Seventeen laboratories from 14 countries participated in an international collaborative study to establish a WHO International Standard for Toxoplasma gondii DNA nucleic acid amplification technology (NAT) assays. In all, 20 separate data sets were collected from these laboratories. Five samples, AA which was lyophilised and BB, CC, DD and EE which were liquid preparations, were analysed using several different NAT assays. The mean T. gondii DNA content of each sample was determined from the study. The mean log10 “equivalents”/ml were 6.0 for sample AA, 5.91 for sample BB, 2.88 for sample CC, 3.01 for sample DD and 6.48 for sample EE. Predictions of the stability of the freeze-dried preparation AA indicate that it is extremely stable and suitable for long term use. On the basis of the collaborative study data and the results of the stability studies, the freeze-dried material, AA is proposed the first International Standard for T. gondii DNA NAT assays. The code number of AA is 10/242 and the proposed potency is 1x106 International units per ml based upon this study. Each vial contains the equivalent of 0.5 ml of material, and the content of each vial would be 5x105 IU/ml.

An International Collaborative Study to establish a WHO Internal Standard for Toxoplasma gondii DNA Nucleic acid amplification technology assays / Padley, D. J; Heath, A. B.; Chiodini, P. L.; Guy, E.; Evans, R.; Pereira Chioccola, V. L.; Lass, A.; Jeoffreys, N.; Guruz, Y.; Caner, A.; Doskaya, M.; Atalay, E.; Chatterton, J.; Mahittikorn, A.; Bastien, P.; Varlet Marie, E.; Ji, D.; Chapey, E.; Lugert, R.; Montoya, J. G.; Calderaro, Adriana; Roelfsema, J.; Nielsen, H. V.; Press, C.. - (2014).

An International Collaborative Study to establish a WHO Internal Standard for Toxoplasma gondii DNA Nucleic acid amplification technology assays

CALDERARO, Adriana;
2014-01-01

Abstract

Seventeen laboratories from 14 countries participated in an international collaborative study to establish a WHO International Standard for Toxoplasma gondii DNA nucleic acid amplification technology (NAT) assays. In all, 20 separate data sets were collected from these laboratories. Five samples, AA which was lyophilised and BB, CC, DD and EE which were liquid preparations, were analysed using several different NAT assays. The mean T. gondii DNA content of each sample was determined from the study. The mean log10 “equivalents”/ml were 6.0 for sample AA, 5.91 for sample BB, 2.88 for sample CC, 3.01 for sample DD and 6.48 for sample EE. Predictions of the stability of the freeze-dried preparation AA indicate that it is extremely stable and suitable for long term use. On the basis of the collaborative study data and the results of the stability studies, the freeze-dried material, AA is proposed the first International Standard for T. gondii DNA NAT assays. The code number of AA is 10/242 and the proposed potency is 1x106 International units per ml based upon this study. Each vial contains the equivalent of 0.5 ml of material, and the content of each vial would be 5x105 IU/ml.
An International Collaborative Study to establish a WHO Internal Standard for Toxoplasma gondii DNA Nucleic acid amplification technology assays / Padley, D. J; Heath, A. B.; Chiodini, P. L.; Guy, E.; Evans, R.; Pereira Chioccola, V. L.; Lass, A.; Jeoffreys, N.; Guruz, Y.; Caner, A.; Doskaya, M.; Atalay, E.; Chatterton, J.; Mahittikorn, A.; Bastien, P.; Varlet Marie, E.; Ji, D.; Chapey, E.; Lugert, R.; Montoya, J. G.; Calderaro, Adriana; Roelfsema, J.; Nielsen, H. V.; Press, C.. - (2014).
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11381/2819188
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