Table 2.

Summary of selected test validation studies (n = 15) for Mycobacterium bovis in free-range, captive, and farmed wild mammals published between 2008 and 2017.

Reference no.	Publication year	Species	Specimen type	Index test(s)	Reference standard(s)	Source population available/population matches purpose	Comments on study design and inference*
67	2008	Badgers, white-tailed deer, brushtail possums, wild boar	Serum	MAPIA, rapid test	Culture	Yes/partial
26	2009	Wild meerkats	Serum, submandibular lymph node	MAPIA, rapid test	Culture	Yes/partial	No details about selection of animals. Repeated samples from same individual animals. Used Bayesian latent class analysis.
78	2009	White-tailed deer	Whole blood, serum	MAPIA, rapid test, immunoblot, ELISA	Culture	Yes/no	No. of positive and negative results not specified.
39	2009	Fallow deer, roe deer, red deer	Serum	Rapid test	Culture	No/no	Infection can be masked by latent or subclinical infection. Low positive predictive value could be a result of the stage of infection and cross-reactions.
45	2010	Wood bison	Serum	FPA, CFT, MAPIA, rapid test	Culture and histopathology	Yes/no	All animals were tested. Challenge of detecting infected individuals with antemortem tests was described.
76	2012	Elk, white-tailed deer, reindeer	Serum	Stat-Pak, MAPIA, DPP VetTB assay	SCT	No/unsure	Focused on DSp and estimate for DSe was from a limited number of samples. DSe determined using serologic test could be lost using skin test. Convenience sampling was used.
8	2012	Fallow deer	Serum	DPP VetTB assay (DPP5-5), bPPD ELISA	Culture	No/no	Mix of wild and farmed deer for both confirmed infected and non-infected subpopulations.
79	2013	Black bears, bobcats, coyotes, opossum, raccoon, red fox, etc.	Historical database	Gross lesions, histopathology, acid-fast bacteria	Culture	No/no	Secondary data analysis. Pooling of results from multiple species might bias estimates, thereby limiting inference.
68	2013	White-tailed deer	Serum	DPP VetTB assay	Culture	No/no	Mix of experimental infections, wild, and farmed deer.
116	2014	White-tailed deer	Serum	Ethanol vortex ELISA	Culture	No/no	Mix of experimental infections, wild, and farmed deer. OIE validation chapters or related studies cited.
99	2014	Elk	Serum	LST, FPA, Cervid TB Stat-Pak	Culture	Yes/yes	Opportunistic sampling6.4. Bias uncorrected. Used classical statistical tests and latent class analysis for test validation.
114	2016	African buffalo	Serum	SICTT, IFN-γ release assays (IRA), ELISA	Culture	Yes/unsure	Relative DSe was reported. Limited sample size but 95% CI reported. OIE validation chapter or related studies cited.
90	2016	Warthogs	Serum	Indirect PPD, ELISAs, TB ELISA-VK, DPP VetTB assay	Culture	Yes/unsure	Opportunistic sampling. Limited sample size, but 95% CI reported.
3	2017	Eurasian wild boar	Oral, nasal, fecal swabs	PCR	Culture	Yes/unsure	Limited sample size with wide CI.
107	2017	European badger	Feces	IMS-IFD, IMS-qPCR, IMS-culture	Culture	Yes/partial	Two sets of samples might represent different source populations.

CFT = caudal-fold test; CI = confidence interval; Culture = mycobacterial culture; DPP = dual-path platform; ELISA = enzyme-linked immunosorbent assay; DSe = diagnostic sensitivity; DSp = diagnostic specificity; FPA = fluorescence polarization assay; IMS-IFD = immunochromatographic lateral flow device; IMS-qPCR = immunomagnetic separation quantitative PCR; IRA = gamma-interferon release assay; LST = lymphocyte stimulation test; MAPIA = multi-antigen print immunoassay; PPD, bPPD = purified protein derivative, bovine purified protein derivative; rapid test = a lateral-flow rapid test; SICCT = single intradermal comparative cervical test; Stat-Pak = lateral flow immunoassay rapid test. For interpretation of convenience and opportunistic sampling, refer to the Results.

^*Whether OIE chapters or related studies^{34,36,40,49,121,122} were cited; this indicates whether the paper has followed principles or methodologic guidelines for test validation in wildlife mammals.