Synthetic test soil

Details Synthetic test soil Synthetic test soil

1998-07-24

2000-08-22

Carlson, Karen Cochrane

Chemistry: analytical and immunological testing

Clotting or clotting factor level tests

436 66, 435 13, 435214, 530381, 530382, 530385, G01N 3386, G01N 3372, C12Q 156, A61K 3514

Patent

active

061070971

DESCRIPTION:

BRIEF SUMMARY
This application claims priority to PCT Application No. PCT/EP97/00337, Jan. 24, 1997, which claims foreign priority to German Application No. 196 02 673.3, filed Jan. 25, 1996.


FIELD OF THE INVENTION

The invention relates to a synthetic test stain, to the use of a fibrin glue for the preparation of said stain, to a kit for the preparation of a synthetic test stain, to a method of checking the efficiency of a cleaning process, and to a kit for carrying out this method.


BACKGROUND OF THE INVENTION

Many medical and surgical instruments and apparatuses must be cleaned, disinfected and sterilized after use. Cleaning and disinfection are conventionally carried out in so-called automatic washing/disinfecting machines. In these machines the instruments are cleaned, disinfected and dried in preparation for subsequent sterilization.
It is a requirement of the German Law of Medical Products, and comparable regulations in other countries, that the mechanical cleaning process used should be checked for efficiency. On the one hand, this embraces a homologation of the process, which the manufacturer of the automatic washing/disinfecting machine has to undertake before it can be marketed. On the other hand, the user must check the cleaning power of the machine at regular intervals.
To check the cleaning power, so-called test samples with defined test stains are required. The most stubborn stain on medical and surgical instruments and apparatuses, and the one which is hardest to remove, is normally coagulated blood.
In the prior art the homologation to be undertaken by the manufacturer is therefore often carried out with fresh human blood as the test stain. Fresh blood is required because stored blood has had its coagulation reduced by the addition of anticoagulants. However, it is not practicable for the user to employ fresh human blood for regular checking of the cleaning power.
The prior art (established prior use) therefore proposes a variety of test stains such as semolina, egg yolk, starch or stains containing flour. As the properties of all these test stains are markedly different from those of blood, the evidence obtainable on the efficiency of the cleaning process in respect of bloodstains is nonexistent or at best imprecise.


SUMMARY OF THE INVENTION

The present invention provides synthetic test stain comprising a first component selected from the group consisting of fibrin and fibrin precursor, and a combination thereof, and a second component, wherein said second component comprises hemoglobin. In some embodiments, the fibrin precursor is fibrinogen. In other embodiments, the fibrin is selected from the group consisting of monomeric fibrin, polymeric fibrin and crosslinked fibrin. In 'still other embodiments, the synthetic test stain further comprises at least one blood plasma protein. In some preferred embodiments, the blood plasma protein is albumin or a combination of albumin and hemoglobin. In still other embodiments, the synthetic test stain further comprises fibrin glue. In particularly preferred embodiments, the fibrin glue comprises fibrinogen and thrombin.
The present invention also provides kits for the preparation of synthetic test stains, comprising at least one fibrin precursor and an initiator for converting said fibrin precursor to fibrin. In some preferred embodiments, the fibrin precursor comprises fibrinogen. In still other embodiments, the fibrin precursor comprises at least one blood clotting factor. In particularly preferred embodiments, the blood clotting factor is selected from the group consisting of Ca.sup.2+ ions and clotting factor XIII. In yet additional embodiments, the initiator comprises thrombin. In further embodiments, the fibrin precursor and said initiator are lyophilized. In still other embodiments, the kits further comprise at least one solvent, and/or at least one blood plasma protein, and/or at least one fibrinolytic agent, and/or at least one antifibrinolytic agent. In some embodiments, the fibrinolytic agent is plasminogen. In other embodiments, the antifibrinol

REFERENCES:
patent: 5476771 (1995-12-01), Reid et al.
patent: 5508202 (1996-04-01), Enomoto et al.
Tzvetanova and Gotzev, "Improved Biuret Method for Determination of Fibrinogen," Clin. Chem. 34: 430-431 (1988).

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