Conservation of purified protein derivative RT-23 tuberculin
A Fernández-Villar1, A Gorís, M Otero
1Unidad de Tuberculosis de Vigo, Servicio de Neumología, Complejo Hospitalario Universitario Xeral-Cíes, Vigo, Joaquin Costa 60.6, 36004 Pontevedra, España. jfv01po@sakudalia.com
Objective:
Recommendations that purified protein derivative (PPD) RT-23 tuberculin should not be kept and used more than 24 to 48 hours after opening are rarely complied with. The aim of this study was to determine whether using PPD RT-23 tuberculin from vials that had been open for a longer time could affect results of tuberculin tests and whether the solution could become contaminated.
Methods:
A prospective cross-sectional study was carried out. Two tuberculin tests were simultaneously administered, one in each forearm, to adult contacts of patients with active tuberculosis, one test using a recently opened vial of tuberculin (control) and the other using tuberculin that had been opened a week before (first phase) or a month before (second phase) (study tuberculin). Leftover tuberculin from several of the vials was cultured.
Results:
For the 127 patients in the first group (tuberculin opened 1 week), the mean (SD) diameter of the induration was 6.2 (6.9) mm for the study tuberculin and 6.3 (6.9) mm for the control (P=.3). For the 83 patients in the second group (tuberculin opened 1 month), the mean diameter of the induration was 5.5 (7.3) mm for the study tuberculin and 5.7 (7.3) mm for the control (P=.5). There were no differences between the number of positive tests found. None of the cultured tuberculins produced bacterial growth.
Conclusions:
PPD RT-23 tuberculin does not appear to lose potency or sterility when vials have been opened for a week or a month.
Insights
Purified protein derivative (PPD) RT-23 tuberculin remains potent and sterile for at least one month after opening, challenging current storage recommendations. This study found no significant difference in tuberculin test results or contamination when using older vials.
Area of Science:
- Microbiology
- Immunology
- Public Health
Background:
- Current guidelines recommend discarding purified protein derivative (PPD) RT-23 tuberculin within 24-48 hours of opening.
- These recommendations are often not followed in clinical practice.
- The stability and sterility of PPD RT-23 tuberculin after prolonged opening periods are not well-established.
Purpose of the Study:
- To evaluate the impact of using PPD RT-23 tuberculin from vials opened for extended periods (1 week and 1 month) on tuberculin test results.
- To assess the potential for bacterial contamination in PPD RT-23 tuberculin vials after prolonged opening.
Main Methods:
- A prospective cross-sectional study involving adult contacts of active tuberculosis patients.
- Simultaneous administration of two tuberculin tests: one with a recently opened vial (control) and one with a vial opened 1 week or 1 month prior (study).
- Bacterial cultures were performed on leftover tuberculin from several vials.
Main Results:
- No statistically significant difference in the mean induration diameter was observed between the study and control tuberculin tests at 1 week (6.2 mm vs. 6.3 mm, P=.3) or 1 month (5.5 mm vs. 5.7 mm, P=.5).
- The number of positive tuberculin tests was comparable between the groups.
- None of the cultured tuberculin samples showed bacterial growth.
Conclusions:
- PPD RT-23 tuberculin maintains its potency and sterility even when vials are opened for up to one month.
- The findings suggest that current recommendations for PPD RT-23 tuberculin vial usage duration may be overly conservative.
- This study supports the extended usability of PPD RT-23 tuberculin, potentially improving resource utilization in tuberculosis screening programs.
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