European Heart Journal Advance Access originally published online on July 13, 2005
European Heart Journal 2005 26(18):1930-1931; doi:10.1093/eurheartj/ehi417
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Comment on activity of commercial streptokinase preparations: issue of substandard life-saving drugs: reply
ZLB Behring GmbH
Business Unit Critical Care
35037 Marburg
Germany
Tel: +49 6421 39 4130
Fax: +49 6421 39 4146
E-mail address:
michael.thimme{at}zlbbehring.com
In our paper, ‘Comparative analysis of the activity and content of different streptokinase preparations,’1 we only mentioned the results of the chromogenic assay for the activity measurement of STPase. To confirm, we also tested the samples with a clot-lysis assay as second assay. We have not shown the data of this confirmational tests as they did not significantly differ from the results of the chromogenic assay. The results of both assays are listed in Table 1. As the fibrinolytic activity detected in these two samples was that low, we tested a third batch in a second run, but found no significant difference to the previously tested samples as also shown in Table 1.
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We performed the tests with material directly drawn from the original containers and performed measurements immediately after appropriate dilution. Moreover, the results of our activity tests have also been confirmed by independent investigators.2 Ghosh and Khamar stated in their letter that the detected low activity may be a result of advanced degradation due to inadequate storage or transportation. As previously mentioned, we kept the products, bought for this survey, under the conditions required by the respective manufacturers. This does not exclude a degradation of this product prior to our sample collection. Ghosh and Khamar stated in their letter that the respective streptokinase is remarkably sensitive vs. environmental influences. This may be a cause that we were in fact not able to detect even traces of the original protein. However, in our experience, it is possible to stabilize streptokinase in a way that transportation and storage are not an issue as addressed in the letter, but can be done at elevated temperatures, e.g. at room temperature without significant loss of fibrinolytic activity over time.
In conclusion, we are confident with the results measured for the respective samples in our laboratories, although as stated in our publication as well as in the letter of Ghosh and Khamer, the origin of the detected deficiencies remains unknown.
References
- Hermentin P, Cuesta-Linker T, Weisse J, Schmidt KH, Knorst M, Scheld M, Thimme M. Comparative analysis of the activity and content of different streptokinase preparations. Eur Heart J 2005;26:933–940.
[Abstract/Free Full Text] - Longstaff C, Thelwell C, Whitton C. The poor quality of streptokinase products in use in developing countries. J Thromb Haemost 2005;3:1092–1093.[Medline]
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