J-Standardization of an antihemorrhagic potency test of antivenoms prepared from two different Agkistrodon halys venoms

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J. Venom. Anim. Toxins incl. Trop. Dis.

V.12, n.3, p.456-475, 2006.

Original paper - ISSN 1678-9199.

STANDARDIZATION OF AN ANTIHEMORRHAGIC POTENCY TEST OF ANTIVENOMS PREPARED FROM TWO DIFFERENT Agkistrodon halys VENOMS

LEE K. H. (1), HUR S. J. (1), KIM S. N. (1), YOO S. H. (1), SHIN I. S. (1), WON H. J. (1), SHIN K. H. (1), HONG S. H. (1), LEE S. H. (2), MIN H. K. (1), PARK S. N. (1,2)

(1) Department of Biologics Evaluation, Korea Food and Drug Administration, Seoul, Korea; (2) National Institute of Toxicological Research, Korea Food and Drug Administration, Seoul, Korea.

ABSTRACT: To establish Korea National Standards for venoms and antivenoms, it is necessary to have standardized assay methods. In this study, we standardized a method to evaluate the antihemorrhagic potency of two horse-derived antivenoms using rabbit intracutaneous injection. We expressed the capability of these antivenoms to neutralize the hemorrhagic activities triggered by the venoms of Agkistrodon halys from Japan and Jiangzhe Agkistrodon halys from China as Minimum Hemorrhagic Dose (MHD). We also performed cross-neutralization tests employing the parallel line assay on different pairings of venoms and antivenoms to check the possibility of using Jiangzhe Agkistrodon halys venom as a substitute for the standard Agkistrodon halys venom in measurements of the antihemorrhagic activity, since A. halys venom is not easily available. Slope function ratio (S.R.) was 0.957 for Agkistrodon halys venom either with Agkistrodon halys antivenom or with Jiangzhe Agkistrodon halys antivenom (p>0.05). Similarly, S.R. was 0.348 for Jiangzhe Agkistrodon halys venom either with Agkistrodon halys antivenom or with Jiangzhe Agkistrodon halys antivenom (p>0.05). Thus, in this study we established antihemorrhagic potency test methods for both Agkistrodon halys and Jiangzhe Agkistrodon halys antivenoms and we could also show it is possible to use Jiangzhe Agkistrodon halys venom as a standard.

KEY WORDS: antihemorrhagic potency, minimum hemorrhagic dose, Jiangzhe Agkistrodon halys, parallel line assay.

SUE NIE PARK, Blood Products Division, Department of Biologics Evaluation, Korea Food and Drug Administration, 231, Jinheoungno, Eunpyeong-Gu, Seoul 122-704, Korea. Phone: 82 2 380 1711. Fax: 82 2 383 8322 or 82 2 380 1349. Email: suenie@kfda.go.kr.