afias 6 (automatic fluorescence...

AFIAS 6 (Automatic Fluorescence Immuno-Assay)

Each SMART kit contains ten (10) cartridges, one (1) ID Chip, and one (1) instruction for use

AFIAS 6 (Automatic Fluorescence Immuno-Assay) is a next-generation, full-automatic, desktop fluorescence processing and scanning instrument for measuring the concentration of target analytes in human blood, urine and other specimens in various specially designed cartridges, which will be properly processed and tested in accordance with ichroma™ SMART Immunoassay.

HQs, Boditech Med, Inc.South Korea

Company At a GlanceBoditech Med, Inc. was founded by Dr. Eui Yul Choi, an entrepreneur scientist whose mission is to make diagnostics affordable and accessible to everyone and help them to lead a happy and healthy life. Since the inception of the company in 1998, it has expanded its business in over 80 different countries with two main products; ichroma™ and Hemochroma plus.

With our innovative technology, we have achieved No. 1 position in China on a single reagent basis since 2011. We have also formed a partnership with a top healthcare company in India and will continue its fast growth over the next decades. Boditech Med, Inc. aims to become a world’s top 10 in vitro diagnostic com-pany in 2014. To do so, we will make incessant efforts to offer innovative and affordable products including the ichroma™ SMART, a semi-automatic analyzer in 2013 and more disease markers to the global market.

ichroma™ is a portable diagnostic system using a fluorescence immunoassay that quantifies analytes by measuring laser-induced epifluorescence of test strips. ichroma™ technology utilizes a lateral flow-type assay method in which the labeled antibody bound in analytes is captured while migrating through the nitrocellulose membrane.

The system consists of a fluorescence reader and test cartridges. It can be used to screen a variety of diseases, such as cardiovascula diseases, cancers, diabetes, infectious diseases and hormonal disorder. Our continuous efforts with product innovation enabled us to introduce the world’s first TSH and hCG diag-nostic tests using whole blood in 2012. All of ichroma™ tests are CE-certified, while ichroma™ reader and CRP are FDA approved.

Technology

Multi Single

SpecificationDimensionsWeightData storage

DisplayInterface

697 mm (W) x 553 mm (L) x 528 mm (H)42 kg1,000 Test

Data output LCD/Thermal Printer

LCD (800 x 480 graphic LCD)

RS232, LAN, USB, touch screen, Built-in printer(optional; Barcode scanner, keyboard)

SpecificationDimensionsWeightData storage

DisplayInterface

210 mm (W) x 308 mm (L) x 398 mm (H)6.78 kg1,000 Test

Data output LCD/Thermal Printer

LCD (800 x 480 graphic LCD)

RS232, LAN, USB, touch screen, Built-in printer(optional; Barcode scanner, keyboard)

Comming SoonTn-I , CK-MB, Myoglobin, AFP, CEA, iFOB, HbA1c, Microalbumin, T4, hCG, Testosterone, Cortisol, RF IgM, Ferritin

Cardiac

All tests give quantitative results and are CE-marked.

Tumor

Hormone

Infection

Product class Diseases Sample type Reaction timeTest item

Plasma

Whole blood, Serum, Plasma






Whole blood



D-Dimer

CRP

FSH

hsCRP

LH

PCT

PRL

PSA

TSH

Total βhCG

12 min.

3 min.

15 min.

3 min.

15 min.

12 min.

10 min.

15 min.

12 min.

15 min.

Blood clotting

Cardiovascular Inflammation

Prostate Cancer

Infertility / Menopause

Sexual Disorder

Infertility / Ovulation

Fertility

Thyroid Function

Inflammation

Sepsis

Measurement ranges

50-10,000 ng/mL

0.5-100 ng/mL

1-100 ng/mL

0.1-100 ng/mL

0.1-10 mg/L

2.5-300 mg/L

1-100 μIU/mL

3-100 mlU/mL

5-100 mlU/mL

5-50,000 mlU/mL

Test available

Immunological assaySample volume: 5 µlPre-incubation time: 5-30 min.Reaction time: 12 minutesMeasurement range: 4-15%Display: % of HbA1c & Hemoglobin concentrationNGSP certified

Description: New HbA1c test

Enhanced Reliability & Reproducibility with

New HbA1c Test

is a thermostatic attachment to -CHRO

MATM designed for HbA1c test.

pre-conditions HbA1c test strips for

accurate and reproducible results.

16.0

14.0

12.0

10.0

8.0

6.0

4.0

2.0

0.00.0 2.0 4.0 6.0 8.0 10.0 12.0 14.0 16.0

y = 0.9939x + 0.0038R2 = 0.9835N = 150

HbA1c(%)

Toso

h G

7 HPL

C H

bA1c

(%)

HbA1c vs Tosoh G7

Go to www.boditech.co.kr for more information. Contact us: [email protected]

REV. 28_2015_04_13

43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, 200-883, KOREA

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

Boditech Med Inc.

•Principle: Fluorescence immunoassay •Detection range: 0.1-100 ng/mL•Cut-off: 0.5 ng/mL•Samples: Whole Blood, Serum, plasma•Test time: 12 minutes•Analyzer: ichroma™ Reader, ichroma SMART

PCT Quantitative Assay: Fast & Accurate

ichroma™ PCT is a fluorescence immunoassay for quantitative determination of procalcitonin (PCT) in human serum and plasma. PCT is known as a useful marker in the diagnosis of bacterial infection and sepsis. Sepsis is a life-threatening condition that arises when the body's immune response to an infection damages its own tissues and organs. Sepsis is the leading cause of death from infection around the world, which lead millions of people around the world to death every year.

The value obtained by ichroma™ PCT is comparable to that of high-end machine.

PCT is a better biomarker for sepsis than others.

PCT

1.00

Sen

siti

vity

1-Specificity

0.75

0.50

0.25

0.00

1.000.750.500.250.00

Description

PCT levels accurately differentiate sepsis from noninfectious inflammation.

PCT has been demonstrated to be the best marker for differentiating patients with sepsis from those with systemic inflammatory reaction not related to infectious cause.

Ref. Simon L. et al. Clin Infect Dis. 2004; 39:206-217.

•

•

Comparability

y = 0.9958x + 0.054 R = 0.9981 N = 74

2

120.00

100.00

80.00

60.00

40.00

20.00

0.00

0.00 20.00 40.00 60.00 80.00 100.00 120.00

Roche Cobas e411 PCT [ng/mL]

ichr

oma

SM

ART

PCT

[ng/

mL]

TM

Inter-assayPCT Intra-assay

Avg.Con. (ng/mL) CV%

0.120.1 3.87

2.002.0 2.58

99.15100 1.49

SD

0.00

0.05

1.48

Avg. CV%

0.12 6.78

2.01 1.47

99.80 0.94

SD

0.01

0.03

0.94

Test Markers

Local Distributor43, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, Gang-won-do, 200-883, KOREA Tel +82-33-243-1400 Fax +82-33-243-9373 Email: sales@boditech. co.kr Website : www.boditech.co.kr

Boditech Med Inc.

All tests are quantitative and CE-marked

Cardiac

Cancer

Diabetes

Hormone

Infection

Rheumatoid Arthritis

Others

0.5-100 ng/mL0.1-100 ng/mL

0.4-100 μIU/mL0.05-50 μIU/mL0.5-5.0 ng/mL

(0.77-7.7 nmol/L)

0.1-50 ng/mLSerum, Plasma

Whole bloodSerum, Plasma








Product class Diseases Sample type Reaction time Measurement rangesTest item

15 min.

12 min.

15 min.

15 min.

15 min.

15 min.

0.1-100 μIU/mL

1-100 μIU/mL

2-3,000 mlU/mL

Serum, Plasma

Plasma

Serum, Plasma

Serum, Plasma

Serum, Plasma

Serum, Plasma


Serum, Plasma

Serum, Plasma

Serum, Plasma

Serum, Plasma


12 min.

12 min.

12 min.

12 min.

3 min.

15 min.

15 min.

12 min.

12 min.

12 min.

10 min.

10 min.

3 min.

5 min.

12 min.

12 min.

10 min.

10 min.

10 min.

3-100 ng/mL

50-10,000 ng/mL

5-500 ng/mL

0.1-10 mg/L

5-350 ng/mL

1-500 ng/mL

25-1,000 ng/mL

4-15 %

2-300 mg/L

20-300 nmol/L

1-100 mlU/mL

5-50,000 mlU/mL

1-100 mlU/mL

1-100 ng/mL

1-10 ng/mL

80-800 nmol/L

2.5-300 mg/L

0.1-100 ng/mL

10-200 lU/mL

25-800 lU/mL

10-1,000 ng/mL

Whole blood

Myocardial infarction



Thrombosis

Cardiovascular inflammation

Prostate cancer

Liver cancer

Cancers

Coloerctal cancer

Diabetes mellitus

Diabetes mellitus

Thyroid malfunction

Thyroid malfunction

Thyroid malfunction

Menopause/infertility

Pregnancy

Fertility

Ovulation

Sexual disorder & infertility

Sexual disorder

Metabolism

Inflammation

Sepsis

Rheumatoid Arthritis

Anemia

Tn-I

CK-MB

D-Dimer

Myoglobin

hsCRP

PSA

CEA

AFP

iFOB

HbA1c

Microalbumin

TSH

TSH WB

T4

Serum, Plasma 16 min.Thyroid malfunctionT3

Whole bloodSerum, Plasma 15 min.Thyroid malfunctionTSH Plus

FSH

hCG

15 min.1.4-40 ng/mL

(4.45-127.2 nmol/L)Serum, PlasmaFertilityProgesterone

βhCG

LH

PRL

Testosterone

Cortisol

CRP

PCT

RF IgM

Ferritin

Serum, Plasma 12 min.Rheumatic feverASO

Feces (stool)

Urine

10 min. 0.1-7.5 mg/LRenal diseaseCystatin C Serum, Plasma

Whole blood

Markers coming soon: Vitamin D, NT-pro BNP, HbsAg, Total IgE and more

afias 6 (automatic fluorescence...

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