国产全自动血培养系统及配套血培养瓶性能评估

Performance Evaluation of Domestic LABSTAR120 Automated Blood Culture System and Its Blood Culture Bottles

目的通过与美国BD BACTEC FX200全自动血培养系统的比较,对国产LABSTAR全自动血培养系统进行性能评估。方法两种血培养系统分别使用标准菌株模拟样本和临床样本,分别对需养瓶和厌氧瓶进行评估。将标准菌株和疑似血流感染的临床样本按要求分别注入两种产品配套血培养瓶内进行培养,对比评估国产LABSTAR与对照产品结果的一致率,及阳性结果报警的时间差异。结果模拟样本评估结果:需氧瓶组评估23例模拟样本,两个血培养系统全部报阳,阳性报警时间无统计学差异。厌氧瓶组评估14例模拟样本,同时报阳的11例报警有统计学差异。临床样本评估结果:需氧瓶组531例,25例报阳结果相同,报警时间有统计学差异,培养结果总体一致率为96.4%;厌氧瓶组361例,8例报阳结果相同,报警时间有统计学差异,培养结果总体一致率为95.8%。结论国产LABSTAR全自动血培养系统与对照美国BD BACTEC FX200全自动血培养系统培养结果一致率高,但阳性结果报警时间偏长。

Objective To evaluated the performance of domestic LABSTAR automatic blood culture system comparison with BD BACTEC FX200 automatic blood culture system. Methods Two blood culture systems were used to simulate the specimens and clinical specimens in two parts, each of which was evaluated by a bottle and an anaerobic bottle. The standard strains and suspected or confirmed blood flow of clinical specimens were injected into their respective matching blood culture bottles were cultured, the comparative evaluation of domestic LABSTAR and the BD BACTEC FX200 results consistent rate,and positive results of the alarm time difference. Results Simulated specimens were evaluated： 23 cases of simulated specimens were evaluated by aerobic bottle group. All the two blood culture systems were reported positive and no significant difference was found between the two groups. Anaerobic bottle group to assess 14 cases of simulated samples, while the sun reported 11 cases were statistically significant difference. The results of clinical specimens：531 cases of oxygen bottles, 245 cases of sun and the same results, the alarm time was statistically significant, the overall consistency rate of 96.4% . An aerobic bottle group 361 cases, 8 cases of sun and the results were the same, the alarm time was statistically different, and the overall consistency rate was 95.8%. Conclusion The coincidence rate of Domestic LABSTAR automatic blood culture system and BD BACTEC FX200 automatic blood culture system was high, but the time of positive alarm time more long.