SMALL SAMPLE SIZE CAPABILITY INDEX FOR ASSESSING VALIDITY OF ANALYTICAL METHODS

peer reviewedaudience: researcher, professional, studentAnalytical method’s capability evaluation can be a useful methodology to assess the fitness of purpose of these methods for their future routine application. However, care on how to compute the capability indices has to be made. Indeed, the commonly used formulas to compute capability indices such as Cpk, will highly overestimate the true capability of the methods. Especially during methods validation or transfer, there are only few experiments performed and, using in these situations the commonly applied capability indices to declare a method as valid or as transferable to a receiving laboratory will conduct to inadequate decisions. In this work, an improved capability index, namely Cpk-tol and the corresponding estimator of proportion of non conforming results (tolCpk−π) is proposed. Through Monte-Carlo simulations, they have been shown to greatly increase the estimation of analytical methods capability in particular in low sample size situations as encountered during methods validation or transfer. Additionally, the usefulness of this capability index is illustrated through several case studies

Separation of aminoglutethimide enantiomers using single and dual cyclodextrin system in capillary electrophoresis

peer reviewedaudience: researcher, professional, student, popularizatio

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Interest of Raman spectroscopy for the detection and analysis of poor-quality medicines

editorial reviewedAccess to quality medicines is an essential right of the patients. However, in 2017, the World Health Organization estimated that 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified. This reinforces the fact that post-marketing surveillance (PMS) of medical products by strong national regulatory authorities (NRA) is crucial. To achieve an efficient PMS, the NRA need analytical tools at the inspection, screening, confirmatory and forensics levels to control the physicochemical properties of the samples. Among the analytical tools available, Raman spectroscopy is particularly interesting because of its spectral specificity and the wide variety of acquisition modes available. Handheld devices may be used directly on the field to confirm the presence of a specific active pharmaceutical ingredient (API) in a formulation [1]. Thanks to databases of pure ingredients, it is also possible to identify the compound present when a wrong API is present [2]. Recent developments have extended the applicability of handheld devices to the analysis of fluorescent chemicals and the analysis through barriers [3]. The detection of substandard medicines is also made possible with the construction of regression chemometrics models [4]. Benchtop systems and among them imaging systems are particularly useful in the confirmatory and forensic steps. Indeed, the imaging systems enable the visualization and identification of a large range of both organic and inorganic compounds used as API or excipients [5]. In addition, thanks to the high spatial resolution, it allows the detection of trace contaminants. This information may be of particular interest during prosecutions and the clustering of criminal cases. Nevertheless, the extraction of the relevant information from the raw measurements requires once again intensive work by highly trained staff. In conclusion, Raman spectroscopy have particularly interesting features for the PMS of medicines

Altas capacidades: luces y sombras

Poor-quality medicines are a threat to public health in many low- and middle-income countries, and prospective surveys are needed to inform corrective actions. Therefore, we conducted a cross-sectional survey on a sample of products used for children and available in the private market in Kinshasa, Democratic Republic Congo: amoxicillin (AX) and artemether/lumefantrine (AL), powders for suspension, and paracetamol (PC) tablets 500 mg. Overall, 417 products were covertly purchased from 61 wholesalers. To obtain a representative sample, the products were weighted on their market shares and a subset of 239 samples was randomly extracted to undergo in-depth visual inspection locally, and they were chemically assessed at two accredited laboratories in Belgium. Samples were defined of “poor-quality” if they failed to comply with at least one specification of the International Pharmacopoeia (for AL) or United States Pharmacopoeia 37 (for AX and PC). Results are reported according to the Medicine Quality Assessment Reporting Guideline. The visual inspection detected nonconformities in the aspects of antimalarial powders for suspension, and poor-quality labels across all medicine types. According to chemical analysis, 27.2% samples were of poor quality and 59.5% of AL samples were underdosed in artemether. Poor quality was more frequent for locally manufactured antimalarials (83.3%, P = 0.021; 86.4%, P = 0.022) and PC (4.8%, P = 0.000). The poor quality of the surveyed products may decrease the treatment’s efficacy and favor the development of resistances to antimalarials. It is hoped that these findings may guide the corrective actions of the Democratic Republic of Congo Regulatory Authority, which was the main partner in the research

Auto-test sur sang prélevé au bout du doigt pour la détection d'HIV, HBV et HCV utilisant un test immunochromatographique multiplex: étude pilote en Afrique subsaharienne

peer reviewedBACKGROUND: The burden of HIV, HBV, and HCV infections remains disproportionately high in sub-Saharan Africa, with high rates of co-infections. Multiplex rapid diagnostic tests for HIV, HBV and HCV serological testing with high analytical performances may improve the "cascade of screening" and quite possibly the linkage-to-care with reduced cost. Based on our previous field experience of HIV self-testing, we herein aimed at evaluating the practicability and acceptability of a prototype finger-stick whole-blood Triplex HIV/HCV/HBsAg self-test as a simultaneous serological screening tool for HIV, HBV, and HCV in the Democratic Republic of the Congo (DRC). METHODS: A cross-sectional multicentric study consisting of face-to-face, paper-based, and semi-structured questionnaires with a home-based and facility-based recruitment of untrained adult volunteers at risk of HIV, HBV, and HCV infections recruited from the general public was conducted in 2020 in urban and rural areas in the DRC. The practicability of the Triplex self-test was assessed by 3 substudies on the observation of self-test manipulation including the understanding of the instructions for use (IFU), on the interpretation of Triplex self-test results and on its acceptability. RESULTS: A total of 251 volunteers (mean age, 28 years; range, 18-49; 154 males) were included, from urban [160 (63.7%)] and rural [91 (36.3%)] areas. Overall, 242 (96.4%) participants performed the Triplex self-test and succeeded in obtaining a valid test result with an overall usability index of 89.2%. The correct use of the Triplex self-test was higher in urban areas than rural areas (51.2% versus 16.5%; aOR: 6.9). The use of video IFU in addition to paper-based IFU increased the correct manipulation and interpretation of the Triplex self-test. A total of 197 (78.5%) participants correctly interpreted the Triplex self-test results, whereas 54 (21.5%) misinterpreted their results, mainly the positive test results harboring low-intensity band (30/251; 12.0%), and preferentially the HBsAg band (12/44; 27.3%). The rates of acceptability of reuse, distribution of the Triplex self-test to third parties (partner, friend, or family member), linkage to the health care facility for confirmation of results and treatment, and confidence in the self-test results were very high, especially among participants from urban areas. CONCLUSIONS: This pilot study shows evidence for the first time in sub-Saharan Africa on good practicability and high acceptability of a prototype Triplex HIV/HCV/HBsAg self-test for simultaneous diagnosis of three highly prevalent chronic viral infections, providing the rational basis of using self-test harboring four bands of interest, i.e. the control, HIV, HCV, and HBsAg bands. The relatively frequent misinterpretation of the Triplex self-test points however the necessity to improve the delivery of this prototype Triplex self-test probably in a supervised setting. Finally, these observations lay the foundations for the potential large-scale use of the Triplex self-test in populations living in sub-Saharan Africa at high risk for HIV, HBV, and HCV infections

Applications of vibrational spectroscopy and hyperspectral imaging for the analysis of substandard and falsified medicines.

peer reviewedAccess to quality medicines is an essential right of the patients. However, in 2017, the World Health Organization estimated that 1 in 10 medical products circulating in low- and middle-income countries is either substandard or falsified. This reinforces the fact that post-marketing surveillance (PMS) of medical products by strong national regulatory authorities (NRA) is crucial. To achieve an efficient PMS, the NRA need analytical tools at the inspection, screening, confirmatory and forensics levels to control the physicochemical properties of the samples. Because of their fast, non-destructive, and relatively affordable character, vibrational spectroscopy tools are unavoidably present at each step. Handheld devices are particularly useful during inspection and screening phases since these tools can identify and/or quantify active pharmaceutical ingredients (API) even through opaque packaging in seconds. However, they generally need exhaustive and up-to-date databases for each specific product. Another limitation is the work and time needed before going into the field to develop and validate the chemometric models. Indeed, this mandatory step requires highly skilled scientists and a prior collection of certified references of the medicines to analyse. Benchtop systems and among them imaging systems are particularly useful in the confirmatory and forensic steps. Indeed, the imaging systems enable the visualization and identification of a large range of both organic and inorganic compounds used as API or excipients. In addition, thanks to the high spatial resolution, it allows the detection of trace contaminants. This information may be of particular interest during prosecutions and the clustering of criminal cases. Nevertheless, the extraction of the relevant information from the raw measurements requires once again intensive work by highly trained staff. In conclusion, vibrational spectroscopy tools have particularly interesting features for the PMS of medicines, but research is still needed to make them easier to set up and use by NRA inspectors and non-specialists