Xpert MTB/RIF was first introduced in 2012 followed by LPAs for first-line drugs in 2012 and LPAs for second-line drugs in 2016. To keep abreast of this public health threat, the National TB Program (NTP) has introduced and deployed new molecular diagnostic tests (Xpert MTB/RIF and LPAs) in the laboratories to complement sputum smear microscopy and phenotypic CDST. The country is regarded as one of thirty countries in the world with the highest MDR-TB burden. In spite of this progress, the country has a large problem with drug resistance with a prevalence of MDR-TB of 23% (range 18–29%) in new patients and 62% (range 52–71%) in previously treated patients reported from a drug resistance survey in 2010–2011. Uzbekistan, in central Asia, has seen a significant decline in the number of reported TB patients over the last 16 years from 94 per 100,000 people in 2003 to 49 per 100,000 in 2019, respectively.

LPAs use nucleic acid amplification and gene mutation detection and are recommended by the WHO as the initial diagnostic test for detecting drug resistance to rifampicin and isoniazid and for detecting an additional resistance to second-line drugs if a prior diagnosis of rifampicin-resistant TB or MDR-TB is made. Line probe assays (LPAs) (Hain LifeScience GmbH, Nehren, Germany) are an alternative and much faster molecular diagnostic method taking between two to three days for results in good functioning and well-resourced laboratories. However, the major disadvantage of this method is that CDST results can take several weeks during which time patients may be lost to follow-up and continue to transmit infection within the family and the community. For this, mycobacterial culture and phenotypic drug susceptibility testing (CDST) using solid or liquid culture media has traditionally been used. The standard Xpert MTB/RIF assay, however, cannot diagnose other forms of drug resistance. MDR-TB and XDR-TB treatment includes both short and long treatment regimens with second-line drugs such as kanamycin, levofloxacin, clofazamine, bedaquiline, cycloserine and prothionamide. The treatment for drug-susceptible TB is with a six-month regimen of rifampicin and isoniazid supplemented with pyrazinamide and ethambutol for the first two months. Rifampicin-resistant TB (RR-TB) as detected by Xpert MTB/RIF assays is regarded as a proxy for MDR-TB and patients with RR-TB are treated with MDR-TB treatment regimens. Using a culture as the reference standard, it has a high sensitivity and specificity and the assay was recommended by the WHO from 2013 as the initial diagnostic test for all people needing investigation for TB. Programmatic implications and ways forward are discussed.Ī “game changer” in the diagnosis of TB has been the introduction, deployment and scale-up of the Xpert MTB/RIF assay (Cepheid Inc., Sunnyvale, CA, USA), a fully automated, commercial nucleic acid amplification test that allows the simultaneous diagnosis of MTB and detection of rifampicin resistance within two hours. Patient numbers with laboratory-confirmed MDR-TB remained stable (from 1728 to 2060) but there was a large increase in patients with laboratory-confirmed XDR-TB (from 31 to 696). LPA instruments cumulatively increased from two to thirteen the annual first-line assays for MDR-TB increased from 2582 to 6607 while second-line assays increased from 1435 in 2016 to 6815 in 2019 with about one quarter to one third of diagnosed patients showing second-line drug resistance. A broader use of the technology resulted in a lower proportion of tests detecting Mycobacterium tuberculosis with half of the positive results showing rifampicin resistance.

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The numbers of GeneXpert instruments cumulatively increased from six to sixty-seven, resulting in annual assays increasing from 5574 to 107,330. This was a descriptive study using secondary program data. We documented the scale-up of Xpert and LPAs from 2012–2019 and assessed whether this led to an increase in patients with laboratory-confirmed multidrug-resistant/rifampicin-resistant TB (MDR/RR-TB) and extensively drug-resistant TB (XDR-TB). To deal with this public health threat, the National TB Program introduced rapid molecular diagnostic tests such as Xpert MTB/RIF (Xpert) and line probe assays (LPAs) for first-line and second-line drugs. Uzbekistan has a large burden of drug-resistant tuberculosis (TB).

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