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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

a The assembled dipsticks for analysis of artesunate/artemether-containing drugs. The disappearance of the test line indicates that concentration of the tested drug is above the limit of detection of the dipstick. b Description of the test results according to the instruction sheet. Concentration at LOD (limit of detection) shows the potential results of the tested drug when diluted to the LOD based on the described drug content
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Fig1: a The assembled dipsticks for analysis of artesunate/artemether-containing drugs. The disappearance of the test line indicates that concentration of the tested drug is above the limit of detection of the dipstick. b Description of the test results according to the instruction sheet. Concentration at LOD (limit of detection) shows the potential results of the tested drug when diluted to the LOD based on the described drug content

Mentions: We have developed a dipstick that can be used as a POC test for artemisinin-, artesunate-, and dihydroartemisinin-containing drugs using a mAb (3D82G7) that has considerable cross-reactivities to these three compounds [12]. To differentiate artemisinin and its derivatives in different ACT drugs, we developed a dipstick using a mAb (3D82G6) that is specific for artesunate [13]. Recently, based on a mAb (2G12E1) that is specific for artemether [10], we developed a dipstick specifically for detecting artemether in ACT drugs (described elsewhere). Here, we used mAb 2G12E1 and mAb 3D82G6 to prepare two types of dipsticks that are specific for artemether and artesunate, respectively. Preparation of colloidal gold-conjugated antibodies and assembly of the dipsticks were performed as described earlier [12]. The sensitivities of these batches of dipsticks (indicator ranges) were determined using serially diluted artemether and artesunate, respectively [12]. The final dipsticks (Fig. 1a) were then sealed in a plastic case with desiccant gel and, together with the instruction sheet, sent to different laboratories for evaluation.Fig. 1


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)

a The assembled dipsticks for analysis of artesunate/artemether-containing drugs. The disappearance of the test line indicates that concentration of the tested drug is above the limit of detection of the dipstick. b Description of the test results according to the instruction sheet. Concentration at LOD (limit of detection) shows the potential results of the tested drug when diluted to the LOD based on the described drug content
© Copyright Policy - OpenAccess
Related In: Results  -  Collection

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

Fig1: a The assembled dipsticks for analysis of artesunate/artemether-containing drugs. The disappearance of the test line indicates that concentration of the tested drug is above the limit of detection of the dipstick. b Description of the test results according to the instruction sheet. Concentration at LOD (limit of detection) shows the potential results of the tested drug when diluted to the LOD based on the described drug content
Mentions: We have developed a dipstick that can be used as a POC test for artemisinin-, artesunate-, and dihydroartemisinin-containing drugs using a mAb (3D82G7) that has considerable cross-reactivities to these three compounds [12]. To differentiate artemisinin and its derivatives in different ACT drugs, we developed a dipstick using a mAb (3D82G6) that is specific for artesunate [13]. Recently, based on a mAb (2G12E1) that is specific for artemether [10], we developed a dipstick specifically for detecting artemether in ACT drugs (described elsewhere). Here, we used mAb 2G12E1 and mAb 3D82G6 to prepare two types of dipsticks that are specific for artemether and artesunate, respectively. Preparation of colloidal gold-conjugated antibodies and assembly of the dipsticks were performed as described earlier [12]. The sensitivities of these batches of dipsticks (indicator ranges) were determined using serially diluted artemether and artesunate, respectively [12]. The final dipsticks (Fig. 1a) were then sealed in a plastic case with desiccant gel and, together with the instruction sheet, sent to different laboratories for evaluation.Fig. 1

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