ichromaTM IGRA-TB

Novel POC Test for Latent TB Diagnosis

While the COVID-19 pandemic, it has significantly increased
the potential severity of uncontrolled TB

Innovative technological advance

Fluorescent Immunoassay based on lateral flow.

Objective
Unlike TB skin test, ichromaTM IGRA-TB is a controlled and objective assay.

Single visit test

ichromaTM IGRA-TB requires only one visit for patient.

Effective in BCG-vaccinated patients

Unaffected by BCG vaccination.

No waste
ichromaTM IGRA-TB is a single cartridge based test, thus no wasted well.

Watch Video https://youtu.be/qe7eoY2GdqU

Health officials are paying attention to respiratory infections
that have similar symptoms to those of COVID-19.

TB Disease: Only the Tip of the Iceberg [1]

Tuberculosis (TB) is the leading cause of death from a single infectious disease worldwide to the
extent that WHO recommends the development of cost-effective diagnostics to eradicate latent TB
(90%, undiagnosable), which underlies active TB (10%, diagnosable).

People with TB disease are sick

from active TB germs. They usually
Active TB have symptoms and may spread
(only 10%) TB germs to others.

Contagious

People with latent TB infection do not

feel sick, do not have symptoms, and
Weakened
cannot spread TB germs to others.
immunity

But, if their TB germs become active,

they can develop TB disease.
LTBI (90%)
Latent TB infection Non-contagious
(modified the CDC's infographic; https://www.cdc.gov/tb/publications/infographic/default.htm)

Current TB can increase COVID-19 mortality [2]

Active TB The current COVID-19 pandemic has collapsed near the 80% of
Real Risk & Mortality
global control for tuberculosis (TB), and sooner or later, the fatal risk
Coinfection of TB outbreak and co-infection with COVID-19 will act as a global
double burden.

TB SARS-CoV-2
aHR=
aHR=

TB germs is
2.7 aHR=
2.14
activated & grows
1.51
Current TB Previous TB HIV
* aHR: adjusted hazard ratio

TB increased the risk of COVID-19 more than 1.5-fold, even

in those who had recovered from TB already compared to
Incidence

2.7-fold in current TB. [3]

In the COVID-19 pandemic, children will be the biggest victims of

Latent TB respiratory infections and tuberculosis.
Potential risk
ichromaTM IGRA-TB
Affordable and Accessible Test for Latent TB diagnosis

How the COVID-19 Pandemic Exacerbates the Tuberculosis Outbreak

; dual burden of TB & COVID-19 [4-8]

Public health & socioeconomic exhaustion

Promote reactivation of latent TB to active TB
The collapse of essential TB treatment & services
Significant increase in the biological and clinical risk of co-infection
Misdiagnosing or missing each other for COVID-19 or tuberculosis, and coinfection.

Comparisons of IGRA tests for diagnosis of Latent TB

Despite the improved performances compared to the Tuberculin skin test (TST), of the past, current
IGRA tests, either ELISpot or ELISA methods, are cumbersome, inefficient, and uneconomical. [9]

IGRA tests
TST * RDT
ELISpot ELISA (Fluorescent-LFIA)

ichromaTM IGRA-TB
Commercial products - competitor O competitor Q
(Boditech Med)

Standard curve for Yes Yes No needed

None
Calibration For every test For every test presaved in ID-chip

Test substrate Skin Purified PBMC Whole blood Whole blood

Time required
~ 20 h ~ 20 h ~ 20 h
Incubation (CMI)
72 h
Time required for
4h 3~4 h 15 min
Result (IGRA)

Read-out units mm (milimeters) IFN-r spot forming cells IU/mL IU/mL

Equipment None ELISpot reader ELISA reader ichromaTM Readers

Very low sensitivity

Performances Sensitivity QTF-IT/plus Specificity ELISpot Comparable to QTF-TB
and specificity

Requirement of trained
Staff (proficiency) Highly trained Highly trained trained Anyone

Storage condition 2~8℃ (cold chain) 2~8℃ (cold chain) 2~8℃ (cold chain) 4~30℃ (20 Months)

Price/test Cheaper appropriate

expensive very expensive
(about 1/10 of ELISA) & economical

* Tuberculin skin test (TST)

ichromaTM IGRA-TB
Cost-effective POC Test for Latent TB Diagnosis

All-inclusive kit & No hidden cost

We offer the ichromaTM IGRA-TB, POC-type IGRA diagnostics, at a lower price than ever before, with
standardized and faster results, more accurate and reliable clinical performances, and improved ease
of use for laboratories without expertise.

Cost

$$$ ELISA plate

Cost-effectiveness
Standard curve 100
80
No Hidden cost
Blood tube 60
40
Cal/QC Fast results Easy to use
20
$$
0

ELISA reader
$$
Sensitivity Reproducibility

ichromaTM IGRA-TB Competitor Q ichromaTM IGRA-TB ELISA

TRF-FIA ELISA

Affordable and Accessible Test for Latent TB diagnosis

T IFN-r
C

With IGRA in the same Without consuming Even one patient Quick results in 15 min
mechanism (CMI) as before calibration process

Clinical performance
Comparator A
Total
Positive Negative
Positive 102 6 108
ichromaTM IGRA-TB
Negative 23 232 255
Total 125 238 363

PPA (%) 81.6% (95% C.I. 73.9 ~ 87.4%)

NPA (%) 97.5% (95% C.I. 94.6 ~ 98.8%)

OPA (%) 92.0% (95% C.I. 88.8 ~ 94.4%)

Cohen's kappa (κ) 0.817 (95% C.I. 0.754~0.881) ; "Very good" agreement

* This data was used to obtain approval for domestic use from South Korea Ministry of Food and Drug Safety (MFDS, Korean FDA).
Specification
Product Name ichromaTM IGRA-TB ichromaTM IGRA-TB 25
Assay type TRF-LFA

Sample type Plasma (available Heparin only)

Sample volume 50 µL

Assay time 15 min

Storage 4-30℃ (up to 20 months)

300 Cartridges 150 Cartridges

Box contents (Unit) 300 Blood collection tubes 150 Blood collection tubes
(Nil, TB-Ag, & Mitogen tubes are 100 each) (Nil, TB-Ag, & Mitogen tubes are 50 each)

Platform ichromaTM-50 ichromaTM II, ichromaTM III

Ordering Information
ichromaTM II FPRR021 Set

ichromaTM III FPRR037 Set

Boditech IGRA-TB control (CFPC-294) is traceable
ichroma -50TM
FPRR022 Set
to 1st WHO International standard (human IFN-r,
ichromaTM IGRA-TB CFPC-86 300T/Box
#Gg 23-901-530); Not included.
ichromaTM IGRA-TB 25 CFPC-86-1 150T/Box

Boditech IGRA-TB control CFPC-294 Set

Procedures

1 Dispense venous blood into culture tubes 2 Incubate for 20±4 hours 3 Centrifuge for 10 minutes

10 min
37℃
NiL TB Mito
Each 1 mL (N TB M)

&

4 Interferon gamma release 4 Interferon gamma release assay (IGRA)

assay (IGRA)

OR
 Platform Selection Guide & Applicable Cartridge Packages

Cartridge?

All-in-one Single

Prefer single test? Throughput?

Yes No High Medium

Tube blood? Temperature

control?
No Yes
No Yes

1 Bay 2 Bay

Cartridge pack##CFPC-86-1
Cartridge pack CFPC-86-1
150 tests
150 tests for
for50
50patients
patients

Cartridge pack # CFPC-86

New AFIAS IGRA-TB is coming soon 300 tests for 100 patients

References
1) Tuberculosis; the fact sheet. (Oct. 14, 2020). https://www.who.int/news-room/fact-sheets/detail/tuberculosis
2) Gopalaswamy R and Subbian S. Corticosteroids for COVID-19 Therapy: Potential Implications on Tuberculosis (2021). Int J Mol Sci. 22: 3773. doi: 10.3390/ijms22073773. PMID: 33917321
3) Boulle A et. al., Risk factors for COVID-19 death in a population cohort study from the Western Cape Province, South Africa (2020). Clin Infect Dis. :ciaa1198. PMID: 32860699; PMCID:
PMC7499501.
4) The potential impact of the covid-19 response on tuberculosis in high-burden countries: A modeling analysis (WHO World Stop TB report, May 6, 2020)
http://www.stoptb.org/assets/documents/news/Modeling%20Report_1%20May%202020_FINAL.pdf
5) Aznar ML et. al., Impact of the COVID-19 pandemic on tuberculosis management in Spain (2021). Int J Infect Dis. 108:300. doi: 10.1016/j.ijid.2021.04.075. PMID: 33930543
6) Saunders MJ and Evans CA. COVID-19, tuberculosis and poverty: preventing a perfect storm (2020). Eur Respir J. 56:2001348. PMID: 32444399. doi:10.1183/13993003.01348-2020
7) Gopalaswamy R and Subbian S. Corticosteroids for COVID-19 Therapy: Potential Implications on Tuberculosis (2021). Int J Mol Sci. 22: 3773. doi: 10.3390/ijms22073773. PMID: 33917321
8) Chan Y et. al., Active or latent tuberculosis increases susceptibility to COVID-19 and disease severity (2020). medRxiv. doi: https://doi.org/10.1101/2020.03.10.20033795
9) Mack U et. al., LTBI: latent tuberculosis infection or lasting immune responses to M. tuberculosis? A TBNET consensus statement (2009). Eur Respir J. ;33: 956-73. doi:
10.1183/09031936.00120908. PMID: 19407047.

Boditech Med ichromaTM IGRA-TB in Articles

Hur YG et. al., A Feasibility Study for Diagnosis of Latent Tuberculosis Infection Using an IGRA Point-of-Care Platform in South Korea. Yonsei Med J. 2019. 60:375-380. doi:
10.3349/ymj.2019.60.4.375. PMID: 30900424.
EN_Rev00_ichroma IGRA-TB_20210910_6P

Hamada Y, et. al., Tests for tuberculosis infection: landscape analysis. Eur Respir J. 19:2100167. 2021. doi: 10.1183/13993003.00167-2021. PMID: 33875495.
Lee HH et. al., Evaluation of a lateral flow assay-based IFN-γ release assay as a point-of-care test for the diagnosis of latent tuberculosis infection. Clin Rheumatol. 2021. 40:3773-3781.
doi: 10.1007/s10067-021-05663-1. PMID: 33666781.
Kweon OJ et. al., Performance evaluation of newly developed fluorescence immunoassay-based interferon-gamma release assay for the diagnosis of latent tuberculosis infection in
healthcare workers. J Microbiol Immunol Infect. 2021. S1684-1182(21)00104-3. doi: 10.1016/j.jmii.2021.05.007. PMID: 34127404.
Migliori GB et. al., The definition of tuberculosis infection based on the spectrum of tuberculosis disease. Breathe 2021; 17: 210079. DOI: 10.1183/20734735.0079-2021.
WHO Global Tuberculosis Report (2020), p 179 FIG. 9.2 An overview of progress in the development of TB diagnostics, August 2020.
https://apps.who.int/iris/bitstream/handle/10665/336069/9789240013131-eng.pdf

43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gangwon-do, 24398, Korea

Tel: +82-33-243-1400 / Fax: +82-33-243-9373 / sales@boditech.co.kr / www.boditech.co.kr