PrimeStore MTM and OMNIgene Sputum for the Preservation of Sputum for Xpert MTB/RIF Testing in Nigeria

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&ndash
95.4%). Four of 185 culture-negative patients were GX-positive (specificity 97.8%, 94.6&ndash
99.4%). Omnigene GX and Primestore GX were positive in 56/62 (90.3%, 80.1&ndash
96.4%) and 49/62 (79.0%, 66.8&ndash
88.3%) culture-positive, respectively, and 1/185 (99.5%, 97.0&ndash
100.0%) and 3/185 (98.4%, 95.3&ndash
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&ndash
98.2%) and 5/14 (35.7%, 12.8&ndash
64.9%) HIV-infected and 41/44 (93.2%, 81.3&ndash
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.