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印度医学微生物学协会外部质量保证计划中心(新德里)的经验:临床微生物学实验室面临的挑战与质量评估

Experience of Indian association of medical microbiology external quality assurance scheme centre, New Delhi: Challenges and quality assessment of clinical microbiology laboratories.

作者信息

Wattal Chand, Oberoi Jaswinder Kaur, Goel Neeraj, Datta Sanghamitra, Raveendran Reena, Prasad K J

机构信息

Department of Clinical Microbiology, Sir Ganga Ram Hospital, New Delhi, India.

出版信息

Indian J Med Microbiol. 2019 Apr-Jun;37(2):163-172. doi: 10.4103/ijmm.IJMM_19_356.

Abstract

INTRODUCTION

EQAS program at New Delhi under IAMM was started in January 2014 across North and North east regions of India with 217 participants, which grew up to 540 by 2018.

MATERIALS AND METHODS

In 2014, 4 analytes per year were sent for 3 exercises, i.e. smear culture and serology. 2018 onwards PT analytes were increased from 4 to 12 and comparative performance of techniques analysed.

RESULTS

Out of the 22 smears sent for gram staining, ZN staining, Kinyoun staining and Albert staining, completely correct results ranged between 29.55% - 79.9%, 94.3% - 99.2%, 35.5% & 93.8%, respectively. Correct results for culture isolate identification & susceptibility testing and serology exercises varied between 70 & 92.4% and 73.1 & 98.59%, respectively. In the year 2018, 470 responses were received for bacterial culture identification & antibiotic susceptibility testing out of which manual and automated systems were used by 54% & 46% and 52.5% & 47.5% participants, respectively. Techniques used in BBV assays for HBsAg, HCV & HIV found all methods like ELISA, ELFA, CLIA and Card Test performing similarly. The major challenges in running the EQA program included requirement of large amount of specimens for PT item preparation, stability in hot and humid conditions and timely delivery of PT challenges in remote parts of the country.

CONCLUSION

A large number of the participating laboratories (77%) had an overall score of >80% for all exercises, demonstrating acceptable baseline performance of EQAS registered laboratories. However, continued EQAS participation could further improve the quality of results.

摘要

引言

新德里的国际医学微生物学会(IAMM)外部质量评估计划(EQAS)于2014年1月在印度北部和东北部地区启动,当时有217名参与者,到2018年增加到540名。

材料与方法

2014年,每年有4种分析物用于3项检测,即涂片培养和血清学检测。从2018年起,能力验证(PT)分析物从4种增加到12种,并对技术的比较性能进行了分析。

结果

在送去进行革兰氏染色、抗酸染色、金扬染色和阿尔伯特染色的22份涂片中,完全正确的结果分别在29.55% - 79.9%、94.3% - 99.2%、35.5%和93.8%之间。培养物分离鉴定及药敏试验和血清学检测的正确结果分别在70%至92.4%和73.1%至98.59%之间。2018年,收到了470份细菌培养鉴定及抗生素药敏试验的回复,其中分别有54%和46%的参与者使用了手动和自动化系统,在乙肝病毒(HBV)、丙肝病毒(HCV)和艾滋病毒(HIV)检测的酶联免疫吸附测定(ELISA)中发现所有方法,如酶联荧光免疫分析(ELFA)、化学发光免疫分析(CLIA)和快速检测卡,表现相似。开展EQAS计划的主要挑战包括制备PT项目需要大量标本、在炎热潮湿条件下的稳定性以及在该国偏远地区及时提供PT挑战。

结论

大量参与实验室(77%)在所有检测中的总体得分>80%,表明EQAS注册实验室的基线表现可接受。然而,持续参与EQAS可以进一步提高结果质量。

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