期刊
JOURNAL OF CLINICAL MEDICINE
卷 8, 期 12, 页码 -出版社
MDPI
DOI: 10.3390/jcm8122146
关键词
tuberculosis; diagnosis; OMNIGene-sputum; PrimeStore; Xpert MTB/RIF
资金
- European and Developing Countries Clinical Trial Partnership (EDCTP) [DRIA2014-309]
- Medical Research Council (MRC), UK
- Instituto de Salud Carlos III (ISCIII Spain)
- Global Affairs Canada, through the TB REACH Initiative of the Stop TB Partnership, Wave 5, project [STBP/TBREACH//GSA/W5-07]
Background: Xpert MTB/RIF (GX) for tuberculosis (TB) diagnosis is often located in reference laboratories, and sputum needs to be transported using a cold chain. Transport media to preserve sputum are available, but performance data under programmatic conditions are limited. Methods: Sputum samples were collected from patients with presumptive TB in Nigeria. One sputum was transported in a cold chain, tested immediately with GX and cultured. One sputum was swabbed and stored in PrimeStore-Molecular-Transport-Medium (Primestore), and the remainder was stored in OMNIGene-sputum (Omnigene), kept for seven days and tested with GX. Results: Of 248 patients, 63 were fresh-sputum culture-positive and 56 GX-positive (sensitivity 88.9%, 95% CI: 78.4-95.4%). Four of 185 culture-negative patients were GX-positive (specificity 97.8%, 94.6-99.4%). Omnigene GX and Primestore GX were positive in 56/62 (90.3%, 80.1-96.4%) and 49/62 (79.0%, 66.8-88.3%) culture-positive, respectively, and 1/185 (99.5%, 97.0-100.0%) and 3/185 (98.4%, 95.3-99.7%) were culture-negative patients. 14 Human Immunodeficiency Virus (HIV)-infected and 44 HIV-uninfected patients were culture-positive. Omnigene and Primestore detected 12/14 (85.7%, 57.2-98.2%) and 5/14 (35.7%, 12.8-64.9%) HIV-infected and 41/44 (93.2%, 81.3-98.6%) HIV-uninfected culture-positive patients. Interpretation: Omnigene stored and fresh sputum samples had similar GX results. The GX results of Primestore-stored samples were similar to those found in the fresh sputum of non-HIV infected patients, but GX-positivity was lower in HIV-infected patients. This was likely due to the lower amount of bacilli collected by the swab and transferred to PrimeStore.
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