Analytical and Clinical Validation of Six Commercial Middle East Respiratory Syndrome Coronavirus RNA Detection Kits Based on Real-Time Reverse-Transcription PCR

Kim, Mi-Na; Ko, Young Jin; Seong, Moon-Woo; Kim, Jae-Seok; Shin, Bo-Moon; Sung, Heungsup

The clinical sensitivities of the kits were all 100% (Table 2) . Because the sensitivity test panel comprised various positive specimens with a wide range of Ct values, this high sensitivity validated their diagnostic performance for MERS-CoV infection, particularly from sputum specimens, although the number of positive specimens was small. One of the strengths in the present study was determining the effects of PCR inhibition on clinical sensitivity and the importance of internal controls (Table 3) . The internal controls of the PowerChek kit were not affected by the inhibition. This could be because the PowerChek kit uses a less sensitive internal control that is intrinsic to human cells, although the PCR efficiency of this kit itself was also less affected.