A Validation Study of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Polyvalent Horse Snake Antivenom

References

1. 1.↵
   1. Harrison R. A.,
   2. Hargreaves A.,
   3. Wagstaff S. C.,
   4. Faragher B.,
   5. Lalloo D. G.

   Snake Envenoming: A Disease of Poverty. PLoS Neglected Trop. Dis. 2009, 3 (12), e569.

   OpenUrl
2. 2.↵
   Rabies and Envenomings: A Neglected Public Health Issue. Report of a Consultative Meeting, World Health Organization, Geneva, Switzerland. https://apps.who.int/iris/handle/10665/43858 (accessed Jan 10, 2007).
3. 3.↵
   1. Gutiérrez J. M.,
   2. Theakston R. D.,
   3. Warrell D. A.

   Confronting the Neglected Problem of Snake Bite Envenoming: The Need for a Global Partnership. PLoS Med. 2006, 3 (6), e150.

   OpenUrlCrossRefPubMed
4. 4.↵
   1. Kasturiratne A.,
   2. Wickremasinghe A. R.,
   3. de Silva N.,
   4. Gunawardena N. K.,
   5. Pathmeswaran A.,
   6. Premaratna R.,
   7. Savioli L.,
   8. Lalloo D. G.,
   9. de Silva H. J.

   The Global Burden of Snakebite: A Literature Analysis and Modelling Based on Regional Estimates of Envenoming and Deaths. PLoS Med. 2008, 5 (11), e218.

   OpenUrlCrossRefPubMed
5. 5.↵
   1. Bon C.,
   2. Goyffon M.

   1. Grandgeorge M.,
   2. Véron J. L.,
   3. Lutsch C.,
   4. Makula M. F.,
   5. Riffard P.

   Preparation of Improved F(ab')2 Antivenoms. An Example: New Polyvalent European Viper Antivenom (Equine). In Envenomings and Their Treatments, Bon C., Goyffon M., Eds.; Fondation Marcel Mérieux: Lyon, 1996; pp 161–172.
6. 6.↵
   1. Al-Abdulla I.,
   2. Garnvwa J. M.,
   3. Rawat S.,
   4. Smith D. S.,
   5. Landon J.,
   6. Nasidi A.

   Formulation of a Liquid Ovine Fab-Based Antivenom for the Treatment of Envenomation by the Nigerian Carpet Viper (Echis ocellatus). Toxicon 2003, 42 (4), 399–404.

   OpenUrlPubMed
7. 7.↵
   1. Acconci C.,
   2. Legallais C.,
   3. Vijayalakshmi M.,
   4. Alves Bueno S. M.

   Depyrogenation of Snake Antivenom Serum Solutions by Hollow Fiber-Based Pseudobioaffinity Filtration. J. Membr. Sci. 2000, 173 (2), 235–245.

   OpenUrl
8. 8.↵
   1. Silveira,
   2. Simone R.,
   3. Andrade,
   4. Cleber L.,
   5. Schmidt,
   6. Renata S.,
   7. Casali A. G.,
   8. Dalmora S. L.

   Comparative Evaluation of Pyrogens Tests in Pharmaceutical Products. Braz. J. Microbiol. 2004, 35 (1-2), 48–53.

   OpenUrl
9. 9.
   1. Levin J.,
   2. Bang F. B.

   The Role of Endotoxin in the Extracellular Coagulation of Limulus Blood. Bull. Johns Hopkins Hosp. 1964, 115, 265–274.

   OpenUrlPubMedWeb of Science
10. 10.↵
    U.S. Food and Drug Administration. Guideline on Validation of the Limulus Amebocyte Lysate Test as an End-Product Endotoxin Test for Human and Animal Parenteral Drugs, Biological Products, and Medical Devices. U.S. Department of Health and Human Services: Rockville, MD, 1987.
11. 11.↵
    1. Akbar John B.,
    2. Kamaruzzaman B. Y.,
    3. Jalal K. C. A.,
    4. Zaleha K.

    TAL - A Source of Bacterial Endotoxin Detector in Liquid Biological Samples. Int. Food Res. J. 2012, 19 (2), 423–425.

    OpenUrl
12. 12.↵
    1. Twohy C. W.,
    2. Duran A. P.,
    3. Munson T. E.

    Endotoxin Contamination of Parenteral Drugs and Radiopharmaceuticals as Determined by the Limulus Amebocyte Lysate Method. J. Parenter. Sci. Technol. 1984, 38 (5), 190–201.

    OpenUrlPubMed
13. 13.↵
    1. Dawson M. E.

    Interference with the LAL Test and How to Address It. LAL Update 2005, 22 (3), 1–5. https://www.acciusa.com/pdfs/newsletter/LAL%20Update%20Vol%2022_No3%20rev%20001.pdf (accessed Jan 1, 2012).

    OpenUrl
14. 14.↵
    1. Pennamareddy R.,
    2. Prabakar K.,
    3. Pandiyan J.

    Sorting out of Interference in Detection of Endotoxins in Biotherapeutic Drugs. Indian J. Sci. Technol. 2009, 2 (11), 20–22.

    OpenUrl
15. 15.↵
    1. Roth R. I.,
    2. Levin F. C.,
    3. Levin J.

    Optimization of the Detection of Bacterial Endotoxin in Plasma with the Limulus Test. J. Lab. Clin. Med. 1990, 116 (2), 153–161.

    OpenUrlPubMedWeb of Science
16. 16.↵
    1. Novitsky T. J.

    Limulus Amebocyte Lysate (LAL) Detection of Endotoxin in Human Blood. J. Endotoxin Res. 1994, 1 (4), 253–263.

    OpenUrl
17. 17.↵
    1. Cooper J. F.

    Resolving LAL Test Interferences. J. Parenter. Sci. Technol. 1990, 44 (1), 13–15.

    OpenUrlPubMed
18. 18.↵
    1. Cooper J. F.

    Validation of Bacterial Endotoxins Test Methods. LAL Times 1999, 6 (2).
19. 19.↵
    1. Donovan M. A.

    Overcome Your Inhibitions. BioWhittaker LAL Review. Winter, 1994.
20. 20.↵
    U.S. Pharmacopeial Convention, General Chapter <85> Bacterial Endotoxins Test, In USP 32–NF 27; USP: Rockville, MD, 2009; pp 88–90.
21. 21.↵
    Ministry of Health Labour and Welfare of Japan. General Tests, Process and Apparatus–4.01 Bacterial Endotoxins Test. In The Japanese Pharmacopoeia (English Version), 15th Edition; MHLW: Tokyo, 2006; pp 77–81.
22. 22.↵
    1. Gutiérrez J. M.,
    2. Fan H. W.,
    3. Silvera C. L. M.,
    4. Angulo Y.

    Stability, Distribution and Use of Antivenoms for Snakebite Envenomation in Latin America: report of a Workshop. Toxicon 2009, 53 (6), 625–630.

    OpenUrlCrossRefPubMed
23. 23.↵
    1. Sani I.,
    2. Umar R. A.,
    3. Hassan S. W.,
    4. Faruq U. Z.

    Antisnake Venoms and Their Mechanisms of Action: A Review. Saudi J. Med. Pharm. Sci. 2018, 4 (5), 512–520.

    OpenUrl
24. 24.↵
    1. Fujita Y.,
    2. Tokunaga T.,
    3. Kataoka H.

    Saline and Buffers Minimize the Action of Interfering Factors in the Bacterial Endotoxins Test. Anal. Biochem. 2011, 409 (1), 46–53.

    OpenUrlPubMed
25. 25.↵
    1. Hassan R.,
    2. Elnagar W.,
    3. Habib E.,
    4. El-Mowafy M.,
    5. El-Sandouby A.

    Evaluation of LAL Test Interference in Some Egyptian Parenteral Drugs Alone and in Combinations. N. Egypt. J. Microbiol. 2017, 48, 73–82.

    OpenUrl
26. 26.↵
    1. Hider R. C.,
    2. Barlow D.

    1. Poole S.

    Pyrogen Testing of Polypeptide and Protein Drugs. In Polypeptide and Protein Drugs: Production, Characterization and Formulation; Hider R. C., Barlow D. Eds.; Ellis Horwood, 1991; pp 146–153.
27. 27.↵
    1. Ohno N.,
    2. Emori Y.,
    3. Yadomae T.,
    4. Saito K.,
    5. Masuda A.,
    6. Oikawa S.

    Reactivity of Limulus Amebocyte Lysate towards (1-3) β-D-Glucans. Carbohydr. Res 1990, 207 (2), 311–318.

    OpenUrlCrossRefPubMedWeb of Science
28. 28.↵
    1. Pearson F. C.,
    2. Weary M.

    The Significance of Limulus Amebocyte Lysate Test Specificity on the Pyrogen Evaluation of Parenteral Drugs. J. Parenter. Drug Assoc. 1980, 34 (2), 103–108.

    OpenUrlPubMed
29. 29.↵
    1. Tanaka S.,
    2. Iwanaga S.

    Limulus Test for Detecting Bacterial Endotoxins. Methods Enzymol. 1993, 223, 358–364.

    OpenUrlPubMedWeb of Science