Vs-trulab n-p 11382-11383 17.feb2009.xls

TruLab N - Normal control
TruLab P - Pathological control
Parameter declaration / Parameterbezeichnung / Indice paramétre / Indice de parametros
Begriffe
Términos
Ordliste
Constituent
Bestandteil
Constituant
Componento
Bestandsdelar
Componenti
Componento
Bestanddel
TruLab N - Normal control
TruLab P - Pathological control
Parameter declaration / Parameterbezeichnung / Indice paramétre / Indice de parametros
Constituent
Bestandteil
Constituant
Componento
Bestandsdelar
Componenti
Componento
Bestanddel
TSH (Thyreoidea-stimulierendes TSH (Hormone de stimulation de la Version 17.02.2009
Lot No. 11383
No. 5 9050 99 10 061 6 x 5 ml No. 5 9050 99 10 062 20 x 5 ml
Exp. 2011-07
Constituent
Unit Assay value Max. limits** Unit Assay value Max. limits**
Reference method
ALT/GPT
Gas-chromat.-isotope dilution mass spectro. Gas-chromat.-isotope dilution mass spectro.
Gas-chromat.-isotope dilution mass spectro. Gas-chromat.-isotope dilution mass spectro. Gas-chromat.-isotope dilution mass spectro. Gas-chromat.-isotope dilution mass spectro. DiaSys
Albumin
Version 17.02.2009
Lot No. 11383
No. 5 9050 99 10 061 6 x 5 ml No. 5 9050 99 10 062 20 x 5 ml
Exp. 2011-07
Constituent
Unit Assay value Max. limits** Unit Assay value Max. limits**
DiaSys (continued)
Free Glycerol
DiaSys SensoStar / Super GL series
Glucose
Version 17.02.2009
Lot No. 11383
No. 5 9050 99 10 061 6 x 5 ml No. 5 9050 99 10 062 20 x 5 ml
Exp. 2011-07
Constituent
Unit Assay value Max. limits** Unit Assay value Max. limits**
Abbott Aeroset - Architect c series
Albumin
Ion-selective electrode diluted (Indirect) NAC (N-Acetyl-L-Cysteine): Hexokinase/G-6-PDH (NADH) L-Gamma-glutamyl-3-carboxy-4-nitroanilide Substrate mg/dL 5,05 4,25 - 5,86 mmol/L 2,08 1,75 - 2,41
Ion-selective electrode diluted (Indirect) Ion-selective electrode diluted (Indirect) Version 17.02.2009
Lot No. 11383
No. 5 9050 99 10 061 6 x 5 ml No. 5 9050 99 10 062 20 x 5 ml
Exp. 2011-07
Constituent
Unit Assay value Max. limits** Unit Assay value Max. limits**
Beckman Coulter–Access
Cortisol
Beckman Coulter–Immage
Apolipoprotein A
Beckman Coulter–CX/LX/Synchron series
Acetaminophen
Henry, without pyridoxal phosphate 37 °C Henry, without pyridoxal phosphate 37 °C Version 17.02.2009
Lot No. 11383
No. 5 9050 99 10 061 6 x 5 ml No. 5 9050 99 10 062 20 x 5 ml
Exp. 2011-07
Constituent
Unit Assay value Max. limits** Unit Assay value Max. limits**
Olympus–AU400/AU600
Albumin
Version 17.02.2009
Lot No. 11383
No. 5 9050 99 10 061 6 x 5 ml No. 5 9050 99 10 062 20 x 5 ml
Exp. 2011-07
Constituent
Unit Assay value Max. limits** Unit Assay value Max. limits**
Roche–Cobas Integra
Acetaminophen
Version 17.02.2009
Lot No. 11383
No. 5 9050 99 10 061 6 x 5 ml No. 5 9050 99 10 062 20 x 5 ml
Exp. 2011-07
Constituent
Unit Assay value Max. limits** Unit Assay value Max. limits**
Roche Hitachi Series
Acid phosphatase ACP
Version 17.02.2009
Lot No. 11383
No. 5 9050 99 10 061 6 x 5 ml No. 5 9050 99 10 062 20 x 5 ml
Exp. 2011-07
Constituent
Unit Assay value Max. limits** Unit Assay value Max. limits**
Siemens Advia series
Acetaminophen
Enzymatic (CHOD/Trinder) Endpoint reaction IFCC, DGKC 1994, Lactate to Pyruvate 37 °C Version 17.02.2009
Lot No. 11383
No. 5 9050 99 10 061 6 x 5 ml No. 5 9050 99 10 062 20 x 5 ml
Exp. 2011-07
Short forms:
DGKC - Deutsche Gesellschaft für Klinische Chemie
IFCC - International Federation of Clinical Chemistry
NVKC - Nederlandse Vereniging voor Klinidche Chemie
SCE - Scandinavian Committee of Enzymes
SEQC - Sociedad Espanola de Quimica Clinica
SFBC - Société Francaise de Biologie Clinique
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** Ranges of acceptance were calculated as assigned value ± the maximum tolerable deviation of a single value according to the Guidelines of the German Federal Medical Council from 2003 Die Akzeptanzbereiche wurden nach den Richtlinien der Bundesärztekammer von 2003 als Sollwert ± die maximal zulässige Abweichung des Einzelwertes berechnet L’intervalle de confiance a été calculée comme la valeur des méthodes de référence +/- le maximum de l’erreur de mesure admissible selon les recommandations du Comité Médical Fédéral d’Allemagne de 2003 Los rangos de tolerancia han sido calculados como valor de ensayo ± variación máxima tolerable del valor independiente, según las directrices de la Cámara Federal de los Médicos Alemanes de 2003 Acceptansområdet beräknades enligt riktlinjer av Bundesärztekammer från 2003 till att vara riktvärdet +/- den maximalt tillåtna avvikelsen av ett enstaka värde Gli ambiti di accettazione sono stati calcolati sulla base del valore del metodo di riferimento ± tre volte l’errore tollerabile della misura secondo le linee guida del “German Federal Medical Council” dal 2003 As faixas de aceitação foram calculadas com valores assinalados ± três vezes a tolerância máxima de um único valor de acordo com o Guia do Conselho Federal de Medicina da Alemanha de 2003 (Richtlinie der Bundesärztekammer zur Qualitätssicherung quantitativer laboratoriums¬medizinischer Untersuchungen. Deutsches Ärzteblatt 2003; 100:A 3335-38) Manufacturer

Source: http://www.biosys.com.br/data/jpf_kovbio_product/364/trulabplote11383-fev2009.pdf