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Updated: Jun 5, 2026

An Automated Culture System for Use in Preclinical Testing of Host-Directed Therapies for Tuberculosis
Published on: August 16, 2021
Comparative study of RT23 and IC-65 tuberculins tested on children with tuberculosis
Irina Ulea1, Gheorghe Murgoci, Mircea Loan Popa
1National Institute of Research-Development for Microbiology and Immunology "Cantacuzino", Bucharest, Romania.
Insights
This study compared two tuberculins, RT23 and IC-65, in children with tuberculosis. Both tuberculin skin test reagents demonstrated equivalent biological potency and high sensitivity for diagnosing tuberculosis.
Area of Science:
- Immunology
- Infectious Diseases
- Public Health
Background:
- Tuberculosis (TB) diagnosis relies on accurate tuberculin skin testing (TST).
- Comparing the biological potency of different tuberculin reagents is crucial for reliable TB screening.
- RT23 and IC-65 are commercially available purified protein derivative (PPD) tuberculins used in TB diagnostics.
Purpose of the Study:
- To evaluate and compare the biological potency of two tuberculin reagents, RT23 and IC-65.
- To assess the efficacy and sensitivity of RT23 and IC-65 in diagnosing tuberculosis in children.
Main Methods:
- A comparative study involving 89 children with confirmed tuberculosis.
- Simultaneous administration of RT23 and IC-65 tuberculins using the Mantoux method at a concentration of 2 tuberculin units (TU)/0.1 ml.
- Measurement and statistical analysis of tuberculin skin test reaction sizes.
Main Results:
- Tuberculin skin test reactions for RT23 ranged from 8-18 mm (mean 12.8 mm), and for IC-65 ranged from 8-18 mm (mean 13.1 mm).
- No statistically significant difference was found in the mean reaction sizes between RT23 and IC-65 (P=0.3).
- Both tuberculins showed high sensitivity (RT23: 98.9%, IC-65: 97.8%) with a 10 mm cutoff, indicating comparable diagnostic accuracy.
Conclusions:
- RT23 and IC-65 exhibit equivalent biological potency and efficacy in diagnosing tuberculosis.
- The findings support the use of both RT23 and IC-65 as reliable reagents for tuberculin skin testing in pediatric TB cases.
- This study confirms the comparable performance of these two PPD TST reagents.
Abstract:
This study, conducted in 2009, proposed to evaluate and compare the biological potency of two different tuberculins, RT23 (Statens Serum Institute, Copenhagen) and IC-65 (Cantacuzino Institute, Bucharest) when administered to 89 children with confirmed tuberculosis, admitted to Paediatric Department of Pneumophtysiology Institute, Bucharest. Mean age of subjects was 10.4 years [SD (standard deviation) = 5.2 years; variance = 27.2], and sex distribution in the group was: 55.1% girls and 44.9% boys. Tuberculin skin tests were performed using Mantoux method simultaneously with the two tuberculins in the same concentration, 2TU (tuberculin units)/0.1 ml. RT23 skin test reactions ranged from 8 mm to 18 mm (mean = 12.8 mm, SD = 2.1 mm, variance = 4.4; median = 12.0), and IC-65 reactions ranged from 8 mm to 18 mm (mean = 13.1 mm; SD = 2.1 mm; variance = 4.3; median = 13.0). The mean difference in paired reaction sizes for the two reagents was 0.04 mm and was not statistically different from zero (P value = 0.3). The difference in reaction sizes was = 2 mm in 70.8% and = 5 mm in 7.9% patients. With a cutoff of 10 mm to define a positive reaction, the results were highly correlated with a sensitivity of 98.9% for RT23 and 97.8% for IC-65. No statistically significant difference was established for the efficacy of the two commercially available PPD TST reagents, both tuberculins appearing to have equivalent potency.
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