Control Sera

BIOREF - Control Sera

BIOREF control sera consist of human serum where several different analytes are spiked in. These control sera are used for the internal quality control as well as for the external quality control (ring trials) in medical diagnostic laboratories.
For the internal quality control the control sera are analyzed parallel to the patient sera in order to evaluate the accuracy and the precision of the analyses performed. For this purpose the results are compared with the list of target values of the respective control serum.






Characteristics of BIOREF control sera

high stability
At 4°C most of the analytes of the liquid control sera are stable
for at least 6 months.

patient-like composition
The controls consist of 100 % human serum with analytes spiked
in in native form where possible.

simple handling
All controls are liquid. Reconstitution of a lyophilizate is not necessary.

economic handling
Due to the liquid nature and the stability of the controls reconstitution and for most analytes even aliquotation is not necessary. The control material is used more efficiently.

lower error rate
Due to the liquid nature the controls can be pipetted directly. Mistakes which might occur at reconstitution are avoided.

different concentration ranges
BIOREF controls are offered with normal and pathological concentration ranges. Therefore it is possible to check the main clinical decision ranges.

broad analyte spectrum
BIOREF offers control sera for the following analyte ranges:
    Tumor Markers
    Cardiac Markers
    Hormones & Drugs
    Plasma Proteins

suitable for control of accuracy
For every control serum a list of target values is attached.

all BIOREF control sera are labelled with the CE-mark

The performance of quality assurance in medical-diagnostic laboratories is normally regulated according to country-specific law. The EGTM (European Group on Tumor Markers) makes some recommendations for the quality control on an international basis (Quality requirements and control - EGTM recommendations).

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	high stability At 4°C most of the analytes of the liquid control sera are stable for at least 6 months.
	patient-like composition The controls consist of 100 % human serum with analytes spiked in in native form where possible.
	simple handling All controls are liquid. Reconstitution of a lyophilizate is not necessary.
	economic handling Due to the liquid nature and the stability of the controls reconstitution and for most analytes even aliquotation is not necessary. The control material is used more efficiently.
	lower error rate Due to the liquid nature the controls can be pipetted directly. Mistakes which might occur at reconstitution are avoided.
	different concentration ranges BIOREF controls are offered with normal and pathological concentration ranges. Therefore it is possible to check the main clinical decision ranges.
	broad analyte spectrum BIOREF offers control sera for the following analyte ranges: Tumor Markers Cardiac Markers Hormones & Drugs Plasma Proteins
	suitable for control of accuracy For every control serum a list of target values is attached.
	all BIOREF control sera are labelled with the CE-mark