Lyphochek® Diabetes Control
Levels 1 and 2
Level 1 34001
740 Bilevel 6 x 0.5 mL 2021-10-31 34000 Level 2 34002
740X MiniPak 2 x 0.5 mL
http://www.myeinserts.com/34000
Fecha de revisión 2020-01-29 Indica información revisada
MÉTODO (1)
Nivel 1 - 34001 Nivel 2 - 34002
Unidades (2) Media Rango Media Rango
HEMOGLOBINA A1C
Abbott ARCHITECT cSystems (4P52 Enzymatic) % 4.83 4.25 – 5.40 9.70 8.95 – 10.5
Abbott ARCHITECT iSystems (4P72 Chemiluminescence) (3) % 5.71 4.57 – 6.85 10.4 8.34 – 12.5
ANALYTICON Turbitex HbA1c Biolyzer Series Art# B11081,
B11083 (3) % 4.36 3.71 – 5.01 9.35 7.95 – 10.8
ANALYTICON Turbitex HbA1c Hitachi Series Art# H11081,
H11083 (3) % 4.69 3.99 – 5.39 9.47 8.05 – 10.9
ARKRAY ADAMS A1C HA-8160 (Ver.
4.xx)/HA-8170/HA-8180/HA-8180T/HA-8181/HYBRID
AH-8280/AH-8290/Lite HA-8380/HA-8380V (3) % 5.00 4.50 – 5.50 9.40 8.50 – 10.3
ARKRAY ADAMS A1C HA-8180V (3) % 5.10 4.60 – 5.60 9.70 8.80 – 10.6
Beckman Coulter AU Systems (REF B00389) % 5.21 4.51 – 5.91 9.25 7.84 – 10.7
Beckman Coulter UniCel DxC Series % 5.35 4.80 – 5.90 10.1 9.14 – 11.1
Bio-Rad D-10 A1c Dual Program 220-0201 (3) (4) % 5.10 4.50 – 5.70 10.0 8.80 – 11.2
Bio-Rad D-10 Dual A2/F/A1c Program 220-0201 (3) (4) % 5.30 4.70 – 5.90 9.90 8.70 – 11.1
Bio-Rad D-10 Hemoglobin A1c 220-0101 / 12000949 (3) (4) % 5.10 4.50 – 5.70 10.0 8.80 – 11.2
Bio-Rad D-100 HbA1c (3) (4) % 5.17 4.60 – 5.80 9.74 8.50 – 10.9
Bio-Rad VARIANT II Dual Kit Beta-Thal 270-2500 (3) (5) % 5.00 4.40 – 5.60 10.1 8.90 – 11.3
Bio-Rad VARIANT II HbA1c Dual Program 270-2500 (3) (5) % 5.10 4.50 – 5.70 10.1 8.90 – 11.3
Bio-Rad VARIANT II Hemoglobin A1c Program 270-2101NU (3)
(4) % 5.20 4.60 – 5.80 9.90 8.70 – 11.1
Bio-Rad VARIANT II TURBO HbA1c Kit 2.0 270-2455 /
12000447 (3) (4) % 5.20 4.60 – 5.80 9.80 8.60 – 11.0
Bio-Rad VARIANT II TURBO HbA1c Kit 2.0 270-2455EX (3) (4) % 5.20 4.60 – 5.80 9.80 8.60 – 11.0
Bio-Rad VARIANT II TURBO Hemoglobin A1c Program 270-2415
/ 270-2716 / 270-2417 (3) (4) % 5.30 4.70 – 5.90 10.2 9.00 – 11.4
Diazyme Direct Enzymatic HbA1c DZ168C (Rochi Hitachi
Systems, International / Modular) (3) % 5.90 4.70 – 7.10 9.50 7.60 – 11.4
HemoCue HbA1c 501 (3) % 5.10 4.09 – 6.11 9.70 7.77 – 11.6
Infopia / Osang Healthcare Clover A1c (3) % 5.00 4.01 – 6.00 9.50 7.61 – 11.4
Infopia / Osang Healthcare Clover A1c Self (3) % 4.90 3.92 – 5.88 9.20 7.37 – 11.0
JEOL BM Test HbA1c (3) % 4.80 3.84 – 5.76 9.36 7.49 – 11.2
Ortho VITROS Microtip Series (HBA1C REF 6842905) % 5.06 4.47 – 5.65 9.73 8.52 – 10.9
Pointe Scientific Inc. Hemoglobin A1c H7546 (Beckman Coulter
AU Systems) (3) % 4.30 3.70 – 4.90 10.5 8.90 – 12.1
PTS Diagnostics A1CNOW+ (3) % 5.02 4.02 – 6.02 9.44 7.55 – 11.3
Roche cobas c System (Tina-quant hbA1c Gen2/Gen3) % 5.06 4.50 – 5.62 9.62 8.71 – 10.5
Roche cobas INTEGRA (Tina-quant Hemoglobin A1c) % 5.23 4.70 – 5.77 9.70 8.92 – 10.5
SAKAE A1c Gear (3) % 5.20 4.30 – 6.20 10.0 8.00 – 12.0
SAKAE A1c iGEAR (3) % 5.20 4.30 – 6.20 10.0 8.00 – 12.0
Página 1 ESPAÑOL/Spanish • 2019-03 • 4037-00
8
Lyphochek® Diabetes Control, Levels 1 and 2
MÉTODO (1)
Nivel 1 - 34001 Nivel 2 - 34002
Unidades (2) Media Rango Media Rango
HEMOGLOBINA A1C (continuación)
SAKAE A1c iGEAR QUICK (3) % 5.20 4.30 – 6.20 10.0 8.00 – 12.0
Samsung LABGEO PT10 (3) % 5.30 4.00 – 6.20 11.1 8.70 – 13.4
SEBIA CAPI 3 Hb A1c (Cat. 2515) / CAPI 3 INSTRUMENT (3) % 4.90 4.30 – 5.50 10.0 9.00 – 11.0
SEBIA CAPILLARYS hb A1c (Cat. 2015) / CAPPILARYS 2 FLEX
PIERCING INSTRUMENT (3) % 4.90 4.30 – 5.50 10.1 9.10 – 11.1
SEBIA MINICAP Hb A1c (Cat. 2215) / MINICAP FLEX PIERCING
INSTRUMENT (3) % 4.90 4.30 – 5.50 10.0 9.00 – 11.0
SEKISUI NORUDIA N hbA1c (3) % 4.77 3.82 – 5.72 9.26 7.41 – 11.1
Siemens ADVIA Chemistry Systems (Enzymatic Hemoglobin
A1c, A1c_E / A1c_EM) (3) % 4.60 4.28 – 4.93 9.40 9.06 – 9.74
Siemens ADVIA Chemistry Systems (Hemoglobin A1c_3) (3) % 5.20 4.40 – 5.90 9.30 7.90 – 10.7
Siemens Atellica Solution Enzymatic Hemoglobin A1c
(A1c_E) (3) % 4.68 3.95 – 5.42 8.98 7.95 – 10.0
Siemens DCA Series % 5.22 4.71 – 5.73 9.57 8.65 – 10.5
Siemens Dimension Series (A1C REF DF105B) (3) % 5.20 4.90 – 5.60 9.80 9.50 – 10.1
Siemens Dimension Series (HB1C REF DF105A) % 5.23 4.53 – 5.93 9.78 8.62 – 10.9
Siemens Dimension Vista Systems A1C REF K3105B (3) % 5.10 4.90 – 5.30 9.20 8.90 – 9.50
Siemens Dimension Vista Systems HbA1C REF K3105A % 5.20 4.59 – 5.81 9.35 8.37 – 10.3
TOSOH G11 Automated HPLC Analyzer (3) % 5.10 4.60 – 5.60 9.60 8.60 – 10.6
TOSOH G7 Automated HPLC Analyzer (3) % 5.20 4.70 – 5.70 9.70 8.70 – 10.7
Tosoh G8 Automated HPLC Analyzer (3) % 5.20 4.70 – 5.70 9.80 8.80 – 10.8
TOSOH GX Automated HPLC Analyzer (3) % 5.20 4.70 – 5.70 9.90 8.90 – 10.9
TOSOH HLC-723 G8,G9,G11 (3) % 5.20 4.70 – 5.70 9.60 8.70 – 10.6
Trinity Biotech Affinity HPLC (3) % 4.98 4.70 – 5.29 9.75 9.17 – 10.4
Trinity Biotech Premier Hb9210 (3) % 4.93 4.65 – 5.23 9.78 9.17 – 10.4
NOTAS AL PIE DE PÁGINA
(1) Es posible que no todas las notas al pie sean de aplicación para la tabla de datos personalizada que ha seleccionado.
(2) Unidades NGSP = %; unidad IFCC = mmol/mol.
(3) Los valores asignados se determinaron utilizando el protocolo del fabricante del reactivo o instrumento y puede que no representen rangos de ±3s.
(4) Los valores asignados se obtuvieron utilizando una dilución al 1:300 (pipetee 1,5 ml de la solución de lavado/diluyente en un vial de 1,5 ml etiquetado, y
después 5 µl del control reconstituido. Tape cada vial del control y mézclelo bien).
(5) Los valores asignados se obtuvieron utilizando una dilución al 1:200 (pipetee 1,0 ml de la solución de lavado/diluyente en un vial de 1,5 ml etiquetado, y
después 5 µl del control. Tape cada vial del control y mézclelo bien).
Página 2 ESPAÑOL/Spanish • 2019-03 • 4037-00