Antibiotic Analysis Using Paper Test Cards for the Improvement of Global Health

Location: Kenya

Alumni: Jalen Carpenter

Faculty: Marya Lieberman

The mass distribution of substandard pharmaceuticals is considered a world-wide phenomenon and is documented as most severe in low-income countries.  The countries that are in need of sophisticated analytical power for pharmaceutical testing are usually incapable of affording the methods.  The need for a less expensive, more efficient testing method is needed.  The method of iodometric back-titration has been translated onto paper test cards in order to meet the need for such a method. The test card underwent a blind validation study using 22 amoxicillin samples from Kenya.  Precision and percent error were calculated at 2 percent.  To gain more robust data and continue research, another blind validation study was conducted in the Lieberman Lab at University of Notre Dame. 32 amoxicillin samples sent from Kenya were chosen for the study.  The samples went through a thermal degradation process to mimic substandard pharmaceuticals and were re-assayed via HPLC analysis.  The HPLC results were blinded until after results for the 32 samples were assessed using the paper test cards.  Results indicated that 25 out of the 32 samples tested were analyzed correctly by the paper test cards.  Results from a preivous blind internal validation study of amoxicillin samples from Kenya were included in the final analysis to produce more robust results.  Sensitivity and specificity were calculated at 100% and 82%, respectively.  Cohen’s kappa was calculated at 70 percent, indicating substantial level of agreement between the paper test card method and the HPLC method.  With continued improvement and usability testing in the field, the paper test card can become the go-to method for in-field assaying of beta-lactam pharmaceuticals.  Through further study with larger pharmaceutical sample sizes, the card can eventually be proven a trustworthy method of pharmaceutical screening throughout different sectors of the pharmaceutical chain supply. 

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