 2 06 0 12 30 8 3 0 81 30 11 3 0 62 30 N number of measurements o...

Page 109: ...teristics Performance test results cLac Continued Repeatability Repeatability is presented by the following chart Repeatability ABL800 FLEX mmol L Total variation Total variation is presented by the f...

Page 110: ...ded by NCCLS 6 BiasREF The FLEXMODE on the ABL830 35 analyzers was tested ctHb mmol L BiasREF N 15 SAT0 0 32 145 7 SAT100 0 04 145 15 SAT100 0 37 145 25 SAT100 0 97 145 N number of measurements on sev...

Page 111: ...teristics Performance test results ctHb Continued Repeatability Repeatability is presented by the following chart Repeatability ABL800 FLEX mmol L Total variation Total variation is presented by the f...

Page 112: ...ed for the oximetry parameters on the ABL520 analyzers are those presented below Parameter Primary reference method sO2 Tonometry whole blood is tonometered with a gas mixture containing 94 4 O2 and 5...

Page 113: ...sured directly against the reference built in the analyzer and these parameters are independent of the reference method Reduced verification 6 10 new analyzers are used over at least 1 day for selecte...

Page 114: ...7 100 0 10 0 10 0 25 0 30 15 100 0 05 0 10 0 25 0 30 25 100 0 05 0 10 0 30 0 35 sO2 micromodes Bias sO2 ABL835 25 15 ABL830 20 10 ctHb g dL sO2 S95 C95 S85 C55 C35 FM C55 C35 15 0 0 04 0 02 0 02 0 03...

Page 115: ...ion ctHb g dL FO2Hb S0 SD SABL SX 15 0 0 05 0 05 0 25 0 30 7 100 0 25 0 20 0 50 0 60 15 100 0 15 0 15 0 45 0 50 25 100 0 10 0 10 0 40 0 45 FO2Hb micromodes Bias FO2Hb ABL835 25 ctHb g dL FO2Hb S95 C95...

Page 116: ...dL sO2 FCOHb S195 FM S85 15 100 0 0 03 0 08 0 12 7 100 20 N A 0 47 N A 15 100 20 N A 0 10 N A 25 100 20 N A 0 47 N A FM FLEXMODE no message Imprecision ctHb g dL sO2 FCOHb S0 SD SABL SX 15 100 0 0 05...

Page 117: ...M FLEXMODE no message Imprecision ctHb g dL sO2 FCOHb S0 SD SABL SX 15 100 0 0 05 0 10 0 35 0 40 7 100 20 0 10 0 10 0 75 0 80 15 100 20 0 05 0 10 0 70 0 75 25 100 20 0 05 0 10 0 70 0 75 FMetHb macromo...

Page 118: ...A N A N A N A FMetHb ABL830 20 ctHb g dL sO2 FMetHb FM C55 C35 15 100 0 0 13 0 16 0 14 7 100 20 N A N A N A 15 100 20 N A N A N A 25 100 20 N A N A N A FM FLEXMODE no message Imprecision ctHb g dL sO...

Page 119: ...A N A 0 15 0 10 N A N A 0 10 FM FLEXMODE no message Imprecision ctHb g dL FHHb S0 SD SABL SX 15 0 0 05 0 10 0 30 0 35 FHbF adult blood Bias macromodes FHbF ABL835 ABL830 FHbF ctHb g dL S195 FM S85 0 1...

Page 120: ...5 5 5 5 5 2 0 0 5 6 5 6 5 6 5 6 5 6 5 6 5 6 5 6 FM FLEXMODE no message Imprecision micromodes ctHb g dL FHbF sO2 S0 SD SABL SX 10 4 4 5 8 15 2 3 5 7 20 0 100 2 2 10 11 NOTES a b FHbF fetal blood Bias...

Page 121: ...recision Specifications from S7770 The following corrections should be geometrically added to SInst and SX for the analyzer s wavelength calibrated with the S7770 Parameter Mode Level Correction perce...

Page 122: ...n whole blood the conclusion being that the ABL735 30 has satisfactory performance and can substitute other bilirubin measuring methods For adult use Adult samples within reference range The uncertain...

Page 123: ...9977 5 2 18 313 6 B adult 59 0 924 1 4 0 9981 3 8 2 366 7 F 52 45 a 0 904 0 942 5 6 2 6 0 9932 0 9941 12 0 5 3 4 635 4 300 8 A 46 1 075 9 6 0 9661 10 7 18 258 9 B 100 1 057 1 6 0 9819 12 0 3 297 10 D...

Page 124: ...0 200 250 300 350 0 50 100 150 200 250 300 Hitachi NIST ABL735 Syx 12 0 Actual field test from a neonatal critical care hospital using whole blood Values are in mol L The same data as above but depict...

Page 125: ...luding S0 SD and SABL The above field test regression statistics Syx include variations from S0 SD and ST Performance test results for bilirubin Macromodes 195 L and 85 L from syringe and capillary ct...

Page 126: ...0 15 100 7 9 6 7 13 5 12 5 19 7 22 3 400 20 100 9 5 10 9 17 8 23 6 30 7 33 9 Notes a b c NOTES a Adult fetal blood pH 7 4 0 1 normal MCHC and albumin variation Spiked with unconjugated bilirubin b ctB...

Page 127: ...uracy of analytical systems for clinical chemistry Eur J CLin Chem Clin Biochem 1992 30 311 17 4 Westgard JO Seehafer JJ Barry PL Allowable imprecision for laboratory test based on clinical and analyt...

Page 128: ...lume and parameter profile is included in the performance test results bias repeatability and imprecision given in this chapter Special tests with emphasis on extreme scenarios were conducted The foll...

Page 129: ...interference on pH measurements Electrolytes The following interference results are found for the electrolyte electrodes Interference on Substance Test Conc cK 4 mmol L level cNa 150 mmol L level cCa...

Page 130: ...following interference results are found for the metabolite electrodes Interference on Substance Test Conc mmol L cGlucose 4 0 mmol L level cLactate 1 5 mmol L level Acetoacetic acid 2 0 1 0 1 Acetyls...

Page 131: ...0 1 0 1 Lactic acid 12 0 1 Maltose 5 up to 0 4 Mannose 1 up to 0 4 Oxalate 90 0 47 0 14 Paracetamol 4 acetamidophenol 2 0 1 0 1 Pyruvate 2 0 1 0 1 Salicylic acid 4 0 1 0 1 Thiocyanic acid 24 Interfer...

Page 132: ...14 0 07 0 93 0 29 5 20 Evans Blue c 5 mg L 0 04 0 14 0 28 0 20 0 20 0 14 5 5 Betacarotene in plasma c 3 7 mol L 0 0 0 02 0 03 0 01 0 04 0 02 0 1 0 2 Patent Blue V c 10 mg L 0 16 0 39 0 86 0 47 0 00 0...

Page 133: ...fetal is the calculated fetal imprecision Sadult is the corresponding adult imprecision SHbF is the extra contribution from HbF correction which is listed in the following tables HbF correction contri...

Page 134: ...ocrit Hct which is used in the ctBil measurement MCHC is an average Hb concentration in the red blood cell RBC If the RBC volume decreases MCHC increases If a RBC has iron deficit MCHC decreases ctBil...

Page 135: ...rls Newborn 1 month 3 months 6 months 9 months 1 year 2 years 4 years 8 years 14 years 0 58 0 49 0 44 0 44 0 43 0 43 0 43 0 43 0 40 0 40 0 51 0 65 0 42 0 56 0 39 0 51 0 39 0 50 0 37 0 50 0 37 0 49 0 3...

Page 136: ...ue of pH 7 4 ctBil sensitivity for pH changes The following table shows the changes in ctBil compared to the value at pH 7 4 Sample Type ctHb g dL Nominal ctBil mol L ctBil 7 4 7 1 mol L ctBil 7 4 7 9...

Page 137: ...ucose NCCLS Publication RS1 A Villanova Pa NCCLS 1989 6 Reference and selected procedures for the quantitative determination of hemoglobin in blood Approved Standard 3rd edition NCCLS Publication H15...

Page 138: ...contains the following topics General information 6 2 Measured parameters 6 5 Input parameters 6 14 Derived parameters 6 17 Units and numerical format of derived parameters 6 22 List of equations 6 27...

Page 139: ...tains sufficient oxygen The oxygen concentration of arterial blood ctO2 a also termed oxygen content is determined by the concentration of total hemoglobin ctHb a the fraction of oxygenated hemoglobin...

Page 140: ...sured and derived parameters Reference Reference ranges are valuable guidelines for the clinician but they should not be regarded as absolute indicators of health and disease Reference ranges should b...

Page 141: ...his is because the actual values of the missing parameter may deviate significantly from the default value thus making the estimation clinically inappropriate If sO2 cannot be measured due to severe e...

Page 142: ...erwise specified pH Definition Indicates the acidity or alkalinity of the sample Unit Measuring range 6 300 8 000 Reference range 7 35 7 45 m f cH Definition Concentration of hydrogen ions in blood Un...

Page 143: ...ension of oxygen in blood High and low pO2 values of arterial blood indicate blood hyperoxia and hypoxia respectively Unit mmHg kPa torr Measuring range mmHg torr 0 0 800 kPa 0 00 107 Reference range...

Page 144: ...0 f g L 135 175 m 120 160 f mmol L 8 4 10 9 m 7 4 9 9 f Conversion of units ctHb g dL 1 61140 ctHb mmol L ctHb g L 16 1140 ctHb mmol L ctHb mmol L 0 62058 ctHb g dL 0 062058 ctHb g L Default value 9...

Page 145: ...as described in equation for Oxyhemoglobin Dissociation Curve points I and III s F F F F O S 1 MetHb COHb 1 COHb MetHb 2 where S ODC P A T P p F s F F pO O COHb O COHb MetHb 2 2 2 1 A a T 37 0 o C FO...

Page 146: ...action of methemoglobin in total hemoglobin in blood Unit fraction Measuring range 0 0 100 0 Fraction 0 000 1 000 Reference range 0 0 1 5 m f Fraction 0 00 0 015 m f Default value 0 004 0 4 FHHb Can a...

Page 147: ...in in total hemoglobin in blood Unit fraction Measuring range 0 100 Fraction 0 00 1 00 Reference range neonates 80 m f Fraction 0 80 m f cK Definition Concentration of potassium ions in plasma Unit mm...

Page 148: ...ium In Siggaard Andersen O ed Proceedings of the IFCC expert panel on pH and blood gases held at Herlev Hospital 1980 Copenhagen Radiometer Medical A S 1981 163 90 Available as AS79 cCl Definition Con...

Page 149: ...Lactate mmol L 0 11101 cLactate mg dL conversion based on the molecular weight of lactic acid ctBil Definition Concentration of total bilirubin in plasma Total bilirubin includes its two forms conjuga...

Page 150: ...03 205 mol L 1 0 8 0 mg dL 10 80 mg L 24 hrs full term 34 103 mol L 2 0 6 0 mg dL 20 60 mg L 48 hrs premature 103 205 mol L 6 12 mg dL 60 120 mg L 48 hrs 103 171 mol L 6 10 mg dL 60 100 mg L 3 5 days...

Page 151: ...o C T T C 32 9 5 o F T FO2 I Definition Fraction of oxygen in dry inspired air Unit fraction Input range 0 100 fraction 0 000 1 000 Reference range 35 5 44 7 m f ctHb Is used in the ABL800 05 FLEX Def...

Page 152: ...000 Q t Definition Cardiac output volume of blood delivered from the left ventricle into the aorta per unit of time Also termed CO or C O Input range Unit 0 0 1000 0 L min V O2 Definition Oxygen cons...

Page 153: ...p50 st may however vary due to variations in 2 3 DPG concentration or to the presence of abnormal hemoglobins Input range Unit mmHg torr 0 01 100 00 kPa 0 001 13 332 Conversion p kPa 0 133322 p mmHg...

Page 154: ...the actual oxygen saturation 4 5 Positive values base excess indicate a relative deficit of noncarbonic acids negative values base deficit indicate a relative excess of non carbonic acids dv 5 cBase B...

Page 155: ...st therefore reflects the metabolic status of the blood plasma dv 12 VCO2 V dry air The volume fraction of carbon dioxide in dry air dv 51 Oximetry derived parameters Symbol Definition Type Eq FHHb Fr...

Page 156: ...turation 50 in blood High and low values indicate decreased and increased affinity of oxygen to hemoglobin respectively dv 19 p50 T Partial pressure or tension of oxygen at half saturation 50 in blood...

Page 157: ...ntration of blood Also termed O2 content dv 27 ctO2 a v Oxygen concentration difference between arterial and mixed venous blood dv 28 BO2 Hemoglobin oxygen capacity the maximum concentration of oxygen...

Page 158: ...34 FShunt T FShunt at patient temperature dv 35 RI Respiratory Index ratio between the oxygen tension difference of alveolar air and arterial blood and the oxygen tension of arterial blood dv 36 RI T...

Page 159: ...derived parameter will not be reported if the relevant input parameter s is are not entered If the default values are used in the calculation of a parameter then a parameter is considered estimated e...

Page 160: ...ype ctCO2 B Vol mL dL mmol L xx x c c c ctHb pH st x xxx c c c VCO2 V dry air fraction xx x x xxx c c c Oximetry parameters The table below lists the oximetry derived parameters ABL83X FLEX correspond...

Page 161: ...e e e capillary pO2 A T mmHg torr xxx x c c c FO2 I RQ T Arterial capillary kPa xx xx e e e p50 mmHg torr xx xx e e e kPa xx xx p50 T mmHg torr xx xx e e c T kPa xx xx p50 st mmHg torr xx xx e e c kPa...

Page 162: ...x x e e c ctHb p50 st T Arterial kPa xx xx e c capillary ctO2 B Vol mL dL mmol L xx x e e c ctHb ctO2 a v Vol mL dL mmol L xx x e e c ctHb Venous Arterial BO2 Vol mL dL mmol L xx x e e c ctHb ctO2 x V...

Page 163: ...b 2 If the sO2 value for establishing the ODC is greater than 0 97 the calculation of the parameter is not performed unless the p50 st value is keyed in 1 If not measured e g ctHb or derived by analyz...

Page 164: ...ressure in kPa fractions not The following symbols are used in the equations log x log10 x ln x loge x pH T Eq 1 13 pH pH 37 pH 37 37 T T 0 0146 0 0065 7 40 cH T Eq 2 c T T H 10 pH 9 Eq 3 4 pCO2 T p T...

Page 165: ...p c c 17674 10 2 0 15158 Eq 6 4 cBase B ox c c c Base B ox Base B tHb O2 s 03062 1 If ctHb is not measured or keyed in the default value will be used If sO2 is not measured it will be calculated from...

Page 166: ...nnot be calculated on the basis of a default ctHb value pO2 T Eq 14 16 17 The standard Oxygen Dissociation Curve ODC is used i e p50 st 3 578 kPa at actual values of pH pCO2 FCOHb FMetHb FHbF see equa...

Page 167: ...7 0 2 3 ti 2 T pO2 A Eq 15 5 p F p p F O A O I amb 6 275 CO RQ O I RQ 1 2 2 2 1 2 1 If FO2 I and RQ are not keyed in they are set to the default values The calculation requires entering the sample typ...

Page 168: ...sis of the default FO2 I value and the calculation requires entering the sample as Arterial or Capillary Eq 19 Refer to Eq 46 10 p50 The ODC is determined as described in equations 46 47 in the sectio...

Page 169: ...0 FHbF 0 The ODC is determined as described in equations 46 47 in the section Oxyhemoglobin Dissociation Curve see equation 47 p50 st ODC S A T where Description See S 0 5 Eq 46 11 A a6 corresponds to...

Page 170: ...rve pO2 x is calculated by a numerical method using Eq Description See 26 1 S ODC P A T Eq 47 26 2 s F F F F O MetHb COHb COHb MetHb 2 i S 1 1 Eq 46 12 26 3 p F s F F O P COHb O COHb MetHb 2 i 2 i 1 1...

Page 171: ...and mixed venous blood respectively The calculation requires two measurements Eq 29 7 BO2 BO c F F 2 1 tHb COHb MetHb BO2 cannot be calculated on the basis of a default ctHb value Eq 30 8 ctO2 x or c...

Page 172: ...apillary Eq 31 D O2 DO tO 2 2 c Qt Q t is the cardiac output and is an input parameter for calculation of D O2 If Q t is not keyed in D O2 will not be calculated The calculation requires entering the...

Page 173: ...sion in mixed venous blood measured and then entered sO2 a oxygen saturation in arterial blood can be measured sO2 A oxygen saturation in alveolar blood calculated from equation 39 where P pO2 A If sO...

Page 174: ...T is calculated from equation 15 35 5 sO2 A T S 35 6 S ODC P A T Eq 47 35 7 P pO2 A T 35 8 A a pH 104 37 0 T T 35 9 T patient temperature keyed in 35 10 pH pH T 146 10 65 10 37 7 40 2 3 If sO2 a 0 97...

Page 175: ...globin Dissociation Curve Qx 2 3 ctO a t 2 i Eq Description See 38 1 t tHb 1 COHb MetHb O O i 2 i c F F s p 9 83 10 5 3 2 38 2 pO2 5 5 00 kPa 38 3 S ODC P A T 38 4 MetHb COHb 1 O COHb 1 5 O i 2 2 F F...

Page 176: ...b 2 2 2 1 Eq 46 9 A a T 37 0 o C Eq 40 FO2Hb F s F F O Hb O 1 COHb MetHb 2 2 If sO2 is not measured it will be calculated from equation 39 If dyshemoglobins FCOHb FMetHb are not known they are set to...

Page 177: ...4 Eq 45 Ref 12 c c Ca Ca pH 2 2 7 4 1 053 7 40 Due to biological variations this equation can only be used for a pH value in the range 7 2 7 6 See Oxyhemoglobin dissociation curve ODC Eq 46 47 Eq 48...

Page 178: ...Return to step 2 9 End of iteration The value for FHbF has converged Eq 50 8 pO2 x T The ODC is determined as described in equations 46 47 in Oxyhemoglobin Dissociation Curve pO2 x is calculated by a...

Page 179: ...with OSA V3 0 pO2 x T can only be calculated if the measured sO2 a 0 97 or p50 st keyed in pO2 x T is tagged with if any of the following parameters sO2 FMetHb FCOHb pO2 pCO2 pH or ctHb is tagged wit...

Page 180: ...ln s 1 s vs ln p used in the mathematical model is expressed by equations 46 3 and 46 4 The symbols a and b reflect the ODC displacement from the reference position to its actual position in this coo...

Page 181: ...6 7 b 0 055 T To To 37 o C 46 8 p p p O C 2 M O where M pCO is taken from the Haldane equation 20 p c p c O O Hb CO COHb 2 2 M to give eq 46 9 46 9 p p p s F F F O O O COHb 1 COHb MetHb 2 2 2 or equat...

Page 182: ...n 46 13 a ac a6 46 14 ac a1 a2 a3 a4 a5 46 15 a1 0 88 pH 7 40 46 16 a2 ln CO 5 33 2 0 048 p 46 17 a3 MetHb 0 7 F 46 18 a4 HbF DPG 0 06 0 02 5 F c 46 19 a5 HbF 0 25 F Determining the actual displacemen...

Page 183: ...reflects the p50 st of the patient i e the particular patient but at standard conditions The ODC is further shifted as determined by the effect of the measured parameters ac to its actual position Th...

Page 184: ...ODC S A T These equations are symbolic representations of the relationship between saturation S tension P displacement A and temperature T To calculate S or P and to further calculate sO2 and pO2 the...

Page 185: ...performed using the equations stated below Temperature T F 32 5 9 o C T T C 32 9 5 o F T cK cNa cCl cX meq L cX mmol L where X is K Na or Cl cCa2 cCa2 meq L 2 cCa2 mmol L or cCa2 mg dL 4 008 cCa2 mmol...

Page 186: ...055506 cGlucose mg dL cLactate 22 cLactate mg dL 9 008 cLactate mmol L or cLactate mmol L 0 11101 cLactate mg dL cLactate meq L cLactate mmol L conversion based on the molecular weight of lactic acid...

Page 187: ...es Values The following default values are used in the ABL800 FLEX analyzers if other values are not keyed in T 37 0 C 99 F FO2 I 0 21 21 0 RQ 0 86 ctHb 9 3087 mmol L 15 00 g dL or 150 g L FCOHb 0 004...

Page 188: ...ometric pressure at high altitudes is affected as the properties of aqueous solutions differ from those of blood The deviation from the pO2 value obtained at sea level can be expressed by an altitude...

Page 189: ...hgen IH Wimberley PD Fogh Andersen N The oxygen status of the arterial blood revised relevant oxygen parameters for monitoring the arterial oxygen availability Scand J Clin Lab Invest 1990 50 Suppl 20...

Page 190: ...9 85 88 18 Siggaard Andersen O Siggaard Andersen M The oxygen status algorithm a computer program for calculating and displaying pH and blood gas data Scand J Clin Lab Invest 1990 50 Suppl 203 29 45 1...

Page 191: ...and consumption The Certificates of Traceability for the calibrating solutions are found at the end of the chapter Contents This chapter contains the following topics General information 7 2 Calibrat...

Page 192: ...mixtures used by the analyzer are named Gas 1 and Gas 2 Expiration date The expiration date of a solution found on the label or on a sticker on the side of the container is stated as a month and year...

Page 193: ...0 Maintains a pH of 6 9 The exact values are included in the bar code Additives Preservatives and surfactants Storage At 2 25 o C 36 77 o F Stability Expiration date and Lot No are printed on a label...

Page 194: ...on date and Lot No are printed on a separate label S5370 Cleaning Additive Use For adding to the S8370 Cleaning solution Composition Contains powdered streptokinase and streptodornase Storage At 2 8 o...

Page 195: ...filled electrode jackets per D755 Membrane Box Inorganic salts organic compounds preservative and surfactant E733 Ca electrode 0 6 mL in 4 pre filled electrode jackets per D733 Membrane Box Inorganic...

Page 196: ...s Manual chapter 4 Analyzer Menus and Programs Quantity 100 mL Delivered with a 1 mL syringe Composition Contains sodium hypochlorite pH 12 Storage Keep in a dark place at 2 8 o C 36 46 o F After use...

Page 197: ...74 64 N2 0 04 O2 11 22 CO2 88 78 N2 WARNING CAUTION Pressurized container Non flammable compressed gas Do not breathe gas Gas mixtures containing less than 19 5 oxygen may cause suffocation Protect fr...

Page 198: ...Traceability certificates...

Page 199: ...ABL800 FLEX Reference Manual 7 Solutions and gas mixtures 7 9...

Page 200: ......

Page 201: ...ABL800 FLEX Reference Manual 7 Solutions and gas mixtures 7 11...

Page 202: ......

Page 203: ...for Oximetry Parameters and Bilirubin 4 4 Corrrection Factors for Electrolyte and Metabolite Parameters 4 7 ctBil sensitivity for pH changes 5 54 D Default Values 6 50 Defintion of terms and test cond...

Page 204: ...on Curve ODC 6 43 P Parameters Ranges and limits 6 3 Symbols 6 2 pCO2 electrode Corrections blood samples 1 17 Corrections expired air samples 1 19 Drift 1 16 Sensitivity 1 16 Stability criteria 1 20...

Page 205: ...5 Stability criteria 2 10 Zero point 2 6 pO2 electrode 2 4 Potentiometric method 1 2 R Reference Electrode 1 8 Repeatability 5 2 Repeatbility chart 5 6 Residual spectrum 3 8 S Sensitivity 1 5 Status...

Page 206: ...ue Radiometer Representative Manufacturer ABL800 FLEX Reference Manual from software identification version 4 12 Publication December 2004 Edition 200412B Code Number 989 963 Specifications are based...

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