Establishment of the 1st World Health Organization International Standard for Plasmodium falciparum DNA for nucleic acid amplification technique (NAT)-based assays
2008

Establishment of the 1st WHO International Standard for Plasmodium falciparum DNA

Sample size: 14 publication Evidence: high

Author Information

Author(s): Padley David J, Heath Alan B, Sutherland Colin, Chiodini Peter L, Baylis Sally A

Primary Institution: National Institute for Biological Standards and Control

Hypothesis

Can a standardized preparation of Plasmodium falciparum DNA improve the consistency of NAT-based assays across laboratories?

Conclusion

The freeze-dried material AA was established as the 1st WHO International Standard for P. falciparum DNA NAT-based assays.

Supporting Evidence

  • The study involved 14 laboratories testing four candidate standards.
  • Sample AA was found to be highly stable and suitable for use as a standard.
  • The mean log10 equivalents/ml for sample AA was determined to be 8.51.

Takeaway

Scientists created a special standard for testing malaria DNA to help labs get the same results when they check for the disease.

Methodology

Fourteen laboratories from 10 countries tested four candidate standards for P. falciparum DNA using qualitative and quantitative NAT-based assays.

Potential Biases

Potential bias due to the use of different assay methods and laboratory practices.

Limitations

Variability in assay sensitivity and differences in laboratory methods may affect results.

Participant Demographics

Laboratories from 10 different countries participated in the study.

Digital Object Identifier (DOI)

10.1186/1475-2875-7-139

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