A novel strategy for interpreting the T-SPOT.TB test results read by an ELISPOT plate imager


Autoři: Tae Yeul Kim aff001;  Ho Eun Chang aff001;  Seong-Wook Lee aff002;  Soo Hyun Seo aff001;  Yun Ji Hong aff001;  Jeong Su Park aff001;  Kyoung Un Park aff001
Působiště autorů: Department of Laboratory Medicine, Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-do, Korea aff001;  Department of Molecular Biology, Dankook University, Yongin-si, Gyeonggi-do, Korea aff002;  Department of Laboratory Medicine, Seoul National University College of Medicine, Seoul, Korea aff003
Vyšlo v časopise: PLoS ONE 14(9)
Kategorie: Research Article
doi: 10.1371/journal.pone.0222920

Souhrn

Background

The T-SPOT.TB can be read by an ELISPOT plate imager as an alternative to a labor-intensive and time-consuming manual reading, but its accuracy has not been sufficiently discussed to date.

Methods

1,423 test results obtained from manual reading using a microscope and an ELISPOT plate imager were compared. The agreement of qualitative test results was assessed using Cohen's kappa coefficient. The relationship of spot counts was studied using Bland-Altman analysis.

Results

The overall percent agreement of the qualitative test results was 95.43% with a kappa coefficient of 0.91. Positive test results with the maximum net spot count of 8 and borderline test results showed relatively high discordance. The agreement of spot counts in panel A, panel B, and nil control was good, and variability did not increase with higher spot counts. On the basis of study findings, a novel strategy for interpreting the test results by an ELISPOT plate imager was proposed.

Conclusions

To increase diagnostic accuracy, positive test results with the maximum net spot count of 8 and borderline test results should be manually confirmed. Our strategy could be a practical guide for laboratories to build their own strategies for interpreting the test results by an ELISPOT plate imager.

Klíčová slova:

Decision making – Enzyme-linked immunoassays – Granulocytes – Nontuberculous mycobacteria – Qualitative studies – T cells – Technicians – Tuberculosis


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PLOS One


2019 Číslo 9

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