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Table 2 Biocontainment and mitigation regulations for Orientia spp.

From: Biosafety and biosecurity requirements for Orientia spp. diagnosis and research: recommendations for risk-based biocontainment, work practices and the case for reclassification to risk group 2

   Laboratory studies
CountryRegulationsActivityLow-riskEnhanced-risk
USABMBL5th Ed. [21]Clinical“BSL2 practices, biocontainment equipment, and facilities are recommended for non-propagative laboratory procedures, including serological and fluorescent antibody procedures, and for the staining of impression smears.New species are being described frequently and should be evaluated for appropriate biocontainment on a case-by-case basis. Because of the proven value of antibiotic therapy in the early stages of rickettsial infection, it is essential that laboratories have an effective system for reporting febrile illnesses in laboratory personnel, medical evaluation of potential cases and, when indicated, institution of appropriate antibiotic therapy.
  ResearchR prowazekii; R typhi (R. mooseri); Orientia (Rickettsia) tsutsugamushi and Spotted Fever Group agents of human disease; R rickettsii, R conorii, R akari, R australis, R siberica, and R japonicum - BSL3 practices, biocontainment equipment, and facilities are recommended for all other manipulations of known or potentially infectious materials, including necropsy of experimentally infected animals and trituration of their tissues, and inoculation, incubation, and harvesting of embryonated eggs or cell cultures.
R. montana, R. rhipicephali, R. belli, and R. canada,- are not known to cause human disease and may be handled under BSL2 conditions.
 
UKACDP [20]Clinical“Microbiology laboratories offering a diagnostic service to a hospital will from time to time isolate a hazard group 3 pathogen when working at CL2. Once identified, work on such isolates and on material known or suspected to contain hazard group 3 biological agents must be conducted in a CL 3 laboratory, unless the agent is specifically identified as an exemption in the ACDP Second supplement 2000.”“It is recognised that pathogens may be present in specimens which, had they been identified, would need to be handled at a higher level of containment. If such pathogens are identified during the course of work at CL 2, all further work on the specimen or associated specimens must be conducted at a higher biocontainment level, usually CL 3 or exceptionally CL 4. If higher biocontainment level facilities are not available, the isolate should be sent to an appropriate laboratory, or be destroyed. If it is suspected, for example from a clinical history, that a specimen may contain hazard group 3 biological agents, all work on that specimen or other specimens from that patient must be conducted at CL3.”
  Research Rickettsia spp (specified as the following R. akari, R canada, R conorii, R montana, R prowazekii, R rickettsii, R (Orientia) tsutsugamushi, R sennetsu, R typhi) are classified as a Hazard Group 3 Pathogen “the minimum biocontainment level… shall be…— level 3 for activities which involve working with a Group 3 biological agent” and so in the UK all work with known Orientia spp. must be conducted in a CL3/BSL 3 laboratory.
AustraliaAS/NZS 2243.3.2010 [16]ClinicalClinical specimens are generally regarded as low risk and handled under BSL2 conditions. Very few laboratories attempt cell culture isolation of Orientia spp. from clinical specimens and the recovery rate of viable organisms is very low. However, once an isolate has been identified the specimen must be subsequently be handled at BSL3.There may be a need for further characterisation of a clinical isolate with respect to typing and as such these activities need to be performed at BSL3.
  ResearchInactivated Orientia isolates can be handled at BSL2All viable Orientia/rickettsial agents need to be handled at BSL3.
SingaporeBATA 2005 [22]ClinicalFor samples where the diagnosis is unknown, diagnostic testing that does not result in amplification of the pathogen tested for can be performed in a BSL2 environment.
Laboratories conducting clinical diagnostics of Rickettsia and Orientia spp. are required to conduct risk assessment and provide appropriate measures and safeguards to significantly reduce risk of infection of laboratory staff.
In enhanced risk situation, the work environment will need to be BSL3. This covers all work that involves “live” organisms in the sample or culture, whereby no prior approved steps have been applied to the material that would render the pathogen inert and non-infectious.
  ResearchFor research work on live samples and cultures, the work environment is required to be at BSL3.
Large scale culture (> 10 l) is prohibited without written authorization of the Director of Medical Services, Ministry of Health Singapore.
ThailandPathogens and Animals Toxins Act 2015 [23]ClinicalRoutine diagnostic laboratory processing within hospital laboratories can be performed in BSL-2 laboratories with strict adherence to Good Laboratory Practice guidelines.Culturing with the aim of producing large amounts of bacteria should be performed in BSL3 laboratories or equivalent safety level (BSL2 enhanced).
  ResearchAs per clinical activity
  1. BSL biological safety level, ACDP advisory committee on dangerous pathogens, CL biocontainmentlevel, AS/NZS Australian/New Zealand Standards, BATA biologicals and toxins act