TB Case Management

1. TB Case Management Resources & Odd Bits July 7, 2009

2. Tuberculin Skin Testing A Review

3. TB Prevention and Control Policies and Procedures • Based on USPHS/CDC, ATS, IDSA and Pediatric “Red Book” guidelines

4. per 100 000 pop < 10 10 - 24 25 - 49 50 - 99 100 - 299 300 or more No estimate Estimated TB Incidence Rates, 2006

5. Mantoux Tuberculin Skin Test (TST) • A test for TB infection only • Until recently – only test available • Interpretation of TST result based on: • Size of the induration (swelling) and • Person’s risk factors for TB • Quantiferon

6. TB Skin Testing = TST • Screening • Planting (Administration) • Measurement • Interpretation • Follow-up

7. Screening

8. Purpose of TB Screening • Identify individuals with TB infection and TB disease • Provide appropriate treatment Overall goals • Reduce morbidity in community • Reduce transmission

9. Why Screen? • Assess for symptoms • Assess for risk of acquiring LTBI • Assess for risk factors for developing TB disease, if infected • Need to know risk to determine the results

10. A decision to test is a decision to treat Symptom screening and assessment of risk is a must before planting the skin test Make sure client is available to return for reading in 48 to 72 hours Remember !!!!

11. Planting

12. TST….. Who Can Administer? • IN VIRGINIA - only prescribers (MD, NP & PA) RN’s and LPN’s( working under the direct supervision of an RN ) can legally possess and administer tuberculin which is regulated as a class VI substance. • IN KENTUCKY –The Tuberculin Skin Test can be given by the following medical personnel: RN, Medical Doctor, Physicians Assistant, Nurse Practitioner, LPN (under the supervision of a Registered Nurse) 902 KAR 20:016, Kentucky Board of Nursing, PHPR

13. The Mantoux test • Different types of tuberculin tests are available • The Mantoux method is the preferred test • Purified protein derivative or “PPD”

14. How is the Mantoux skin test given? • Inject 0.1 ml of 5 tuberculin units of liquid tuberculin (PPD) between the layers of the skin (intradermally) • Usually on the forearm (dorsal or volar surface) • Inject at 5-15 degree angle • Tense white wheal – 6-10 mm

15. Instructions for patient • Information on return for reading • Don’t scratch! • Do not cover with bandage • Shower, swimming, etc. okay.

16. Storage and Handling of PPD • Date and initial when vial is opened • Discard 30 days after opening • Keep out of light • Draw up just prior to injection – read the label – PREVENT MEDICATION ERRORS! • Store at 35 to 46 degrees F° in a refrigerator or cooler with ice packs

17. Emergency Box • Anaphylaxis can occur with the administration of any drug, including a TST • Have written protocols in place • Periodically check expiration dates on drugs • Annual training of personnel

18. Tubersol vs. Aplisol • Conclusions of a 2-part 4 year long CDC study • “Both Tubersol and Aplisol have equally high specificity and sensitivity” • “False-positives not a worry, study concludes” • “Best way to avoid false-positives is not to test people unnecessarily” • Recent anecdotal discussion of issues surfacing again

19. Tubersol vs. Aplisol • Consistency is important. The CDC recommends the use of one PPD preparation consistently. Switching may affect the rate of positive TST results. • Tubersol is the recommended preparation for Kentucky • This recommendation is sited in the PHPR

22. Giving the Mantoux tuberculin skin test

25. Measurement

29. Interpretation

30. Classifying the Tuberculin Reaction • >5 mm is classified as positive in • HIV-positive persons • Recent contacts of TB case • Persons with fibrotic changes on chest radiograph • consistent with old healed TB • Patients with organ transplants and other • immunosuppressed patients

31. Classifyingthe Tuberculin Reaction • >10 mm is classified as positive in • Recent arrivals from high-prevalence countries • Injection drug users • Residents and employees of high-risk congregate settings • Mycobacteriology laboratory personnel • Persons with clinical conditions that place them at high risk • Children <4 years of age, or children and adolescents exposed to adults in high-risk categories

32. Classifying the Tuberculin Reaction • >15 mm is classified as positive in • Persons with no known risk factors for TB • Testing programs should only be conducted among high-risk groups

33. Factors That Can Cause A False-Positive Reading • Infection with non-tuberculous mycobacteria (mycobacterium, other than M.tb or MOTT) • Vaccination with BCG • BCG is not a contraindication for TST ! • Follow-up of positive reaction the same • CXR • Evaluation for treatment

34. Factors That Can Cause A False-Negative Reading • Recent TB infection • It takes 2 - 10 weeks after TB infection for the body’s immune system to be able to react to the tuberculin • Very young age (< 6 months old) • Live virus vaccination (e.g., MMR, varicella) • Defer TST 4-6 weeks • Immunosuppressive drugs (corticosteroids, new class of arthritis drugs) • Overwhelming active TB

35. Recording the PPD Test Reaction • Recording the skin test reading is a two-step process • Determine the measurement of the TST reaction in mm of induration • Determine the significance of the reaction • Based on individual’s risk factors • 11 mm, positive or 11 mm, negative or 0 mm, negative

36. Follow-up

37. Follow-up of reactors • Refer all positive TST for CXR and evaluation for treatment

38. The odds & ends of TSTs

39. Two-Step Testing • Perform on all newly employed health care workers who • Have an initial negative TB skin test result, and • Have not had a documented negative TB skin test result during the preceding 12 months • Repeat TST 1-3 weeks after first test • Timing of repeat dependent on work status

40. TST: infection control reminders • Needles should not be recapped, bent, broken, or removed from syringes • Gloves are not necessary for administering intradermal injections • Safety needles preferred

41. Important things to remember • A decision to test is a decision to treat. • TST must be read 48 hr to 72 hrs past placement. Make sure the client can come back within that time, or schedule another time for placement. • Positive test can be read up to one week per CDC • Documentation is important. If not documented not done. Includes reading. • TST may be placed the same day as a live vaccine is given. However, if live vaccine given must wait 1 month before TST.

42. New Laboratory Tests for Tuberculosis

43. QuantiFERON® FDA approved in 2005 – QFT-G InTube approved 10/07 Detects release of interferon-gamma in fresh heparinized whole blood when incubated with synthetic peptides present in M. tb. ESAT6 – early secretory antigenic target-6 CFP-10 – culture filtrate protein May be useful in contact investigations, evaluation of recent immigrants, and testing for infection control purposes Caution for use in selected populations( young children, immune compromised, suspects) Time requirements and access remain limitations

44. T-SPOT.TB Now FDA approved – July 30, 2008 Uses same peptides to determine presence of infection – (ESAT6 & CFP-10) Provides reliable results inall targeted groups, including*: Immunosuppressed BCG vaccinated TB suspects TB contacts Health Care Workers Sensitivity of 95.6% Specificity of 97.1%

45. Nucleic Acid Amplification Tests • Emerged as alternatives to conventional tests – provide more rapid results • Studied extensively to determine accuracy • Today more standardized and widely accepted • Positive results are generally reliable • Not out of woods with negative result • Still need conventional tests • Adjunct for clinical and contact investigation decisions

46. The Dictionary of Acronyms • NAA – nucleic acid amplification – amplifies IS6110 – all rapid tests based on this • PCR – polymerase chain reaction – most widely used NAA test • MTD – Mycobacterium tuberculosis direct test or detection

47. Molecular Susceptibilities • Now available at limited public health laboratories • Provide rapid testing for isoniazid and rifampin – can rule out (or in) MDRTB!

48. Funding for MTD Testing - Virginia • Test not available through DCLS • Test available through VDH LabCorp contract – current price ~ $100 • Authorization required in ADVANCE! • Prepare ATV with copy of LabCorp billing and send to DDP-tb for reimbursement • Use LabCorp form – do not use DCLS forms or send to DCLS • In-state availability may change soon – stay tuned!

49. Obtaining NAA Testing - Kentucky • The Kentucky Division of Laboratory Services performs the MTD NAA testing on first time smear positive specimens. • Specimens must meet the criteria for testing. • Sputum or bronchial specimens • Signs/symptoms consistent with active pulmonary TB • The patient should not have been on therapy for more than seven days

50. Obtaining NAA Testing - Kentucky • Policies are being developed to support the recent CDC recommendations for NAA testing. • NAA testing on smear negative patients with signs and symptoms consistent with TB is done after consultation with the TB Program.