Modified Nijmegen-Bethesda Assay

Modified Nijmegen-Bethesda Assay
Jun 7, 2018 1:04pm

Precision BioLogic Inc. presented MNBA data at the World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, Scotland, May 20–24. Recognizing the need to improve factor VIII (FVIII ) inhibitor testing for people with hemophilia A, the company studied the agreement between a chromogenic modified Nijmegen-Bethesda assay (MNBA) and a qualitative ELISA test in the detection of FVIII inhibitors in plasma samples.

Data showed that the ELISA was suitable for batch-screening of anti-FVIII antibodies, but that a confirmatory assay, such as a chromogenic MNBA is required for detection of inhibitor antibodies and titer quantification. The study, a collaboration with Roche and Genentech, a member of the Roche Group, was presented as a poster on Monday, May 21:

Poster M-P-59—Agreement Between a Chromogenic Modified Nijmegen-Bethesda Assay and a Qualitative ELISA test in Detection of Factor VIII Inhibitors in Plasma from Persons with Hemophilia A (PwHA) The poster is now available from the publications page of the Precision BioLogic website. Precision BioLogic’s newly developed MNBA kit was used in the study. To eliminate FVIII depleted plasma as a potential source of variant and standardize inhibitor titer measurement, the kit was developed with the following components:

  • Imidazole-buffered pooled normal plasma
  • Imidazole-buffered bovine serum albumin
  • Positive FVIII inhibitor control
  • FVIII inhibitor-free human plasma

All kit components are frozen, like Precision BioLogic’s line of Cryocheck™ diagnostic products, which closely resemble frozen patient samples. Precision BioLogic plans to commercialize the kit and will seek clearance from regulatory authorities around the globe beginning in late 2018.

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Precision BioLogic Inc. presented MNBA data at the World Federation of Hemophilia (WFH) 2018 World Congress in Glasgow, Scotland, May 20–24. Recognizing the need to improve factor VIII (FVIII ) inhibitor testing for people with hemophilia A, the company studied the agreement between a chromogenic modified Nijmegen-Bethesda assay (MNBA) and a qualitative ELISA test in the detection of FVIII inhibitors in plasma samples.

Data showed that the ELISA was suitable for batch-screening of anti-FVIII antibodies, but that a confirmatory assay, such as a chromogenic MNBA is required for detection of inhibitor antibodies and titer quantification. The study, a collaboration with Roche and Genentech, a member of the Roche Group, was presented as a poster on Monday, May 21:

Poster M-P-59—Agreement Between a Chromogenic Modified Nijmegen-Bethesda Assay and a Qualitative ELISA test in Detection of Factor VIII Inhibitors in Plasma from Persons with Hemophilia A (PwHA) The poster is now available from the publications page of the Precision BioLogic website. Precision BioLogic’s newly developed MNBA kit was used in the study. To eliminate FVIII depleted plasma as a potential source of variant and standardize inhibitor titer measurement, the kit was developed with the following components:

  • Imidazole-buffered pooled normal plasma
  • Imidazole-buffered bovine serum albumin
  • Positive FVIII inhibitor control
  • FVIII inhibitor-free human plasma

All kit components are frozen, like Precision BioLogic’s line of Cryocheck™ diagnostic products, which closely resemble frozen patient samples. Precision BioLogic plans to commercialize the kit and will seek clearance from regulatory authorities around the globe beginning in late 2018.

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