| Description |
Rheumatic fever and rheumatic heart disease have been on the decline in the last century, but several episodes of resurgence in the United States and Europe, as well as continued high mortality in developing countries, reinforce the need for continued development of improved methods for detection of the causative agent, Group A Strep pharyngitis. Traditionally diagnosed via clinical and bacteriologic methods, newer molecular strategies to identify Group A Strep in patient samples have become available, but their acceptance for clinical testing has been thwarted by test complexity, expense, and lack of timeliness. With the advent of LAMP molecular technology, simpler molecular tests more appropriate for rapid, inexpensive diagnostic assays are becoming available. A comparison of one of these assays, illumigene® Group A Streptococcus DNA Amplification Assay, with traditional rapid antigen and culture testing from the perspective of sensitivity, specificity, accuracy, convenience and ease of use, time constraints, "real" value, process improvement, and cost was undertaken. illumigene® outperformed combined antigen and culture testing in sensitivity, accuracy, and turnaround time. Both methodologies were very similar for specificity and perceived test convenience. In a data review from the perspective of diagnostic accuracy, illumigene® was 99.5% accurate compared to combined accuracy rate of 93.2% for antigen and culture testing, indicating that one case would have been misdiagnosed by illumigene® compared to 36 cases being misdiagnosed or treatment delayed using traditional testing iv methods. Three different approaches to cost comparison yielded equivocal results that cannot be resolved without further real-world study, but illumigene® outperformed routine antigen and culture testing in two of three cost scenarios. Based on the data obtained in this study, illumigene® has proven to be a viable contender for inclusion in future algorithms for improved diagnosis of Group A Strep pharyngitis, and its use will mitigate the damaging effects of this disease and its sequelae. |
