Diaskintest

Yohhei Hamada

TB/HIV and Community Engagement Unit

Global TB Programme, WHO

Diaskintest (DST)

A skin test using CFP10-ESAT6,

produced by Echerichia coli

BL21(DE3)/pCFP-ESAT.

Manufactured by Generium in Russia.

Since 2009, more than 20 million tests

have been performed in Russia,

Kazakhstan, Ukraine, Belarus, Kirgizstan,

and Turkmenistan. (Source: http://www.generium.ru/en/products/diaskintest/)

Database:

Pubmed, Global Health Library, google scholar, and google.

UNION and ERS conference abstracts in the past 5 years.

Pubmed: 7 articles in Russian.

14 abstracts at the ERS congress and 5 at the UNION.

3 English articles published in non-Medline journals.

Literature review of Diaskintest

Starshinova et al. International Journal of Medical Sciences and Biotechnology. 2013; 1(5) ; 38-45

Yablonsky et al. International Journal of Biomedicine. 2012; 2(3); 204-210

Pavlova et al. Online International Interdisciplinary Research Journal, 2014; 4(5); 7-13

Comparison with TST (1)

16.9

3.5

80

Diaskintest

Diaskintestpositive

doubtful

negative

Diaskintestpositive

doubtful

negative

Children with active TB Healthy children

Korneva et al. ERS congress 2013

249 children (3-14 yrs) between 2009-2011 in Russia. (BCG coverage >90%)

Sensitivity: 93.4% vs 80% Specificity: 20% vs 59%

59

15.7

25.3

Diaskintest

6.6

93.5

0%

20%

40%

60%

80%

100%

TST

20

80

0%

20%

40%

60%

80%

100%

TST

>=10mm

<10mm

>=10mm

<10mm

Higher specificity than TST

Mantoux-positive

1 064 731 (74.5%)

DST-positive – 5 784 (3.0%)

Screening with Mantoux test

2015Examined by the Mantoux:

1 430 047

Examined by the DST

195 254 (12.9%)

Slogotskaya et al. ERS congress 2016

• 1,260,389 children and 169,658 adolescents tested by TST for mass screening in Russia.

• BCG coverage >90%

Comparison with TST (2)

DST positive in only

3% of TST-positives

who were BCG

vaccinated

Slogotskaya et al. ERS congress 2016

Comparison with IGRA (T-SPOT)

159 BCG-vaccinated children (2-14 yrs) with a positive TST result.

Diaskintest

T-SPOT

Negative

(n=128)

Doubtful

(n=8)

Positive

(n=23)

Negative (n=148) 128 7 13

Indeterminate (n=2) 0 1 1

Positive (n=9)

0 0 9

Concordance rate: 87%; Kappa: 0.454 (95%CI: 0.274-0.634)

High concordance rate compared with T-SPOT

Starshinova et al. ERS congress 2013

Comparison with IGRA (QFT-Gold) (1)

77 BCG-vaccinated children (3-14 yrs) tested by TST in Russia

28.6 14.3

71.4 85.7

0%

20%

40%

60%

80%

100%

DST QFT-Gold

73.5 75.5

26.5 24.5

DST QFT-Gold

80.9 71.4

19.1 28.6

DST QFT-Gold

TST>15mm TST 10-15 mm TST <10mm

Positive Negative

Similar reaction pattern compared with QFT-Gold

Slogotskaya et al. ERS congress 2016

Comparison with IGRA (QFT-Gold) (2)

120 BCG-vaccinated Children (3-14 yrs).

Children were sent for investigation due to a positive TST (n=80),

contact with TB (n=35), and clinical complaint (n=5).

Diaskintest

QFT-Gold

Negative

(n=58)

Doubtful

(n=6)

Positive

(n=56)

Negative (n=69) 57 6 6

Indeterminate (n=1)

0 0 1

Positive (n=50)

1 0 49

Concordance rate: 88%; Kappa: 0.779 (95%CI: 0.676-0.881)

High concordance rate compared QFT-Gold

Performance of Diaskintest in patients with HIV

88 patients with HIV-associated TB

Diaskintest positive: 60.2% (mean CD4: DST + 392; DST-195)

257 TB patients including 42 PLHIV

Diaskintest positive: 78.1% in HIV- and 52.4% in HIV+

Slogotskaya et al, ERS congress 2013

Pnakratova et al, ERS congress 2013

Lower sensitivity in people living with HIV with

lower CD4 counts

Predictive performance for development of

active TB

80 children (3-14 yrs) diagnosed with LTBI by a postitive

TST result and chest CT findings (criteria not defined) in

St. Petersburg, Russia. Followed up for 12 months.

32 (37.3%) received INH+PZA for 3 months.

DST reaction size Incident TB Risk ratio

<10mm 3/11 (27.3%) Reference

10-14mm 15/24 (62.5%) 2.3 (0.83-6.3)

>=15mm 33/45 (78.6%) 2.7 (1.0-7.2)

Korneva et al. ERS congress 2015

2 times higher risk of developing active TB in DST

positives compared to negatives

Correlation with disease activity?

N Treatment

duration (days)

Positive Diaskintest reaction

n % 95%CI

497 1-30 425 85,1 82,1-88,4

112 100-120 61 54,5 45,2-63,4

595 1 year after completed treatment

61 10,3 8,1-13,0

Thus, we could judge the process dynamics, p<0.001. Slogotskaya et al, ERS congress 2013

DST positive rate in pulmonary TB patients

Lower DST positive rate in those who have completed

TB treatment

Conclusions

Very limited data reported in English literature

and most data are among children and

adolescents.

Diaskintest appears to have higher specificity

than TST and similar performance to IGRA in

BCG-vaccinated children.