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Control Plasma N
assayed for the control of coagulation and Plasma preparation

fibrinolysis tests in the normal range
Intended Use
Control Plasma N is an assayed control for the following parameters in
the normal range:
1. Prothrombin time (PT)
2. Activated partial thromboplastin time (aPTT)
3. Thrombin time (TT)*
4. Batroxobin time*
5. Fibrinogen
6. Coagulation factors II, V, VII, VIII (VIII:C, vWf:RCo), IX, X, XI, XII and
XIII**
7. Inhibitors: Antithrombin III, protein C, protein S**, α2-antiplasmin, C1-
inhibitor**
8. Plasminogen
9. Lupus anticoagulants
The assigned values given for the PT, aPTT, TT and fibrinogen assay
were determined by INSTAND (German Institute for Standardization and
Documentation in the Medical Laboratory) in accordance with the guide-
lines of the Bundesärztekammer (German Federal Chamber of Physi-
cians).
The other assigned values were determined at Dade Behring using
Dade Behring reagents on mechanical and photo-optical coagulation
systems.
If other measurement principles are employed, the coagulation times
obtained may differ from the given assigned values, depending on which
instrument is used.
The nominal values (mean coagulation times) given for the PT, aPTT, the
thrombin time in seconds and the Lupus anticoagulant assay are highly
dependent on method, instrument and working technique and therefore
serve only as a guide.
Reconstitute Control Plasma N in the labelled amount of distilled water,
shaking carefully to dissolve (without foam formation). Before use let
stand at +15 to +25 °C for at least 15 minutes
Storage and Stability
Store Control Plasma N unopened at +2 to +8 °C and use by the date
given on the label.
Stability after reconstitution:
4 hours at + 15 to + 25 °C
4 weeks at - 20 to - 30 °C
Reconstituted Control Plasma N can be frozen and thawed once. The
plasma must be frozen as rapidly as possible in a well-closed container.
Thawing should be accomplished at +37 °C within 10 minutes. The plasma
should not be exposed to +15 to +25 °C for longer than 2 hours after tha-
wing.
Method
For checking the precision in the normal range Control Plasma N is
used with the corresponding reagents in accordance with the assay pro-
tocol in the relevant package insert. The analytical value obtained must
be within the assigned range given in the lot-dependent table of values.
Internal Control
Control Plasma N should be run at least once every 24 hours for any
assays run for patient testing during that interval. Controls should be run
after each new calibration curve. Recalibration may be necessary if con-
trol values are outside the target range. Do not report test results if con-
trols are out of range.
Expected Values
Expected values are provided in the attached table of values and are
generated for each lot of control material. These values are provided as
a guideline only; it is recommended that each laboratory establish its
own acceptable range.

* Not for BFT II Example of Range for Control Plasma N (lot 502726):
** Not available in the U.S.
Reagent % of normal (± 2SD) PR ratio (± 2SD)
Reagents range range
Materials provided
Thromborel® S 101 81 - 121 1.00 0.92 - 1.08
Control Plasma N
Pack containing 6 vials, each for 1 ml, Code No. ORKE 37 or
Pack containing 30 vials, each for 1 ml, Code No. ORKE 67 Bibliography
Each pack of Control Plasma N contains a lot-dependent table of as- 1. Biosafety in Microbiological and Biomedical Laboratories, Centers
signed values. These are valid only for the relevant production lot. for Disease Control/National Institutes of Health, 1993 (HHS Pub. No.
[CDC] 93-8395)
Composition
Control Plasma N is obtained from pooled plasma collected from selec- Thromborel® is a registered trademark of Dade Behring Marburg GmbH
ted healthy blood donors. Control Plasma N is stabilized with HEPES
buffer solution (12g/l) and lyophilized. To avoid contact activation of the
coagulation system the preparation is supplied in siliconized vials. Manufacturer: Dade Behring Marburg GmbH
Control Plasma N contains no preservative. Emil-von-Behring-Str. 76
D-35041 Marburg/Germany
Warnings and precautions
USA Distributor: Dade Behring Inc.
1. For In Vitro Diagnostic Use.
Newark, DE 19714 U.S.A.
2. Each individual blood donation for use in manufacture of Control
Plasma N is tested for hepatitis B surface antigen, anti-HIV and anti-
HCV by FDA required test. Only donations with negative findings are
used for manufacture. Nevertheless, since absence of infectious
agents cannot be proven, all samples (e.g. patient plasma) and pro-
ducts (e.g. control plasma) obtained from human blood should al-
ways be handled with due care, observing the precautions recom-
mended for biohazardous material.1

Dade Behring Marburg GmbH,

ORKE G37 U33 (287) W/H 1 Edition January 2001 D-35041 Marburg/Germany