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Commission Implementing Decision of 8 August 2012 amending Decision 2002/253/EC laying down case definitions for reporting communicable diseases to the Community network under Decision No 2119/98/EC of the European Parliament and of the Council (notified under document C(2012) 5538) (Text with EEA relevance) (2012/506/EU)

EU Decision 2012/506 · Adopted 8 August 2012 · Extends to United Kingdom

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Commission Implementing Decision

of 8 August 2012

amending Decision 2002/253/EC laying down case definitions for reporting communicable diseases to the Community network under Decision No 2119/98/EC of the European Parliament and of the Council

(notified under document C(2012) 5538)

(Text with EEA relevance)

(2012/506/EU)

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Decision No 2119/98/EC of the European Parliament and of the Council of 24 September 1998 setting up a network for the epidemiological surveillance and control of communicable diseases in the Communityf1, and in particular Article 3(c) thereof,

Whereas:

(1)

According to Article 2 of Commission Decision 2002/253/ECf2, the case definitions laid down in the Annex to that Decision should be updated to the extent necessary on the basis of the latest scientific data.

(2)

In accordance with Article 9 of Regulation (EC) No 851/2004 of the European Parliament and of the Council of 21 April 2004 establishing a European Centre for disease prevention and controlf3 (ECDC), the ECDC provided, at the request of the Commission, a scientific opinion on case definitions aiding the Commission and the Member States in the development of intervention strategies in the field of surveillance of and response to communicable diseases.

(3)

The case definitions already listed in the Annex to Decision 2002/253/EC for HIV/AIDS, diphtheria, Haemophilus influenzae (invasive disease), hepatitis B and C, meningococcal disease, mumps, legionellosis, congenital rubella, shiga toxin/verocytotoxin producing Escherichia coli infection (STEC/VTEC), salmonellosis and leptospirosis should be updated on the basis of that scientific opinion provided by ECDC.

(4)

A generic case definition of antimicrobial resistance, a generic definition of nosocomial infections, a number of specific case definitions of nosocomial infections, and a case definition for tick-borne encephalitis should also be added to the Annex to Decision 2002/253/EC on the basis of that scientific opinion provided by ECDC.

(5)

For the purpose of clarity, it is appropriate to restructure the Annex to Decision 2002/253/EC in order to ensure that case definitions for communicable diseases are in a separate list from those for special health issues, and that, within each list, the case definitions appear in numerical order.

(6)

The measures provided for in this Decision are in accordance with the opinion of the Committee set up by Decision No 2119/98/EC,

HAS ADOPTED THIS DECISION:

Annotations to the whole text

Footnotes

f1

OJ L 268, 3.10.1998, p. 1.

f2

OJ L 86, 3.4.2002, p. 44.

f3

OJ L 142, 30.4.2004, p. 1.

Contents

  1. 1Article 1
  2. 2Article 2
  3. Signature
  4. Annex
  5. EXPLANATION OF THE SECTIONS USED IN THE DEFINITION AND CLASSIFICATION OF CASES
  6. Clinical criteria
  7. Laboratory criteria
  8. Epidemiological criteria and epidemiological link
  9. Case classification
  10. Possible case
  11. Probable case
  12. Confirmed case
  13. Laboratory-confirmed case with clinical criteria
  14. Laboratory-confirmed case with unknown clinical criteria
  15. Laboratory-confirmed case without clinical criteria
  16. CASE DEFINITIONS OF COMMUNICABLE DISEASES
  17. ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS) AND HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION
  18. Clinical Criteria (AIDS)
  19. Laboratory Criteria (HIV)
  20. Epidemiological Criteria NA
  21. Case Classification
  22. Possible case NA
  23. Probable case NA
  24. CConfirmed case
  25. ANTHRAX (Bacillus anthracis)
  26. Clinical Criteria
  27. Cutaneous anthrax
  28. Gastrointestinal anthrax
  29. Inhalational anthrax
  30. Meningeal/meningoencephalitic anthrax
  31. Anthrax septicaemia
  32. Laboratory Criteria
  33. Epidemiological Criteria
  34. Case Classification
  35. Possible case NA
  36. BProbable case
  37. CConfirmed case
  38. AVIAN INFLUENZA A/H5 OR A/H5N1 IN HUMANS
  39. Clinical Criteria
  40. Laboratory Criteria
  41. Epidemiological Criteria
  42. Case Classification
  43. APossible case
  44. BProbable case
  45. CNationally confirmed case
  46. DWHO confirmed case
  47. BOTULISM (Clostridium botulinum)
  48. Clinical Criteria
  49. Food-borne and wound botulism
  50. Infant botulism
  51. Laboratory Criteria
  52. Epidemiological Criteria
  53. Case Classification
  54. Possible case NA
  55. BProbable case
  56. CConfirmed case
  57. BRUCELLOSIS (Brucella spp.)
  58. Clinical Criteria
  59. Laboratory Criteria
  60. Epidemiological Criteria
  61. Case Classification
  62. Possible case NA
  63. BProbable case
  64. CConfirmed case
  65. CAMPYLOBACTERIOSIS (Campylobacter spp.)
  66. Clinical Criteria
  67. Laboratory Criteria
  68. Epidemiological Criteria
  69. Case Classification
  70. Possible case NA
  71. BProbable case
  72. CConfirmed case
  73. CHLAMYDIAL INFECTION (Chlamydia trachomatis), INCLUDING LYMPHOGRANULOMA VENEREUM (LGV)
  74. Clinical Criteria
  75. Chlamydial infection non-LGV
  76. LGV
  77. Laboratory Criteria
  78. Chlamydial infection non-LGV
  79. LGV
  80. Epidemiological Criteria
  81. Case Classification
  82. Possible case NA
  83. BProbable case
  84. CConfirmed case
  85. CHOLERA (Vibrio cholerae)
  86. Clinical Criteria
  87. Laboratory Criteria
  88. Epidemiological Criteria
  89. Case Classification
  90. Possible case NA
  91. BProbable case
  92. CConfirmed case
  93. CREUTZFELDT-JAKOB DISEASE, VARIANT (vCJD)
  94. Preconditions
  95. Clinical Criteria
  96. Diagnostic Criteria
  97. Diagnostic criteria for case confirmation:
  98. Diagnostic criteria for a probable or a possible case:
  99. Epidemiological Criteria
  100. Case Classification
  101. APossible case
  102. BProbable case
  103. CConfirmed case
  104. CRYPTOSPORIDIOSIS (Cryptosporidium spp.)
  105. Clinical Criteria
  106. Laboratory Criteria
  107. Epidemiological Criteria
  108. Case Classification
  109. Possible case NA
  110. BProbable case
  111. CConfirmed case
  112. DIPHTHERIA (Corynebacterium diphtheriae, Corynebacterium ulcerans and Corynebacterium pseudotuberculosis)
  113. Clinical Criteria
  114. Classic Respiratory Diphtheria:
  115. Mild Respiratory Diphtheria:
  116. Cutaneous Diphtheria:
  117. Diphtheria of other sites:
  118. Laboratory Criteria
  119. Epidemiological Criteria
  120. Case Classification
  121. APossible case
  122. BProbable case
  123. CConfirmed case
  124. ECHINOCOCCOSIS (Echinococcus spp.)
  125. Clinical Criteria
  126. Diagnostic Criteria
  127. Epidemiological Criteria NA
  128. Case Classification
  129. Possible case NA
  130. Probable case NA
  131. CConfirmed case
  132. GIARDIASIS (Giardia lamblia)
  133. Clinical Criteria
  134. Laboratory Criteria
  135. Epidemiological Criteria
  136. Case Classification
  137. Possible case NA
  138. BProbable case
  139. CConfirmed case
  140. GONORRHOEA (Neisseria gonorrhoeae)
  141. Clinical Criteria
  142. Laboratory Criteria
  143. Epidemiological Criteria
  144. Case Classification
  145. Possible case NA
  146. BProbable case
  147. CConfirmed case
  148. HAEMOPHILUS INFLUENZAE, INVASIVE DISEASE (Haemophilus influenzae)
  149. Clinical Criteria
  150. Laboratory Criteria
  151. Epidemiological Criteria NA
  152. Case Classification
  153. Possible case NA
  154. Probable case NA
  155. CConfirmed case
  156. HEPATITIS A (Hepatitis A virus)
  157. Clinical Criteria
  158. Laboratory Criteria
  159. Epidemiological Criteria
  160. Case Classification
  161. Possible case NA
  162. BProbable case
  163. CConfirmed case
  164. HEPATITIS B (Hepatitis B virus)
  165. Clinical Criteria
  166. Laboratory Criteria
  167. Epidemiological Criteria
  168. Case Classification
  169. Possible case NA
  170. Probable case NA
  171. CConfirmed case
  172. HEPATITIS C (Hepatitis C virus)
  173. Clinical Criteria
  174. Laboratory Criteria
  175. Epidemiological Criteria NA
  176. Case Classification
  177. Possible case NA
  178. Probable case NA
  179. CConfirmed case
  180. INFLUENZA (Influenza virus)
  181. Clinical Criteria
  182. Influenza-like illness (ILI)
  183. Acute respiratory infection (ARI)
  184. Laboratory Criteria
  185. Epidemiological Criteria
  186. Case Classification
  187. APossible case
  188. BProbable case
  189. CConfirmed case
  190. INFLUENZA A(H1N1)
  191. Clinical criteria
  192. Laboratory criteria
  193. Epidemiological criteria
  194. Case classification
  195. ACase under investigation
  196. BProbable case
  197. CConfirmed case
  198. LEGIONNAIRES’ DISEASE (Legionella spp.)
  199. Clinical Criteria
  200. Laboratory Criteria
  201. Epidemiological Criteria NA
  202. Case Classification
  203. Possible case NA
  204. BProbable case
  205. CConfirmed case
  206. LEPTOSPIROSIS (Leptospira spp.)
  207. Clinical Criteria
  208. Laboratory Criteria
  209. Epidemiological Criteria
  210. Case Classification
  211. Possible case NA
  212. BProbable case
  213. CConfirmed case
  214. LISTERIOSIS (Listeria monocytogenes)
  215. Clinical Criteria
  216. Laboratory Criteria
  217. Epidemiological Criteria
  218. Additional information
  219. Case Classification
  220. Possible case NA
  221. BProbable case
  222. CConfirmed case
  223. MALARIA (Plasmodium spp.)
  224. Clinical Criteria
  225. Laboratory Criteria
  226. Epidemiological Criteria NA
  227. Case Classification
  228. Possible case NA
  229. Probable case NA
  230. CConfirmed case
  231. MEASLES (Measles virus)
  232. Clinical Criteria
  233. Laboratory Criteria
  234. Epidemiological criteria
  235. Case Classification
  236. APossible case
  237. BProbable case
  238. CConfirmed case
  239. MENINGOCCOCAL DISEASE, INVASIVE (Neisseria meningitidis)
  240. Clinical Criteria
  241. Laboratory Criteria
  242. Epidemiological Criteria
  243. Case Classification
  244. APossible case
  245. BProbable case
  246. CConfirmed case
  247. MUMPS (Mumps virus)
  248. Clinical Criteria
  249. Laboratory Criteria
  250. Epidemiological Criteria
  251. Case Classification
  252. APossible case
  253. BProbable case
  254. CConfirmed case
  255. PERTUSSIS (Bordetella pertussis)
  256. Clinical Criteria
  257. Laboratory Criteria
  258. Epidemiological Criteria
  259. Case Classification
  260. APossible case
  261. BProbable case
  262. CConfirmed case
  263. PLAGUE (Yersinia pestis)
  264. Clinical Criteria
  265. Bubonic plague:
  266. Septicaemic plague:
  267. Pneumonic plague:
  268. Laboratory Criteria
  269. Epidemiological Criteria
  270. Case Classification
  271. Possible case NA
  272. BProbable case
  273. CConfirmed case
  274. PNEUMOCOCCAL INVASIVE DISEASE(S) (Streptococcus pneumoniae)
  275. Clinical Criteria
  276. Laboratory Criteria
  277. Epidemiological Criteria NA
  278. Case Classification
  279. Possible case NA
  280. Probable case NA
  281. CConfirmed case
  282. POLIOMYELITIS (Polio virus)
  283. Clinical Criteria
  284. Laboratory Criteria
  285. Epidemiological Criteria
  286. Case Classification
  287. APossible case
  288. BProbable case
  289. CConfirmed case
  290. Q FEVER (Coxiella burnetii)
  291. Clinical Criteria
  292. Laboratory Criteria
  293. Epidemiological Criteria
  294. Case Classification
  295. Possible case NA
  296. BProbable case
  297. CConfirmed case
  298. RABIES (Lyssa virus)
  299. Clinical Criteria
  300. Laboratory Criteria
  301. Epidemiological Criteria
  302. Case Classification
  303. APossible case
  304. BProbable case
  305. CConfirmed case
  306. RUBELLA (Rubella virus)
  307. Clinical Criteria
  308. Laboratory Criteria
  309. Epidemiological Criteria
  310. Case Classification
  311. APossible case
  312. BProbable case
  313. CConfirmed case
  314. RUBELLA, CONGENITAL (Including Congenital Rubella Syndrome)
  315. Clinical Criteria
  316. Congenital rubella infection (CRI)
  317. Congenital rubella syndrome (CRS)
  318. (A)
  319. (B)
  320. Laboratory Criteria
  321. Epidemiological Criteria
  322. Case Classification Congenital Rubella
  323. Possible case NA
  324. BProbable case
  325. CConfirmed case
  326. SALMONELLOSIS (Salmonella spp. other than Salmonella typhi and Salmonella paratyphi)
  327. Clinical Criteria
  328. Laboratory Criteria
  329. Epidemiological Criteria
  330. Case Classification
  331. Possible case NA
  332. BProbable case
  333. CConfirmed case
  334. SEVERE ACUTE RESPIRATORY SYNDROME — SARS (SARS-coronavirus, SARS-CoV)
  335. Clinical Criteria
  336. Laboratory Criteria
  337. Epidemiological Criteria
  338. Case Classification for the inter-epidemic period
  339. APossible case
  340. BProbable case
  341. CNationally confirmed case
  342. DConfirmed case
  343. Case Classification during an outbreak
  344. APossible case
  345. BProbable case
  346. CNationally confirmed case
  347. DConfirmed case
  348. SHIGA TOXIN/VEROCYTO-TOXIN PRODUCING ESCHERICHIA COLI INFECTION (STEC/VTEC)
  349. Clinical Criteria
  350. STEC/VTEC diarrhoea
  351. HUS
  352. Laboratory Criteria
  353. Epidemiological Criteria
  354. Case Classification
  355. APossible case of STEC-associated HUS
  356. BProbable case of STEC/VTEC
  357. CConfirmed case of STEC/VTEC
  358. SHIGELLOSIS (Shigella spp.)
  359. Clinical Criteria
  360. Laboratory Criteria
  361. Epidemiological Criteria
  362. Case Classification
  363. Possible case NA
  364. BProbable case
  365. CConfirmed case
  366. SMALLPOX (Variola virus)
  367. Clinical Criteria
  368. Laboratory Criteria
  369. Epidemiological Criteria
  370. Case Classification
  371. APossible case
  372. BProbable case
  373. CConfirmed case
  374. SYPHILIS (Treponema pallidum)
  375. Clinical Criteria
  376. Laboratory Criteria
  377. Epidemiological Criteria
  378. Case Classification
  379. Possible case NA
  380. BProbable case
  381. CConfirmed case
  382. SYPHILIS, CONGENITAL AND NEONATAL (Treponema pallidum)
  383. Clinical Criteria
  384. Laboratory Criteria
  385. Epidemiological Criteria
  386. Case Classification
  387. Possible case NA
  388. BProbable case
  389. CConfirmed case
  390. TETANUS (Clostridium tetani)
  391. Clinical Criteria
  392. Laboratory Criteria
  393. Epidemiological Criteria NA
  394. Case Classification
  395. Possible case NA
  396. BProbable case
  397. CConfirmed case
  398. TICK-BORNE ENCEPHALITIS (TBE virus)
  399. Clinical Criteria
  400. Laboratory Criteria
  401. Epidemiological Criteria
  402. Case Classification
  403. Possible case NA
  404. BProbable case
  405. CConfirmed case
  406. TOXOPLASMOSIS, CONGENITAL (Toxoplasma gondii)
  407. Clinical Criteria
  408. Laboratory Criteria
  409. Epidemiological Criteria NA
  410. Case Classification
  411. Possible case NA
  412. Probable case NA
  413. CConfirmed case
  414. TRICHINELLOSIS (Trichinella spp.)
  415. Clinical Criteria
  416. Laboratory Criteria
  417. Epidemiological Criteria
  418. Case Classification
  419. Possible case NA
  420. BProbable case
  421. CConfirmed case
  422. TUBERCULOSIS (Mycobacterium tuberculosis complex)
  423. Clinical Criteria
  424. Laboratory Criteria
  425. Epidemiological Criteria NA
  426. Case Classification
  427. APossible case
  428. BProbable case
  429. CConfirmed case
  430. TULARAEMIA (Francisella tularensis)
  431. Clinical Criteria
  432. Laboratory Criteria
  433. Epidemiological Criteria
  434. Case Classification
  435. Possible case NA
  436. BProbable case
  437. CConfirmed case
  438. TYPHOID/PARATYPHOID FEVER (Salmonella typhi/paratyphi)
  439. Clinical Criteria
  440. Laboratory Criteria
  441. Epidemiological Criteria
  442. Case Classification
  443. Possible case NA
  444. BProbable case
  445. CConfirmed case
  446. VIRAL HAEMORRHAGIC FEVERS (VHF)
  447. Clinical Criteria
  448. Laboratory Criteria
  449. Epidemiological Criteria
  450. Case Classification
  451. Possible case NA
  452. BProbable case
  453. CConfirmed case
  454. WEST NILE FEVER (West Nile virus infection, WNV)
  455. Clinical Criteria
  456. Laboratory Criteria
  457. Epidemiological Criteria
  458. Case Classification
  459. Possible case NA
  460. BProbable case
  461. CConfirmed case
  462. YELLOW FEVER (Yellow fever virus)
  463. Clinical Criteria
  464. Laboratory Criteria
  465. Epidemiological Criteria
  466. Case Classification
  467. Possible case NA
  468. BProbable case
  469. CConfirmed case
  470. YERSINIOSIS (Yersinia enterocolitica, Yersinia pseudotuberculosis)
  471. Clinical Criteria
  472. Laboratory Criteria
  473. Epidemiological Criteria
  474. Case Classification
  475. Possible case NA
  476. BProbable case
  477. CConfirmed case
  478. CASE DEFINITIONS OF SPECIAL HEALTH ISSUES
  479. 3.1GENERAL CASE DEFINITION OF NOSOCOMIAL INFECTION (OR ‘HEALTHCARE-ASSOCIATED INFECTION’)
  480. BJ: BONE AND JOINT INFECTION
  481. BJ-BONE: Osteomyelitis
  482. Note reporting instruction:
  483. BJ-JNT: Joint or bursa
  484. BJ-DISC: Disc space infection
  485. BSI: BLOODSTREAM INFECTION
  486. BSI: Laboratory-confirmed bloodstream infection
  487. CNS: CENTRAL NERVOUS SYSTEM INFECTION
  488. CNS-IC: Intracranial infection (brain abscess, subdural or epidural infection, encephalitis)
  489. Note reporting instruction:
  490. CNS-MEN: Meningitis or ventriculitis
  491. Note reporting instructions:
  492. CNS-SA: Spinal abscess without meningitis
  493. Note reporting instruction:
  494. CRI: CATHETER-RELATED INFECTION
  495. CRI1-CVC: Local CVC-related infection (no positive blood culture)
  496. CRI1-PVC: Local PVC-related infection (no positive blood culture)
  497. CRI2-CVC: General CVC-related infection (no positive blood culture)
  498. CRI2-PVC: General PVC-related infection (no positive blood culture)
  499. CRI3-CVC: microbiologically confirmed CVC-related bloodstream infection
  500. CRI3-PVC: microbiologically confirmed PVC-related bloodstream infection
  501. CVS: CARDIOVASCULAR SYSTEM INFECTION
  502. CVS-VASC: Arterial or venous infection
  503. Note reporting instructions:
  504. CVS-ENDO: Endocarditis
  505. CVS-CARD: Myocarditis or pericarditis
  506. CVS-MED: Mediastinitis
  507. Note reporting instruction:
  508. EENT: EYE, EAR, NOSE, THROAT, OR MOUTH INFECTION
  509. EENT-CONJ: Conjunctivitis
  510. Note reporting instructions:
  511. EENT-EYE: Eye, other than conjunctivitis
  512. EENT-EAR: Ear mastoid
  513. EENT-ORAL: Oral cavity (mouth, tongue, or gums)
  514. Note reporting instruction:
  515. EENT-SINU: Sinusitis
  516. EENT-UR: Upper respiratory tract, pharyngitis, laryngitis, epiglottitis
  517. GI: GASTROINTESTINAL SYSTEM INFECTION
  518. GI-CDI: Clostridium difficile infection
  519. GI-GE: Gastroenteritis (excl. CDI)
  520. GI-GIT: Gastrointestinal tract (oesophagus, stomach, small and large bowel, and rectum) excluding gastroenteritis and appendicitis
  521. GI-HEP: Hepatitis
  522. Note reporting instructions:
  523. GI-IAB: Intraabdominal, not specified elsewhere including gallbladder, bile ducts, liver (excluding viral hepatitis), spleen, pancreas, peritoneum, subphrenic or subdiaphragmatic space, or other intraabdominal tissue or area not specified elsewhere
  524. Note reporting instruction:
  525. LRI: LOWER RESPIRATORY TRACT INFECTION, OTHER THAN PNEUMONIA
  526. LRI-BRON: Bronchitis, tracheobronchitis, bronchiolitis, tracheitis, without evidence of pneumonia
  527. Note reporting instruction:
  528. LRI-LUNG: Other infections of the lower respiratory tract
  529. Note reporting instruction:
  530. NEO: SPECIFIC NEONATAL CASE DEFINITIONS
  531. NEO-CSEP: Clinical Sepsis
  532. NEO-LCBI: Laboratory-confirmed BSI
  533. Note reporting instructions:
  534. NEO-CNSB: Laboratory-confirmed BSI with coagulase-negative staphylococci (CNS)
  535. Note reporting instructions:
  536. NEO-PNEU: Pneumonia
  537. NEO-NEC: Necrotising enterocolitis
  538. 3.1.10PN: PNEUMONIA
  539. (a)Bacteriologic diagnostic performed by:
  540. (b)Alternative microbiology methods (PN 3)
  541. (c)Others
  542. Note:Division Note:
  543. Intubation-associated pneumonia (IAP)
  544. Note:Division Note:
  545. REPR: REPRODUCTIVE TRACT INFECTION
  546. REPR-EMET: Endometritis
  547. Note reporting instruction:
  548. REPR-EPIS: Episiotomy
  549. REPR-VCUF: Vaginal cuff
  550. Note reporting instruction:
  551. REPR-OREP: Other infections of the male or female reproductive tract (epididymis, testes, prostate, vagina, ovaries, uterus, or other deep pelvic tissues, excluding endometritis or vaginal cuff infections)
  552. Note reporting instructions:
  553. SSI: SURGICAL SITE INFECTION
  554. Note:Division Note:
  555. Superficial incisional (SSI-S)
  556. Deep incisional (SSI-D)
  557. Organ/Space (SSI-O)
  558. SST: SKIN AND SOFT TISSUE INFECTION
  559. SST-SKIN: Skin infection
  560. Note reporting instructions:
  561. SST-ST: Soft tissue (necrotising fascitis, infectious gangrene, necrotising cellulitis, infectious myositis, lymphadenitis, or lymphangitis)
  562. Note reporting instructions:
  563. SST-DECU: Decubitus ulcer, including both superficial and deep infections
  564. SST-BURN: Burn
  565. SST-BRST: Breast abscess or mastitis
  566. SYS: SYSTEMIC INFECTION
  567. SYS-DI: Disseminated infection
  568. Note reporting instructions:
  569. SYS-CSEP: Clinical sepsis in adults and children
  570. Note reporting instructions:
  571. UTI: URINARY TRACT INFECTION
  572. UTI-A: microbiologically confirmed symptomatic UTI
  573. UTI-B: not microbiologically confirmed symptomatic UTI
  574. GENERIC CASE DEFINITION OF ANTIMICROBIAL RESISTANCE
  575. Definition
  576. Clinically Susceptible (S)
  577. Clinically Intermediate (I)
  578. Clinically Resistant (R)
  579. Clinical breakpoints are presented as S≤x mg/L; I>x, ≤y mg/L; R>y mg/L