Helen Biosciences Haemostasis Reagents
Helena Biosciences Logo
Helena Biosciences Logo

Calibrators & Quality Control Material

Third party solutions for Haematology

Helena Biosciences’ extensive range of controls are manufactured independently of your existing system, offering complete impartial assay validation as recommended by the ISO standards.

These controls are manufactured using human plasma as the base material, giving a product similar in composition to the patient samples to be tested. Controls are manufactured to give results at multiple levels, including within the normal reference interval, as well as close to medical decision limits.

Our third party controls have a long shelf life so that the same lot can be used over multiple changes in reagents, allowing the laboratory to detect any shifts in results which may occur with changes to the test system.

QC and Reference Plasma Product Matrix for Haemostasis
Routine Control N, A and SA

Routine Control N, Routine Control A and Routine Control SA are for use as normal, moderately prolonged and markedly prolonged controls for PT and aPTT assays. They are also assayed for Class Fibrinogen, Thrombin Time and Antithrombin Xa and are prepared from normal human plasma.

Speciality Assayed Control N, A

Speciality Assayed Control N (SAC - N) and Speciality Assayed Control A (SAC-A) may be used as a normal control and abnormal control when assaying for Factors II, V, VII, VIII, IX, X, XI, XII, Fibrinogen, von Willebrand Factor, antigenic and functional Protein C and Protein S (total and free), as well as the chromogenic assays including Antithrombin Xa, Protein C and Plasminogen.

LA Positive Control S

LA Positive Control S is prepared from human donor plasma positive for Lupus anticoagulants. The control gives results typical of a Lupus Anticoagulant patient in DRVVT Screen, DRVVT Confirm and APTT-based tests.

D-Dimer Control H/L

The D-Dimer Control H/L kit contains plasmas with low and high levels of D-Dimer. The plasmas are intended to be used in conjunction with the Helena Biosciences’ latex immunoassays for D-Dimer.

Ristocetin Cofactor Abnormal Control

For use as an abnormal control in the Ristocetin Cofactor Assay of human plasma.

Calibration Plasma

Calibration Plasma is prepared from normal human plasma and may be used as a reference plasma for the following assays: Factors II, V, VII, VIII, IX, X, XI, XII, Fibrinogen, von Willebrand Factor, antigenic and functional Protein C, Protein S (total and free), as well as the chromogenic assays including Antithrombin Xa, Protein C and Plasminogen.

ISI Calibrant Plasma Set

The ISI Calibrant Plasma Set is designed to simplify the laboratory calibration of Thromboplastin International Sensitivity Index (ISI) values when using automated equipment for the determination of Prothrombin time. The ISI Calibrant Plasma Set is intended for use with Thromboplastins of human or rabbit origin and its performance has been validated with Thromboplastin ISIs less than 2.00.

Calibration Plasma Set

The Calibration Plasma set is designed to simplify the laboratory calculation of Thromboplastin ISI values when using automated instruments for the determination of Prothrombin Time. It used for: Generating a %PT Calibration Curve, generating an INR Reference Curve for the direct INR determination of a patient sample, generating specific ISI and MNPT values for the system, reagent and instrument combination used by the laboratory.

Fibrinogen Calibrator

For use as a calibrator in the assay of fibrinogen in human plasma. May be used in conjunction with Helena Biosciences’ Clauss Fibrinogen (Thrombin Only) (REF 5374, 5378) or Clauss Fibrinogen 100 (REF 5376, 5376H).

INR Reference Set

The INR Reference Set can be used to assure the laboratory of the quality of results produced under the Local System ISI regime by monitoring the laboratory control of INR values. The INR Reference Set is a set of 3 lyophilised human plasmas which have certified INR values. These values are assigned using the current WHO reference Thromboplastin and the manual tilt tube technique. Each set contains 4 vials of each plasma, with certified INR values in the ranges 1-2, 2-3 and 3-4.