KVG team wishes to share the following with the viewers and supporters of "End TB Programme" as tuberculin skin test [Mantoux test] is in practice since 1907 however there are many programmatic errors happening at the service delivery point which can be witnessed by anybody anywhere in the country administering tuberculin.
Context: The Union Government has rolled out a programme for universal screening of an estimated 250 million children and adolescents below 18 years annually for Leprosy and Tuberculosis (TB) and put on treatment if required. TB kills an estimated 4.8 lakh Indians (sharing 31% of global TB deaths) every year [>1,400 every day]. India has the highest TB burden (27% of the world) with more than a million ‘missing’ cases every year that are not notified – either undiagnosed, unaccountable, inadequately diagnosed and treated in the private sector. (https://indianexpress.com/article/india/govt-rolls-out-scheme-to-screen-all-children-below-18-for-leprosy-tb-5943004/ accessed on 06-09-2019).
In this regard Manotux test [TST] has a definite role. Tuberculin Skin Test (TST) is a simple and reasonably reliable method for the detection of infection by Mycobacterium tuberculosis. It is a diagnostic aid for corroborating with clinical findings though not a confirmatory test.
Quote: It has to be approached “with respect, administered with care, read with deliberation and interpreted with sentient discrimination.”
Programmatic errors observed during opportunistic proactive supportive supervision:
All the 8 rights to be observed before / while and after administering vaccines are applicable to Tuberculin also plus 2 more: a) Do’s and Don’ts for the patient during the reactogenic period of 0 to 48hrs; b) reading the test between 48 and 72 hours without fail.
In almost all Medical Colleges visited in 4 states, tuberculin manufactured by “arkray” with different strengths is used: viz. 1TU, 2TU, 5TU and 10TU RT23 in 0.1mL, 5mL per vial providing 50 ID doses of 0.1mL each. Though the test is in practice since 1907, following programmatic errors in various permutation combinations were observed in different thematic areas of administering / reading TST:
- Cold chain: Stored in domestic refrigerator with vertical door opening horizontally. Often kept in the inner aspect of door abutting freezer compartment, tuberculin getting frequently frozen. Once brought from the main store, kept in the tray at the service point during working hours, often till the last dose in some institutions for couple of months.
- VVM: In India, tuberculin is not dressed with VVM and hence the potency of the reagent at any time is not known.
- Pediatric age: No uniformity, ranging from 0 – 5yrs to 0 – 18yrs.
- About TU per 0.1mL and the units administered: “Testers” are not aware of number of TU per 0.1mL as a result in one college 10TU per 0.1mL is administered to children and 1TU in 0.1mL to adults. Different colleges are administering different strengths: 2 TU in 0.1mL for all, 5 TU in 0.1mL for all and 10 TU in 0.1mL for all.
- Quantity / volume: 0.05mL of 2TU in 0.1mL to children, 0.05mL of 5 TU in 0.1mL for children, 0.025mL (one digit from insulin syringe) of 10 TU in 0.1mL for children & or quantity made up to 0.1mL diluting with normal saline were administered. Volume < 0.1mL cannot yield wheal of required diameter of ≥7mm diameter; smaller diameter is like providing "badminton court for playing foot ball".
- Route: Often administered Sub Cutaneously.
- Multi dose vial policy: Once the vial is opened (opening date), same vial is used beyond the recommended 30 days till the last dose, with or without cold chain. Opening date and Beyond Useable Date (BUD) are not mentioned on the vial, not in compliance with guidelines.
- Trained staff: Testers are not “dedicatedly” trained for administering tuberculin, but many regular staff nurses & or lab technicians could administer intradermally correctly. In some institutions “testers” are not “dedicated”, anybody is allowed to administer from nursing students, interns, Post graduates.
- Wheal: The diameter of the wheal is not measured hence if the wheal is small (≤6mm); there is no repetition of the test immediately.
- AEFI Kit: Not available at many places.
- No display of standard operating procedure and job-aid at the service point.
- 2 step tests in needy circumstances are not in practice.
- Documentation: No standard documentation hence no indicators can be obtained required for performance review / operational research if any.
- Instructions to the patient / beneficiary: Explaining the procedure and giving Key messages to the patient are hardly adhered.
- Reading of the test: Test needs to be read between 48 and 72 hrs unlike many test doses in medical practice which is read ~30 minutes of administering the test dose. In substantial cases results were not read (~30%) defeating the purpose of the test.
What we did:
- Charity should begin at home. We established nursing station for administering tuberculin skin test in the dedicated vaccination clinic in KVG Medical College by the dedicated staff.
- Developed a Supportive Supervision checklist as per CDC and RNTCP guidelines, used the same in the capacity building of testers and the officers in various Medical Colleges.
- Regularly shared the observations with DTF, STF, ZTF and NTF.
- We appraised the visitors to our college.
- As directed by the State Task Force, in collaboration with DTO, conducted training workshops to the Matron, testers of Medical Colleges of home district at the “Demo-site” of KVG Medical College.
- As directed by STF, experiences of training workshop presented in the STF meeting at State Institute of Health and Family Welfare on 7th June 2019.
Way forward: Conducting similar CMEW in all the Medical Colleges of Karnataka for sensitization followed by intensive training of testers in small batches at the “Demo-site” in KVG Medical College in collaboration with government.
Acknowledgement: We thank all the supporters of “End TB” programme.