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Pilot testing of dipsticks as point-of-care assays for rapid diagnosis of poor-quality artemisinin drugs in endemic settings.

Guo S, He L, Tisch DJ, Kazura J, Mharakurwa S, Mahanta J, Herrera S, Wang B, Cui L - Trop Med Health (2016)

Bottom Line: To develop a point-of-care assay for rapid identification of counterfeit and substandard artemisinin drugs for resource-limited areas, we used specific monoclonal antibodies against artesunate and artemether, and developed prototypes of lateral flow dipstick assays.None of the artemether and artesunate drugs collected from public pharmacies in different endemic countries failed the test.It is possible that the simple dipstick assays, with future optimization of test conditions and sensitivity, can be used as a qualitative and semi-quantitative assay for rapid screening of counterfeit artemisinin drugs in endemic settings.

View Article: PubMed Central - PubMed

Affiliation: College of Agronomy and Biotechnology, China Agricultural University, Beijing, China.

ABSTRACT

Background: Good-quality artemisinin drugs are essential for malaria treatment, but increasing prevalence of poor-quality artemisinin drugs in many endemic countries hinders effective management of malaria cases.

Methods: To develop a point-of-care assay for rapid identification of counterfeit and substandard artemisinin drugs for resource-limited areas, we used specific monoclonal antibodies against artesunate and artemether, and developed prototypes of lateral flow dipstick assays. In this pilot test, we evaluated the feasibility of these dipsticks under different endemic settings and their performance in the hands of untrained personnel.

Results: The results showed that the dipstick tests can be successfully performed by different investigators with the included instruction sheet. None of the artemether and artesunate drugs collected from public pharmacies in different endemic countries failed the test.

Conclusion: It is possible that the simple dipstick assays, with future optimization of test conditions and sensitivity, can be used as a qualitative and semi-quantitative assay for rapid screening of counterfeit artemisinin drugs in endemic settings.

No MeSH data available.


Related in: MedlinePlus

Artemether/lumefantrine (20/120) samples tested in PNG showing that all tested drugs passed the tests. Drugs tested include Artefan (1–3 and 5–8), Lumartem (4), Coartem (9 and 10), and Coatal (11). The order of the dipsticks shown here is the same as the order listed in Table 1 for the artemether/lumefantrine drugs tested in PNG
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Fig2: Artemether/lumefantrine (20/120) samples tested in PNG showing that all tested drugs passed the tests. Drugs tested include Artefan (1–3 and 5–8), Lumartem (4), Coartem (9 and 10), and Coatal (11). The order of the dipsticks shown here is the same as the order listed in Table 1 for the artemether/lumefantrine drugs tested in PNG

Mentions: Since the primary goal of this pilot field test was to investigate the performances of the dipsticks as POC devices in endemic settings, we wanted to know the performances of the dipsticks in the hands of different investigators under field conditions. Given the simplicity of the dipstick assay and the familiarity of most malaria-endemic populations with the RDT format, no specific training on the use of the assay was offered. All investigators followed the instructions and successfully performed the dipstick assays under field conditions. After initially dissolving the drug powder in ≥95 % alcohol, the stock solutions were further diluted using regular bottled water. Since the main purpose was to test applicability of the dipsticks in remote endemic settings, rather than to screen counterfeit and substandard drugs, all drugs were purchased from pharmacies in public clinics and hospitals. The test results showed that all tested artemether/lumefantrine, artesunate/pyrimethamine/sulphadoxine, and artesunate injections contained the described amounts of active pharmaceutical ingredients (Fig. 2, Table 1).Fig. 2


Pilot testing of dipsticks as point-of-care assays for rapid diagnosis of poor-quality artemisinin drugs in endemic settings.

Guo S, He L, Tisch DJ, Kazura J, Mharakurwa S, Mahanta J, Herrera S, Wang B, Cui L - Trop Med Health (2016)

Artemether/lumefantrine (20/120) samples tested in PNG showing that all tested drugs passed the tests. Drugs tested include Artefan (1–3 and 5–8), Lumartem (4), Coartem (9 and 10), and Coatal (11). The order of the dipsticks shown here is the same as the order listed in Table 1 for the artemether/lumefantrine drugs tested in PNG
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4940968&req=5

Fig2: Artemether/lumefantrine (20/120) samples tested in PNG showing that all tested drugs passed the tests. Drugs tested include Artefan (1–3 and 5–8), Lumartem (4), Coartem (9 and 10), and Coatal (11). The order of the dipsticks shown here is the same as the order listed in Table 1 for the artemether/lumefantrine drugs tested in PNG
Mentions: Since the primary goal of this pilot field test was to investigate the performances of the dipsticks as POC devices in endemic settings, we wanted to know the performances of the dipsticks in the hands of different investigators under field conditions. Given the simplicity of the dipstick assay and the familiarity of most malaria-endemic populations with the RDT format, no specific training on the use of the assay was offered. All investigators followed the instructions and successfully performed the dipstick assays under field conditions. After initially dissolving the drug powder in ≥95 % alcohol, the stock solutions were further diluted using regular bottled water. Since the main purpose was to test applicability of the dipsticks in remote endemic settings, rather than to screen counterfeit and substandard drugs, all drugs were purchased from pharmacies in public clinics and hospitals. The test results showed that all tested artemether/lumefantrine, artesunate/pyrimethamine/sulphadoxine, and artesunate injections contained the described amounts of active pharmaceutical ingredients (Fig. 2, Table 1).Fig. 2

Bottom Line: To develop a point-of-care assay for rapid identification of counterfeit and substandard artemisinin drugs for resource-limited areas, we used specific monoclonal antibodies against artesunate and artemether, and developed prototypes of lateral flow dipstick assays.None of the artemether and artesunate drugs collected from public pharmacies in different endemic countries failed the test.It is possible that the simple dipstick assays, with future optimization of test conditions and sensitivity, can be used as a qualitative and semi-quantitative assay for rapid screening of counterfeit artemisinin drugs in endemic settings.

View Article: PubMed Central - PubMed

Affiliation: College of Agronomy and Biotechnology, China Agricultural University, Beijing, China.

ABSTRACT

Background: Good-quality artemisinin drugs are essential for malaria treatment, but increasing prevalence of poor-quality artemisinin drugs in many endemic countries hinders effective management of malaria cases.

Methods: To develop a point-of-care assay for rapid identification of counterfeit and substandard artemisinin drugs for resource-limited areas, we used specific monoclonal antibodies against artesunate and artemether, and developed prototypes of lateral flow dipstick assays. In this pilot test, we evaluated the feasibility of these dipsticks under different endemic settings and their performance in the hands of untrained personnel.

Results: The results showed that the dipstick tests can be successfully performed by different investigators with the included instruction sheet. None of the artemether and artesunate drugs collected from public pharmacies in different endemic countries failed the test.

Conclusion: It is possible that the simple dipstick assays, with future optimization of test conditions and sensitivity, can be used as a qualitative and semi-quantitative assay for rapid screening of counterfeit artemisinin drugs in endemic settings.

No MeSH data available.


Related in: MedlinePlus