Фармацевтика Аналитика Акта

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Lifetime Assessment of POCT Strips through Accelerated Degradation Test

Jin-Young Choi, In Mo Yang, Tae-Ho Yoon and Sunmook Lee

In general, single parameter, i.e. temperature, as an accelerating parameter is used to assess the accelerated stability of Point-of-Care Testing (POCT) diagnostic devices. However, humidity also plays an important role in deteriorating the strip performance since major components of test strips are proteins such as enzymes. 5 different Temp/Humi conditions were used to assess the lifetime of strips. Degradation of test strips were studied through the accelerated stability test and the lifetime was assessed using commercial POCT products. The failure time of the test strips was determined to be the time when the concentration at the time of the measurement was out of the range of ± 15% of the initial concentration value, by following the degradation pattern in an exponential fashion. For the combined Temp/Humi accelerated conditions, the lifetime prediction was made by adopting a modified Eyring Eq. Model for Stress-Life relationship, and the B10 lifetime (with CL=90%) was estimated to be 505 h (lower limit) when Weibull distribution was applied as the lifetime distribution of strips.