ABSTRACT
The ability to transfer information about the performance, safety, and environmental impacts of a genetically modified (GM) crop from confined field trials (CFTs) conducted in one location to another is increasingly gaining importance in biosafety regulatory assessment and decision-making. The CFT process can be expensive, time-consuming, and logistically challenging. Data transportability can help overcome these challenges by allowing the use of data obtained from CFTs conducted in one country to inform regulatory decision-making in another country. Applicability of transported CFT data would be particularly beneficial to the public sector product developers and small enterprises that develop innovative GM events but cannot afford to replicate redundant CFTs, as well as regulatory authorities seeking to improve the deployment of limited resources. This review investigates case studies where transported CFT data have successfully been applied in biosafety assessment and decision-making, with an outlook of how African countries could benefit from a similar approach.
Subject(s)
Crops, Agricultural , Plants, Genetically Modified , Crops, Agricultural/genetics , Crops, Agricultural/growth & development , Plants, Genetically Modified/genetics , Africa , Humans , Decision Making , Agriculture/methods , Agriculture/legislation & jurisprudenceABSTRACT
Serosurveys are useful for assessing population susceptibility to vaccine-preventable disease outbreaks. Although at-risk populations in remote areas could benefit from this type of information, they face several logistical barriers to implementation, such as lack of access to centralized laboratories, cold storage, and transport of samples. We describe a potential solution: a compact and portable, field-deployable, point-of-care system relying on digital microfluidics that can rapidly test a small volume of capillary blood for disease-specific antibodies. This system uses inexpensive, inkjet-printed digital microfluidic cartridges together with an integrated instrument to perform enzyme-linked immunosorbent assays (ELISAs). We performed a field validation of the system's analytical performance at Kakuma refugee camp, a remote setting in northwestern Kenya, where we tested children aged 9 to 59 months and caregivers for measles and rubella immunoglobulin G (IgG). The IgG assays were determined to have sensitivities of 86% [95% confidence interval (CI), 79 to 91% (measles)] and 81% [95% CI, 73 to 88% (rubella)] and specificities of 80% [95% CI, 49 to 94% (measles)] and 91% [95% CI, 76 to 97% (rubella)] (measles, n = 140; rubella, n = 135) compared with reference tests (measles IgG and rubella IgG ELISAs from Siemens Enzygnost) conducted in a centralized laboratory. These results demonstrate a potential role for this point-of-care system in global serological surveillance, particularly in remote areas with limited access to centralized laboratories.
Subject(s)
Immunoassay/methods , Microfluidics/methods , Child, Preschool , Enzyme-Linked Immunosorbent Assay , Female , Humans , Immunoglobulin G/blood , Infant , Male , Point-of-Care SystemsABSTRACT
Surveillance of measles virus detected an epidemiologic link between a refugee from Kenya and a Dutch tourist in New Jersey, USA. Identical genotype B3 sequences from patients with contemporaneous cases in the United States, Canada, and Mexico in November and December 2005 indicate that Kenya was likely to have been the common source of virus.
