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Guidelines on the Prevention and Control of Tuberculosis in Ireland

Guidelines on the Prevention and Control of Tuberculosis in Ireland

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<str<strong>on</strong>g>Guidel<strong>in</strong>es</str<strong>on</strong>g> <strong>on</strong> <strong>the</strong> Preventi<strong>on</strong> <strong>and</strong> C<strong>on</strong>trol <strong>of</strong> <strong>Tuberculosis</strong> <strong>in</strong> Irel<strong>and</strong> 2010HSE/HPSC4. Laboratory Diagnosis <strong>of</strong> <strong>Tuberculosis</strong>4.1 Role <strong>and</strong> Goals <strong>of</strong> <strong>the</strong> Modern TB LaboratoryThe microbiology laboratory makes a key c<strong>on</strong>tributi<strong>on</strong> to TB c<strong>on</strong>trol <strong>in</strong> terms <strong>of</strong> diagnosis, <strong>in</strong>fecti<strong>on</strong>preventi<strong>on</strong> <strong>and</strong> c<strong>on</strong>trol <strong>and</strong> management <strong>of</strong> <strong>the</strong> disease. The detecti<strong>on</strong> <strong>and</strong> isolati<strong>on</strong> <strong>of</strong> mycobacteria,identificati<strong>on</strong> <strong>of</strong> <strong>the</strong> mycobacterial species or complex isolated <strong>and</strong> <strong>the</strong> determ<strong>in</strong>ati<strong>on</strong> <strong>of</strong> susceptibilities <strong>of</strong><strong>the</strong> organism to anti-mycobacterial drugs are key functi<strong>on</strong>s <strong>of</strong> a modern TB laboratory. 110 The gold st<strong>and</strong>ardfor diagnos<strong>in</strong>g active disease is by microbiological identificati<strong>on</strong> <strong>of</strong> TB by culture. Molecular typ<strong>in</strong>g <strong>of</strong>isolates c<strong>on</strong>tributes significantly to underst<strong>and</strong><strong>in</strong>g <strong>the</strong> epidemiology <strong>of</strong> TB. Populati<strong>on</strong> based molecularepidemiology studies have been used to evaluate TB c<strong>on</strong>trol efforts, provid<strong>in</strong>g <strong>in</strong>sights <strong>in</strong>to transmissi<strong>on</strong>dynamics, enhanc<strong>in</strong>g c<strong>on</strong>tact trac<strong>in</strong>g <strong>and</strong> aid<strong>in</strong>g <strong>the</strong> detecti<strong>on</strong> <strong>of</strong> laboratory cross-c<strong>on</strong>tam<strong>in</strong>ati<strong>on</strong>. 111 Therole <strong>and</strong> importance <strong>of</strong> skilled <strong>and</strong> experienced staff cannot be over emphasised. 112In 1993, WHO declared TB a global emergency <strong>in</strong> resp<strong>on</strong>se to an <strong>in</strong>crease <strong>in</strong> cases after nearly a century <strong>of</strong>decl<strong>in</strong>e. Targets for achiev<strong>in</strong>g improved c<strong>on</strong>trol were developed which <strong>in</strong>volved diagnos<strong>in</strong>g a m<strong>in</strong>imum <strong>of</strong>70% <strong>of</strong> <strong>in</strong>dividuals with sputum smear positive TB <strong>and</strong> cur<strong>in</strong>g at least 85%. In Irel<strong>and</strong>, important legislativechanges have occurred s<strong>in</strong>ce <strong>the</strong> publicati<strong>on</strong> <strong>of</strong> <strong>the</strong> 1996 TB guidel<strong>in</strong>es. 113 In 2003, <strong>the</strong> Infectious DiseasesRegulati<strong>on</strong>s 1981 were amended by <strong>the</strong> Infectious Disease (Amendment) (No. 3) Regulati<strong>on</strong>s 2003 (S.I.No. 707 <strong>of</strong> 2003), stat<strong>in</strong>g that a cl<strong>in</strong>ical director <strong>of</strong> a diagnostic laboratory shall have regard to <strong>the</strong> casedef<strong>in</strong>iti<strong>on</strong>s for notificati<strong>on</strong> <strong>of</strong> <strong>in</strong>fectious diseases. 21 The DPH or designated medical <strong>of</strong>ficer should benotified <strong>of</strong> <strong>the</strong> identificati<strong>on</strong> <strong>of</strong> a TB case ideally with<strong>in</strong> <strong>on</strong>e work<strong>in</strong>g day.Recommendati<strong>on</strong>:It is a m<strong>and</strong>atory requirement for cl<strong>in</strong>ical directors <strong>of</strong> diagnostic laboratories to notify cases <strong>of</strong>active TB disease to <strong>the</strong> medical <strong>of</strong>ficer <strong>of</strong> health (director <strong>of</strong> public health or designate).Culture is necessary to achieve <strong>the</strong> “gold st<strong>and</strong>ard” for <strong>the</strong> diagnosis <strong>of</strong> active tuberculosisdisease.Levels <strong>of</strong> serviceBefore <strong>of</strong>fer<strong>in</strong>g mycobacteriology services, each laboratory should assess <strong>the</strong> capacity <strong>and</strong> capability <strong>of</strong> <strong>the</strong>level <strong>of</strong> services performed. Cl<strong>in</strong>ical laboratories <strong>of</strong>fer<strong>in</strong>g a mycobacteriology service are divided <strong>in</strong>to threemajor categories <strong>of</strong> service (table 4.1). This follows recommendati<strong>on</strong>s by CDC <strong>and</strong> <strong>the</strong> American ThoracicSociety (ATS) stat<strong>in</strong>g that laboratories <strong>in</strong>terpret<strong>in</strong>g acid fast sta<strong>in</strong>ed smears should process at least 10-15specimens per week to ma<strong>in</strong>ta<strong>in</strong> pr<strong>of</strong>iciency <strong>and</strong> those process<strong>in</strong>g specimens for culture should h<strong>and</strong>le am<strong>in</strong>imum <strong>of</strong> approximately 20 specimens per week. 114-117 The majority <strong>of</strong> laboratories <strong>in</strong> Irel<strong>and</strong> are Level 2.Table 4.1: Levels <strong>of</strong> service for diagnostic microbiology laboratoriesLaboratoryservice levelLevel 1Level 2Collecti<strong>on</strong> <strong>and</strong> transport <strong>of</strong> specimens; preparati<strong>on</strong> <strong>and</strong> exam<strong>in</strong>ati<strong>on</strong> <strong>of</strong> smears for AFB.Procedures <strong>of</strong> level 1, plus procedures for <strong>the</strong> isolati<strong>on</strong> <strong>of</strong> Mycobacterium species.Identificati<strong>on</strong> <strong>of</strong> M. tuberculosis complex may or may not be performed.Level 3All procedures <strong>in</strong> level 2, plus identificati<strong>on</strong> <strong>of</strong> all species <strong>of</strong> mycobacteria. The determ<strong>in</strong>ati<strong>on</strong><strong>of</strong> drug susceptibility for all Mycobacterium species <strong>and</strong> typ<strong>in</strong>g <strong>of</strong> M. tuberculosis complexshould be performed at level 3.-44-

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