The development of an efficient and reliable specimen referral system still represents a major challenge and cost burden for many TB programs worldwide. This requires the appropriate storage of the specimens at the collection site and their rapid transportation to the testing facility in temperature controlled conditions. Overall, OM-S offers multiple benefits both at laboratory and TB national program level by increasing the availability to quality diagnostics, promoting access to health care services and strengthening TB patient care especially in hard to reach populations.Дespite great advances in tuberculosis (TB) diagnostics, a point of care testing for TB is yet not available and most of the procedures currently endorsed by the World Health Organization (WHO) including culture, phenotypic drug susceptibility testing (DST) and line probe assays (LPAs) are intended to be performed in higher level facilities and reference laboratories. However, a significant delay in the time to culture positivity was observed for samples stored for more than two weeks in OM-S. Our data show thatВ OM-S maintains MTB viability for at least three weeks in the absence of refrigeration and improves the quality of culture resulting in a contamination rate lower than 0.5%. Samples in OM-S were shipped to the Supranational Reference Laboratory in Milan, Italy, at various times and processed for liquid culture. A total of 329 sputum specimens from presumptive TB cases collected at the National Reference Laboratory in Tirana, Albania, were either decontaminated by a conventional method or processed with OM-S reagent and stored at room temperature. We evaluated the performance of OMNIgene-SPUTUM (OM-S) reagent for the maintenance of Mycobacterium tuberculosis (MTB) viability in sputum samples in the absence of refrigeration and its capacity to stabilize nucleic acid for molecular testing. The development of transport media allowing the preservation of samples without refrigeration is critical for increasing access to TB diagnostic services and for reducing the costs related to testing. Sample referral systems in low and middle income countries are often weak and the maintenance of the cold-chain challenging and very costly for TB programs. Maintaining the quality of clinical specimens for tuberculosis (TB) testing is a major challenge in many high TB burden-limited resources countries.

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