1. In vitro diagnostic reagent for laboratory and professional use only. Not for medicinal use.

2. The source material used for preparation of the reagent

is screened by third generation assays for HBsAg, HCV

and HIV antibodies and are found to be non-reactive.

However, handle the material as if it is infectious, as no

known test method can assure that infectious agents

are absent.

Preparation of the Reagent

1. Reconstitute the control plasma with exactly 1 mL

of bi-distilled water. Avoid using water-containing

preservatives.

2. Re-stopper the vial and allow to stand until, the

hydration is complete (usually 5–7 minutes).

3. Mix by gently swirling and inversion, avoiding froth

formation. Do not shake.

4. Allow to stand and equilibrate for a further 15 minutes

before use.

5. Use the reconstituted plasma within 3 hours of reconstitution.

Test Procedure

1. Use the reconstituted Plasmatrol controls in the same

manner as freshly prepared titrated platelet poor

plasma from a patient.

2. Use the procedure as laid out in the Uniplastin,

Liquiplastin, Liquicelin-E, Fibroscreen, Fibroquant

pack inserts.

Expected Values

1. The expected value of specific assays are provided on

the assay value sheet accompanying each kit, and are

lot specific.

Clinical Hematology: Bleeding Disorders 297

2. The expected values are obtained using replicate assay

of each manufactured lot of Plasmatrol, manually and

using mechanical coagulometers such as Hemostar,

Hemostar XF.

3. The individual laboratory values should fall within the

expected values.

4. It must however be noted that each laboratory should

establish its own normal values and reference range

according to GLP.

Remarks

1. When used appropriately, Plasmatrol controls are

subjected to the limitations of the assay system

deployed.

2. If proper values are not obtained it may indicate

problems with one or more variables of the assay

system.

3. Stability of the reagent is dependent on storage and

handling conditions. Since these can vary between

laboratories, each laboratory should determine

the stability of the reagent under usual operating

conditions.

4. Incorrect mixing of control plasma and reagent, insufficient preparation of plasma/reagent, contaminated

reagents and glassware, etc. are a potential source of

error.

5. Due to interlaboratory variations in techniques,

standardization of test procedures and calibration

of equipments, some variation from assigned mean

values may be expected.

FIBROSCREEN THROMBIN TIME TEST FOR

QUALITATIVE ESTIMATION OF FIBRINOGEN

FIBROSCREEN®

(Courtesy: Tulip Group of Companies)

Summary

At present there are known to be at least eleven factors in

circulating blood, which are required for normal hemostasis.

Deficiency in any of these factors viz. Factors I, II, V, VII, VIII,

IX, X, XI and XIII results in a notable hemorrhagic condition,