| 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
URINE CHEMISTRY CONTROL "Level I/Level II" |
Aqueous solutions to monitor the reproducibility and accuracy
of methods and analyses
(Internal Quality Control) used for the determination
of following analytes found in human
urines: uric acid, Creatinine, magnesium, phosphorous,
glucose, urinary proteins, urea.
BIOLABO
Urinary Control:
95012, R1 : 1 x 10 mL (Level I), ), R2 : 1 x 10 mL (Level II),
See
PDF insert
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 and Lipids CONTROLS AND CALIBRATORS |
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 and Lipids Controls Level
1 and Level 2
BIOLABO Controls HDL/LDL/CK-MB and lipids (freeze-dried
human serum).
2 different levels available to monitor accuracy
and precision during the determination of following
analysis:
HDL cholesterol (direct method), HDL cholesterol
(PTA method), LDL cholesterol
(direct method), Total cholesterol, unesterified
cholesterol, triglycerides, phospholipids and
CK-MB activity.
Suitable for manual procedure or automated instruments.
In case of use with another reagent, refer to corresponding
instructions.
SERUM
CONTROL HDL / LDL / CK-MB and Lipids "Level 1",
95516, R1 : 2 x 2 mL, R2 : 1 x 5 mL See
PDF insert
SERUM
CONTROL HDL / LDL / CK-MB and Lipids "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. |