| A
High Level of Confidence: | (Figures
established on 31/08/2001, on the past 18 months) of BIOLABO calibration
and control sera supplied world-wide. of calibration and
control tests for biochemistry analytes performed with BIOLABO Calibration
and Control material. (base:
15 µl per test) of control sera
sold in France to proficiency organisation and/or scientific organisations for
External Quality Assessment schemes.
| Free
of charge external quality control program for customers | In
certain countries, BIOLABO offers its customers, free of charge under certain
conditions, a monthly external quality control program. Please
contact us for further information.
|
BIOLABO MULTICALIBRATOR is a
bovine serum to be used as a reference material for the
calibration of the most common Clinical Chemistry analytes.
Traceable to SRM ® (Standard Reference Material
®), BIOLABO MULTICALIBRATOR provides
analytical values allowing the calibration in optimised
conditions. Values for catalytic activities of
enzymes are established under strictly controlled metrological
conditions. Values of uncertainty
are also reported.
Excerpt of Directive 98/79/CE of European Parliament
and the Council of 27 October 1998
related to in vitro diagnostic devices:
"
The traceability of values assigned to calibrators and/or control
materials must be
assured through available reference measurement procedures
and/or available
reference materials of a higher order.
"
(in
Annex 1: Essential Requirements, §A.3.)
BIOLABO
MULTICALIBRATOR:
95015, 10 x 5 ml See
PDF insert
| BIOLABO
EXATROL-N & BIOLABO EXATROL-P |
For a daily Quality Control, BIOLABO EXATROL-N
and BIOLABO EXATROL-P are recommended
for all your routine biochemistry analytes.
Both assayed bovine control sera, they
include values for over 20 routine parameters. According
to "the state of the art", target values and range values are established
by statistics using results obtained in qualified laboratories
under reproducible conditions. Tests are performed with BIOLABO reagents and
results are commutative to reagents using similar methods.
Values of BIOLABO EXATROL-N and BIOLABO EXATROL-P are traceable to
SRM ® (Standard Reference Material ®).
Values for catalytic activities of enzymes re-established
under strictly controlled metrological
conditions. The characteristics
of the matrix of BIOLABO EXATROL-N and BIOLABO EXATROL-P (bovine
serum) is very close to the ones of a current patient sample. No addition
of specific proteins, hormones or drugs interfere in the performances.
BIOLABO EXATROL-N,
normal values: 95010,
10 x 5 ml See
PDF insert BIOLABO EXATROL-P,
pathological values:
95011, 10 x 5 ml See
PDF insert
| BIOLABO
PAEDIATRIC CONTROL |
BIOLABO PAEDIATRIC CONTROL, lyophilised human serum. Paediatric values
(very high bilirubin and PAL values). Its main advantages are: Commutability
between the control serum and the patient sample, excellent stability
before and after reconstitution, traceable values. BIOLABO
PAEDIATRIC CONTROL,
95403, R1 : 3 x 3 mL, R2 : 1 x 10 mL, See
PDF insert |
| BIOLABO
LIPASE CALIBRATOR |
Preparation of pancreatic human lipase to calibrate
during Lipase activity measurement with Lipase reagent.
BIOLABO REF 99881 or REF 99891.
LIPASE
CALIBRATOR,
95801, R1 : 1 x 3 mL, R2 : 1 x 5 mL See
PDF insert
|
| NORMAL
AND DEFICIENT G6PDH CONTROL |
NORMAL and DEFICIENT G6PDH CONTROL Lyophilised red
cells (Human Source) intended to monitor the reproducibility
and accuracy of G6-PDH activity with BIOLABO reagent: REF 97089
NORMAL
CONTROL G6PDH,
95089, R1 : 6 x 0,5 mL, R2 : 1 x 5 mL
See
PDF insert
DEFICIENT
CONTROL G6PDH,
95289, R1 : 6 x 0,5 mL, R2 : 1 x 5 mL
See
PDF insert
|
| BIOLABO
HDL/LDL/CK-MB CALIBRATORS AND CONTROLS |
HDL / LDL / CK-MB Calibrator
Preparation of lyophilised Human serum containing different
forms of lipoproteins, including high density lipoproteins
(HDL), low density lipoproteins (LDL) and CK-MB.
To calibrate during HDL-Cholesterol Assay (Direct
method and PTA method).
To calibrate during LDL-Cholesterol Assay (Direct
Method).
To calibrate during CK-MB activity measurement
(immuno-inhibition method).
Main advantages: Traceable to international standards
SRM 1951b, and values around the medical decision
level.
HDL
/ LDL / CK-MB Calibrator ,
95506, R1 : 2 x 2 mL, R2 : 1 x 5 mL See
PDF insert
HDL / LDL / CK-MB Controls Level 1
and Level 2
Preparation of lyophilised Human serum containing
different forms of lipoproteins, including high density
lipoproteins (HDL), low density lipoproteins (LDL) and CK-MB.
2 different levels available to monitor the reproductibility
and accuracy of methods and analysis performed with BIOLABO
kits for the following analysis :
BIOLABO HDL-Cholesterol (direct method)
REF 90206 (200-250 Tests), REF 90406 (400-500 Tests),
REF 90426 (2000-2500 Tests).
BIOLABO HDL-Cholesterol (PTA method)
REF 86516 (1 x 125 mL), REF 86536 (1 x 30 mL).
BIOLABO LDL-Cholesterol (direct method)
REF 90416 (100-125 tests), REF 90816 (200-250 Tests).
BIOLABO CK-MB (immuno-inhibition method)
REF 97217 (10 x 3 mL), REF 97317 (8 x 20 mL).
Suitable for manual procedure or automated instruments.
In case of use with another reagent, refer to corresponding
instructions.
SERUM
CONTROL HDL / LDL / CK-MB "Level 1",
95516, R1 : 2 x 2 mL, R2 : 1 x 5 mL See
PDF insert
SERUM
CONTROL HDL / LDL / CK-MB "Level 2",
95526, R1 : 2 x 2 mL, R2 : 1 x 5 mL See
PDF insert
|
| External
Quality Assessment Scheme (E.Q.A.S) | Scientific
societies, associations of pathologists, or all other qualified organisation are
invited to get in touch with BIOLABO experts in order to study their
specifications for the production of control solutions.
BIOLABO keeps up with the latest standards
to apply them in its SOP's (Standard Operating Procedures) as soon as
they come to its knowledge. |