Company & Products Introduction - MEDICA · 2020. 12. 1. · Company NameOptibio Co., Ltd. Date of...

Company &Products Introduction

The Global Leader of Optic Technology & N.B.IT Convergence Technology

Contents

Company Profile Technology Products Market & Business

01Profile

Optibio Co., Ltd.Company Name

June, 2018Date of Establishment

Researching & Development, Manufacturing, Sales

Immunofluorescence Quantitative POCT Medical

Equipment

Business Area

Chungbuk TP bonbukwan-409, 76, Yeongudanji-ro,

Ochang-eup, Cheongwon-gu, Cheongju-si,

Chungcheongbuk-do, Republic of Korea

Address

In vitro diagnostic that can quantitatively analyze various biomarkers using

fluorescent material by using antigen-antibody reaction

IFA (Immunofluorescence assay)

In vitro diagnostic which enables quick visual analysis by using color reaction of

gold nano bead

RDT(Rapid Diagnostic Test)

Supplying small-sized analyzers for various in vitro diagnostic reagent companies

without equipment production technology

IVD-Instrument

Global IVD Company

Company Overview

VisionA global leader in promoting healthy life through technology

We hold a sense of duty and

responsibility towards the health

and happiness of our customers

Responsibility

We are constantly striving to

create new possibilities for our

customers.

Possibility

We will not only challenge ourselves

but also the market status quo, to

ultimately encourage innovation and

better solutions.

Challenge

We strive to realize

the dream of human society.

Co-exist

Chart

AuditorPresident/CEO

Develop Div.BusinessDiv. Production Eng. Div.Management

Support Div.Q/A

Quality Control

Instrument

Development

Reagent

DevelopmentBusiness StrategyAccount

HRM

A/S

Sales

ProductionBusiness PlanningGeneral Affairs Quality Control

BOD

(Board of Directors)

History &

2019.10 2019.10 2019.11 2019.12 2019.12 2019.12 2020.04 2020.06 2020.07

Factory registrationCompany affiliated research

institute certificate

Medical device manufacturing

licenseEMC certificate EC certificate

Regional flagship

development project

RoHS ISO13485 GMP

• Optical module production

• Diagnostic kits production

• Diagnostic medical device

production

GMP/ISO13485

Facility

Production

• Optical design technology

• Optical instrument design

technology

• Optical module development

• Development of optical module for

machine vision

• Diagnostic medical equipment

development

• Antigen

• Antibody development

• Nano metal synthesis

• Fluorescent material synthesis

• Development of diagnostic

kit/reagent

Device Laboratory Reagent Laboratory

Research & Development

02Technology

Convergence TechnologyOptics-based ICT Technology + Antibody-based Bio Technology

Optical Core Technology

• Unique optical lens and optical instrumentdesign technology

• Optical lens assembly and align technology

• Detected signal processing and quantification

Bio Core Technology

• Development of genetic engineering based raw materials for

biotechnology

• Synthesis between fluorescent materials, nano metal materials, and bio

raw materials

• Technology of developing and manufacturing of qualitative and

quantitative diagnostic kit

Optics(H/W & S/W) Mechanic(H/W) Analysis (S/W) Bio Materials Dye Conjugation Diagnostic Kit

& Analyzer development

Sample pad

Detection Antibody

Capture Antibody

Fluorescence–conjugated Antibody and Antigen

Antigen

Fluorescence Substance

Absorbent pad

Lateral flow

Results[LCD or Printer]

Analysis

Optical Q：Immunofluorescence Analzyer

Quantitative signal measurement sensor Analysis of algorithms

Analysis signal according to fluorescence intensity

Multiple signal processing algorithms

Noise signal processing algorithm

※We also provide instrument development service

Antibody developmentDevelopment of diagnostic rare antibody: Vitamin D Antibody

The only vitamin that can be synthesized in the body

Vitamin D3 (Cholecalciferol)

Why vitamin D antibody development is difficult

• It is a substance present in all animals and plants, so it has no immunogenicity.

• The primary metabolite, 25-OH VitD, is a small compound that is not a macromolecule such as a

protein.

• It is necessary to obtain antibodies that recognize various hydroxyl groups of the VitaminD

molecule.

Possesses serum free suspension culture based antibody manufacturing technology

• Bioreactor-based mass

production such as antibody

drugs

• Completion of development of an premature birth

diagnosis kit that can ensure homogeneity of the raw

material for antibody

1,000 mice 50L Bioreactor

Company A

Company B

OptiBio 2E4-B3-9

OptiBio 2E10-O4-1

The sensitivity of OptiBio’s Vitamin D is 2 times higher than other companies in the general dectectionrange 10 to 50 ng/mL

• Development of ultra-high-level antibodies requires a high level of knowledge and experience in epitope design, adjuvant combination, antigen dose and dosing schedule.

• As shown in the figure above, OptiBio has completed the development of antibodies with a sensitivity that is more than twice as high as those sold by large antibody development companies, and has a strong competitive

advantage over global company in the production cose.

Antibody developmentDevelopment of a new concept of diabetes poct diagnosis technique

Existing glycated hemoglobin measurement method

Diabetes is diagnosed when the level is over 6.5%

The existing method has the disadvantage that when performing the blood pretreatment

process, there is no change in the denominator(total hemoglobin), but the change

in the numerator(glycosylated hemoglobin) is severe

Many errors in the same blood test

Glycated hemoglobin level = Anti-HbA1c

Anti-Hb

Measurement of glycated hemoglobin in development

Because the new method of OptiBio checks for glycosylation of the same site regardless of the

blood pretreatment process, the variance of the denominator (total hemoglobin) and molecule

(glycosylated hemoglobin) changes at the same rate.

Minimizes errors in the same blood test

Glycated hemoglobin level = Anti-HbA1c

Anti-HbA1cN

03Products

Analyzer

Manual Type System for Immunofluorescence Strip Analyzer

Optical Q

• Embedded Operation System

• Measurement “Photo Diode”

• Light Source “Laser”

• Filter “Excitation 650 / Emission

680”

• Type of measurement “Scanning

by step-motor”

• Compact Design

Specification

Dimensions 357 mm (L) x 284 mm (W) x 156 mm (H)

Weight 1.5 kg

Power supply DC 12V/5A, AC/DC Adaptor

Data output LCD / Internal printer

Memory 99 Patient results

Interface RS422 (RJ45) / mini 5pin / USB

Display LCD 5" Mono LCD

Workingcondition

Temperature: 2 ~ 30°CHumidity: 10 ~ 70%

Easy to

Use

Fast

Result

Internal

Printer

Barcode RFID

POCT Reagents

High-Sensitivity immunofluorescence diagnostic System

Optical Q

“ Optical Q ” is a Point of Care Test (POCT) immunofluorescence diagnostic system,

which can be used to obtain diagnostic results within 3 to 15 minutes, using various

samples such as serum, plasma, whole blood, and urine. Our immunofluorescence

diagnostic system, which is 10~100 times more sensitive than the existing ‘Gold Rapid’

test method, can not only obtain quantitative results with higher accuracy but also

cover a wider range of tests.

TSH

Total T3

Free T3

Total T4

Free T4

betahCG

LH

FSH

Testosterone

Progesterone

Cortisol

Prolactin

AFP

CEA

PSA

i-FOB

CRP

PCT

TnI

CK-MB

Myoglobin

NT-proBNP

D-dimer

hsCRP

IL-6

IL-8

MMP-8

HbA1C Vitamin D

Ferritin

Tumor Hormone Cardiac Inflammation Diabetes Prematurity Others

Test

1. Power on

2. Enter ‘Test’

3. Enter ‘Read ID Card’

4. Read ‘RFID Card’

CRP: 10㎕

FT3: 200㎕

Others: 100㎕

Mix the specimen in the detection buffer tube.

Shake the mixture tube about 10 times.

Load 100㎕ of mixture into the sample well on the test cartridge.

※ Do not draw the sediment CRP: 3 mins

Others: 15 mins

Incubate the sample-loaded test cartridge at the room temperature for several mins.

After incubating, insert the test cartridge into the OpticalQ analyzer for checking the test result.

030201

060504

Inflammation -C-Reactive Protein (CRP) Test

C-reactive protein (CRP) is a protein made by the liver. CRP levels in the blood increase when there is a condition causing

inflammation somewhere in the body.

A CRP test measures the amount of CRP in the blood to detect inflammation due to acute conditions or to monitor the severity

of disease in chronic conditions.

Inflammation

• To identify the presence of inflammation

• To monitor response to treatment for an inflammatory disorder

Why Get Tested?

• When your healthcare provider suspects that you have an acute condition

causing inflammation, such as a serious bacterial or fungal infection

• When you are suffering from an inflammatory disorder such as arthritis, an

autoimmune disorder, or inflammatory bowel disease

When To Get Tested?

,

Specification

Working range 0.1 – 300 ng/L

Reference range 10 ng/L

Sample type Whole blood / Serum / Plasma

Sample volume 10 μL

Loading volume 100 μL

Assay time 3 mins

Storage conditionCartridge: 4-30 ℃ / Detection

buffer: 2-8 ℃

Shelf life 24 months

Inflammation -Procalcitonin (PCT) Test

Procalcitonin is a substance produced by many types of cells in the body, often in response to bacterial infections but also in response

to tissue injury. The level of procalcitonin in the blood can increase significantly in systemic bacterial infections and sepsis. This test

measures the level of procalcitonin in the blood.

Specification

Working range 0.1 – 100 ng/mL

Reference range 0.5 ng/mLt

Sample type Serum / Plasma



Assay time 15 mins


buffer: 2-8 ℃


• To help diagnose sepsis if you are critically ill;

• To help determine your risk of progressing to severe sepsis and septic shock;

• To help identify serious bacterial infections and to distinguish between bacterial

and non-bacterial conditions;

• To help guide antibiotic treatment

Why Get Tested?

• When you are seriously ill and have signs and symptoms of a systemic infection

or sepsis;

• When you have signs and symptoms that may be due to a bacterial infection and

your healthcare practitioner wants to determine whether antibiotics would be

effective;

• When practitioner needs to administer antibiotics at intervals to monitor

effectiveness of treatment

When To Get Tested?

Sepsis

Tumor -Alpha-fetoprotein (AFP) Test

Alpha-fetoprotein (AFP) is a protein produced primarily by the liver in a developing baby (fetus) and the portion of a developing embryo that is similar to the yolk cavity in bird eggs (yolk sac tissues). AFP

levels are typically elevated when a baby is born and then decline rapidly. Liver damage and certain cancers can increase AFP concentrations significantly. This test measures the level of AFP in the blood.

Specification

Working range 1.0-400.0 ng/mL

Reference range <15 ng/mL




Assay time 15 mins

Storage conditionCartridge: 4-30 ℃ /

Detection buffer: 2-8 ℃


Liver cancer

• To help diagnose and monitor therapy for certain cancers of the liver,

testicles, or ovaries

Why Get Tested?

• When your healthcare practitioner suspects that you have certain cancers of the

liver, testicles, or ovaries;

• At intervals during and after treatment for one of these cancers;

• When you have cancer predisposing diseases such as chronic hepatitis or

cirrhosis

When To Get Tested?

Tumor -Carcinoembryonic Antigen (CEA) Test

Carcinoembryonic antigen (CEA) is a protein that is present in certain tissues of a developing baby (fetus). By the time a baby is born, the protein drops to a very low level. In adults, CEA is normally present

at very low levels in the blood but may be elevated wit h certain types of cancer. This test measures the amount of CEA in the blood to help evaluate individuals diagnosed with cancer.

Specification






Assay time 15 mins




Colon cancer

• Primarily to monitor cancer treatment, including response to therapy and

recurrence;

• as an indicator of the amount of cancer or size of tumor present (tumor

burden) and to assist in cancer staging;

• Occasionally as follow up to a positive screening test for cancer, to

compare whether the level falls to normal (indicating that the cancer was

all likely removed) after treatment for the cancer

Why Get Tested?

• When you have been diagnosed with colon, pancreas, breast, lung, ovarian,

medullary thyroid or other cancer prior to starting cancer treatment

• If elevated, at intervals during and after therapy;

• Occasionally when cancer is suspected but not confirmed to aid in its detection

When To Get Tested?

Tumor -Prostate Specific Antigen (PSA) Test

Prostate specific antigen (PSA) is a protein produced primarily by cells in the prostate, a small gland in males that encircles the urethra and produces a fluid that makes up part of semen. Most of the PSA

that the prostate produces is released into this fluid, but small amounts of it are also released into the blood. PSA exists in two main forms in the blood: complexed (cPSA, bound to other proteins) and free

(fPSA, not bound). The most frequently used PSA test is the total PSA, which measures the sum of cPSA and fPSA in the blood.

Specification






Assay time 15 mins




• To screen for prostate cancer;

• To help determine the necessity for a biopsy of the prostate;

• To monitor the effectiveness of treatment for prostate cancer,

• To detect recurrence of prostate cancer

Why Get Tested?

• When you have symptoms suggestive of prostate cancer such as difficult, painful,

and/or frequent urination;

• May also be ordered during and at regular intervals after prostate cancer treatment;

• In asymptomatic men, after a discussion with your healthcare practitioner about the

benefits and harms of screening

When To Get Tested?

Prostate Cancer

Tumor -Fecal Occult Blood (i-FOB) Test

FOB is designed to evaluate stool samples for hidden ("occult") blood, meaning blood that cannot be seen with the naked eye. Although there are several possible causes of blood in the stool, one important

cause is the presence of polyps or cancers in the digestive tract.

• To screen for digestive tract bleeding, which may be an indicator of colon

cancer

Why Get Tested?

• The American Cancer Society recommends screening for colon cancer between

the ages of 45 and 75

• The U.S. Multi Society Task Force (MSTF) on Colorectal Cancer and the U.S.

Preventive Services Task Force (USPSTF) recommend screening starting at age

50.

• Screening annually is usually recommended if an occult blood test is used.

• When there is a suspicion that you have gastrointestinal bleeding

When To Get Tested?

Colon cancer

Specification

Working range TBD

Reference range TBD

Sample type Feces

Sample volume TBD

Loading volume TBD

Assay time TBD




Thyroid hormone -Thyroid-stimulating Hormone (TSH) Test

Thyroid stimulating hormone (TSH) is produced by the anterior pituitary gland, a small organ located below the brain and behind

the sinus cavities. TSH stimulates the thyroid, a small butterfly shaped gland located inside the neck in front of the windpipe, by

binding to the TSH receptor to release the hormones thyroxine (T4) and triiodothyronine (T3) into the blood. This test measures

the amount of TSH in the blood.

• To help diagnose thyroid disorders and to monitor treatment of

hypothyroidism and hyperthyroidism;

• To screen newborns for congenital hypothyroidism

Why Get Tested?

• When you have signs and symptoms of hyperthyroidism or hypothyroidism

and/or an enlarged thyroid (goiter)

• When you have a thyroid nodule (a small lump on the thyroid gland that may be

solid or a fluid filled cyst);

• When you are being treated for a thyroid disorder

When To Get Tested?

Specification

Working range TBD

Reference range TBD

Sample type Feces

Sample volume TBD

Loading volume TBD

Assay time TBD




Hyperthyroidism /

Hypothyroidism

Thyroid hormone -T3 (Free and Total) Test

Triiodothyronine (aT3) is one of two major hormones produced by the thyroid gland, a small butterfly-shaped organ that lies flat across the windpipe at the base of the throat. The other major

thyroid hormone is called thyroxine (T4) and together they help control the rate at which the body uses energy. Almost all of the T3 (and T4) found in the blood is bound to protein. The rest is free

(unbound) and is the biologically active form of the hormone. Tests can measure the amount of free T3 or the total T3 (bound plus unbound) in the blood.

• To help evaluate thyroid gland function;

• To diagnose thyroid disease, including hyperthyroidism, and

determine the cause;

• To monitor effectiveness of treatment of a thyroid disorder

Why Get Tested?

• When you have an abnormal thyroid stimulating hormone

(TSH), particularly with a normal free thyroxine (T4) result,

and/or signs and symptoms of hyperthyroidism

When To Get Tested?

Free T3 Specification Total T3

0.10-6.00 ng/mL Working range 1.0-20.0 pg/mL

0.8-2.0 ng/mL Reference range 2.0-4.25 pg/mL

Serum / Plasma Sample type Serum / Plasma

100 μL Sample volume 200 μL

100 μL Loading volume 100 μL

15 mins Assay time 15 mins

Cartridge: 4-30 ℃ /Detection buffer: 2-8 ℃



24 months Shelf life 24 months

Thyroid

Thyroid hormone -T4 (Free and Total) Test

Thyroxine (T4) is one of two major hormones produced by the thyroid gland, a small butterfly-shaped organ that lies flat across the windpipe at the base of the throat. The other major thyroid

hormone is called triiodothyronine (T3) and together they help control the rate at which the body uses energy. Almost all of the T4 (and T3) found in the blood is bound to protein. The rest is free

(unbound) and is the biologically active form of the hormone. This test measures the amount of free T4 in the blood.

• To help evaluate thyroid gland function;

• To help diagnose thyroid disease;

• To monitor effectiveness of thyroid treatment;

• To help diagnose congenital hypothyroidism in newborns

Why Get Tested?

• When you have signs and symptoms of thyroid disease

and/or an enlarged thyroid (goiter)

• When you have a thyroid nodule (a small lump on the

thyroid gland that may be solid or fluid filled cyst), usually

after an abnormal result on a TSH test;

• When you are being treated for a thyroid disorder

When To Get Tested?

Free T4 Specification Total T4

0.50-25.00 ug/dL Working range 0.10-8.00 ng/dL

5.9-13.8 ug/dL Reference range 0.8-1.9 ng/dL

Serum / Plasma Sample type Serum / Plasma

100 μL Sample volume 100 μL

100 μL Loading volume 100 μL

15 mins Assay time 15 mins

Cartridge: 4-30 ℃ /Detection buffer: 2-8 ℃



24 months Shelf life 24 months

Thyroid

Fertility hormone -

• To confirm a pregnancy ;

• To help identify an ectopic pregnancy;

• To monitor a pregnancy that may be at risk of failing; Occasionally to screen a

woman for pregnancy prior to some medical treatments;

• As part of a panel of tests used to screen for fetal abnormalities

Why Get Tested?

• When you suspect that you are pregnant (testing can be done reliably by 10

days after you miss your menstrual period and some methods can detect hCG

even earlier);

• When you have signs and symptoms that suggest you may have an ectopic

pregnancy or a pregnancy that is failing

When To Get Tested?

Pregnancy

Specification

Working range 1.0-30,000.0 mIU/mL

Reference range

*Male: <1.0*Female

- Non-pregnant: <5.0- Borderline: 5.0-10.0

- Pregnant: >10.0




Assay time 15 mins




Human chorionic gonadotropin (hCG) is a hormone produced by the placenta of a pregnant woman. Early in pregnancy, the level of hCG increases in the blood and is eliminated in the urine. A pregnancy

test detects hCG in the blood or urine and confirms or rules out pregnancy.

* Optibio is developing this marker as better beta-hCG test than normal hCG test

Pregnancy Test (hCG) Test

Fertility hormone -

• To evaluate fertility issues, the health of your reproductive organs (ovaries or

testicles), or pituitary function

• To evaluate early or delayed puberty for children

Why Get Tested?

• For women, when you are having difficulty getting pregnant or are having

irregular or no menstrual periods.

• For men, when your partner cannot get pregnant, or you have a low sperm

count, low muscle mass or decreased sex drive.

• When your healthcare practitioner thinks that you have symptoms of a pituitary

disorder or hypothalamic disorder.

• When a healthcare practitioner suspects that a child has delayed or earlier than

expected puberty.

When To Get Tested?

Fertility

Specification

Working range 1.0-100.0 mIU/mL

Reference range

*Girls- 0~12 years: 0.4-12.7- 12~18 yeasr: 0.3-9.0

*Females- Follicular phase: 1.8-9.4

- Ovulatory phase: 3.4-33.1- Luteal phase: 1.2-13.4

- Postmenopausal: 27.7-93.3*Boys

- 0~12 years: 0.1-2.3- 12~18 years: 1.3-8.1




Assay time 15 mins




Follicle-stimulating Hormone (FSH) Test

Follicle-stimulating hormone (FSH) is a hormone associated with reproduction and the development of eggs in women and sperm in

men. This test measures FSH in the blood.

Fertility hormone -

• To evaluate fertility issues or the health of your reproductive organs

(ovaries or testicles);

• To determine whether you have ovulated (released an egg from the ovary)

for women;

• To evaluate pituitary function

• To evaluate early or delayed puberty for children

Why Get Tested?

• When you are having difficulty getting pregnant or are having irregular or heavy

menstrual periods;

• When you are tracking ovulation during your menstrual cycle

• For men, when your partner cannot get pregnant or you have a low sperm

count, low muscle mass or decreased sex drive

• When your healthcare provider thinks that you have symptoms of a pituitary

disorder or hypothalamic disorder.

• When a healthcare practitioner suspects that a child has delayed or earlier than

expected puberty.

When To Get Tested?

Fertility

Specification

Working range 1.0-100.0 mIU/mL

Reference range

* Prepuberty: 0.1-8.9* Male: 1.0-5.3

* Females- Follicular phase: 0.8-10.4- Ovulatory phase: 2.9-41.1

- Luteal phase: 0.5-7.6- Postmenopausal: 14.4-52.8




Assay time 15 mins




Luteinizing Hormone (LH) Test

Luteinizing hormone (LH) is a hormone associated with reproduction. Its stimulation of either ovary or testicles results in the release

of an egg from the ovary (ovulation) in women or testosterone production in men. This test measures the amount of luteinizing

hormone in the blood.

Cortisol Test

Cortisol is a hormone that plays a role in the metabolism of proteins, lipids, and carbohydrates. It affects blood glucose levels, helps maintain blood pressure, and helps regulate the immune system.

Most cortisol in the blood is bound to a protein; only a small percentage is "free" and biologically active. Free cortisol is secreted into the urine and is present in the saliva. This test measures the

amount of cortisol in the blood, urine, or saliva.

Fertility hormone -

Specification

Working range 1.0-25.0 ug/dL

Reference range* Morning: 5-25

* Afternoon: 2.5-12.5




Assay time 15 mins




• To help diagnose Cushing syndrome or primary or secondary adrenal

insufficiency (Addison disease);

• To detect conditions affecting the pituitary or adrenal glands

Why Get Tested?

• When your healthcare provider suspects excess or deficient cortisol production

When To Get Tested?

Prolactin Test

Prolactin is a hormone whose primary role is to promote breast milk production (lactation). It is normally elevated in women during pregnancy and just after childbirth. It is normally low in men and

non-pregnant women. This test measures the amount of prolactin in the blood.

Fertility hormone -

Specification


Reference range* Female: <25

* Male: <20




Assay time 15 mins




Galactorrhea

• To help investigate unexplained flow of breast milk (galactorrhea), abnormal

nipple discharge, absence of menstrual periods, and/or infertility in women;

• To help diagnose the cause of decreased libido and/or erectile dysfunction in

men;

• To detect and monitor a pituitary tumor that produces

• prolactin (prolactinoma)

Why Get Tested?

• When you have symptoms of elevated prolactin, such as vision problems and

headaches;

• During a workup for infertility;

• For follow up of macroprolactin;

• When a man has low testosterone;

• Periodically to monitor for recurrence of a pituitary tumor

When To Get Tested?

Progesterone Test

Progesterone is a steroid hormone whose main role is to help prepare a woman's body for pregnancy. It works in conjunction

with several other female hormones. This test measures the level of progesterone in the blood.

Fertility hormone -

Specification


Reference range

Male: 0.3-1.0 ng/mLFemale-follicular phase : <0.3-1.8

ng/mL-lusteal phase : 6.4-35 ng/mL

-Pregnant1/3Q : 9.1-29.4,

2/3Q : 21.7-76.5, 3/3Q : 81-274 ng/mL

-taking oral contraceptives : <0.3 ng/mL




Assay time 15 mins


buffer: 2-8 ℃


Fertility

• To help determine the cause of infertility and track ovulation;

• To help diagnose an ectopic or failing pregnance; monitor the health of a

pregnancy;

• To monitor progesterone replacement therapy;

• To help diagnose the cause of abnormal uterine bleeding

Why Get Tested?

• At specific times during a woman's menstrual cycle to determine whether/when

she is ovulating (releasing an egg from an ovary);

• During early pregnancy when symptoms suggest an ectopic or failing pregnancy;

• Throughout a high risk pregnancy to help determine placenta and fetal health;

• Periodically when a person is receiving progesterone replacement therapy;

• When a woman has abnormal uterine bleeding

When To Get Tested?

Fertility hormone -

Testosterone is the main sex hormone (androgen) in men. It is responsible for male physical characteristics. Although it is considered to be a "male" sex hormone, it is present in the blood of

both men and women. This test measures the level of testosterone in the blood.

Testosterone Test

Specification


Reference range* Female: 0-0.80* Male: 2.6-15.9




Assay time 15 mins




• To detect an abnormal testosterone level in males and females; To help

diagnose the cause of erectile dysfunction or the inability of your partner

to get pregnant (infertility);

• To help diagnose the cause of masculine physical features (virilization),

infertility, or polycystic ovary syndrome (PCOS);

• To help determine the cause of genitals that are not clearly male or

female (ambiguous genitalia) or delayed or early puberty in children

Why Get Tested?

• For males, when you may be

infertile or are unable to get or

maintain an erection;

• When you are a boy with either

early or delayed sexual maturity

(puberty)

• For females, when you have male

traits, such as a low voice or

excessive body hair (hirsutism),

• When you have abnormal uterine

bleeding, do not menstruate

(amenorrhea), or are infertile

When To Get Tested?

fertility

- TnI

Heart attack

Specification


Reference range 0.04 ng/mL




Assay time 15 mins




• To help detect, diagnose, and in some cases evaluate the

severity of heart disease, including congestive heart

failure (CHF)

Why Get Tested?

• Immediately, then followed by a series of troponin tests

over several hours when you are having signs and

symptoms that may be due to a heart attack, such as pain

in your chest, shoulders, neck, jaw and/or shortness of

breath;

• When your angina worsens, especially if it does not

resolve with rest

When To Get Tested?

Troponins are a group of proteins found in skeletal and heart (cardiac) muscle fibers that regulate muscular contraction. Troponin tests measure the level of cardiac-specific troponin in the blood to help

detect heart injury.

There are three types of troponin proteins: troponin C, troponin T, and troponin I. Troponin C initiates contraction by binding calcium and moves troponin I so that the two proteins that pull the muscle fiber

shorter can interact. Troponin T anchors the troponin complex to the muscle fiber structure. There is little or no difference in troponin C between skeletal and cardiac muscle, but the forms of troponin I and

troponin T are different. Measuring the amount of cardiac-specific troponin T or troponin I in the blood can help identify individuals who have experienced damage to their heart.

Troponin I (TnI) Test

- Myoglobin

Myoglobin is a small protein found in heart and skeletal muscles that binds oxygen. It traps oxygen within muscle cells, allowing the cells to produce the energy required for muscles to contract.

When heart or skeletal muscle is injured, myoglobin is released into the blood. Elevated levels can be measured within a few hours following an injury.

Myoglobin Test

Muscle damage

Specification


Reference range ≤70 ng/mL




Assay time 15 mins




• To determine whether muscle has been

injured;

• To help diagnose conditions associated with

muscle damage;

• To detect high levels in the urine that can

cause kidney damage after extensive muscle

damage;

• Sometimes to help determine if you have had

a heart attack

Why Get Tested?

• When you have muscle weakness, muscle

aches, and/or dark urine and your healthcare

provider suspects muscle damage;

• When there has been severe traumatic injury

to skeletal muscle

When To Get Tested?

- CK-MB

Creatine kinase-MB (CK-MB) is a form of an enzyme found primarily in heart muscle cells. This test measures CK-MB in the blood.

CK-MB is one of three forms (isoenzymes) of the enzyme creatine kinase (CK). These isoenzymes include:

CK-MM (found in skeletal muscles and the heart)

CK-MB (found mostly in the heart, but small amounts found in skeletal muscles)

CK-BB (found mostly in the brain and smooth muscle, such as the intestines and uterus)

CK-MB Test

Specification


Reference range ≤5 ng/mL




Assay time 15 mins




• To distinguish between skeletal

muscle and heart muscle

damage;

• To determine if you have had a

heart attack (if the troponin

test is not available);

• To detect a second or

subsequent heart attack or to

monitor for additional heart

damage

Why Get Tested?

• When you have an increased

creatine kinase (CK) level and the

healthcare practitioner wants to

determine whether it is due to

skeletal or heart muscle damage;

• When it is suspected that you

have had a second heart attack or

have ongoing heart damage

When To Get Tested?Muscle damage

- D-Dimer

D-dimer is one of the protein fragments produced when a blood clot gets dissolved in the body. It is normally undetectable or detectable at a very low level unless the body is forming and

breaking down blood clots. Then, its level in the blood can significantly rise. This test detects D-dimer in the blood.

D-Dimer Test

Thrombotic

Specification

Working range 4~15%

Reference range < 6.5%.

Sample type Whole blood

Sample volume 100 ul

Loading volume 100 ul

Assay time 3 mins




• To help rule out clotting (thrombotic)

• To help diagnose conditions related to

thrombosis

Why Get Tested?

• When you have symptoms of a blood clot or a

condition that causes inappropriate blood

clots, such as deep vein thrombosis (DVT),

pulmonary embolism (PE), or disseminated

intravascular coagulation (DIC);

• To monitor treatment of DIC and excessive

clotting conditions

When To Get Tested?

- NT-proBNP

Congestive heart failure

Specification

Working range 1-30,000 pg/mL





Assay time 15 mins




• To help detect, diagnose, and in some cases evaluate the

severity of heart disease, including congestive heart

failure (CHF)

Why Get Tested?

• When you have symptoms such as shortness of breath,

fatigue, excessive fluid in your abdomen, and swollen

ankles and legs after a heart attack or during treatment

for heart disease

When To Get Tested?

B-type natriuretic peptide (BNP) and N-terminal pro b-type natriuretic peptide (NTproBNP) are peptide (small proteins) that are either hormones or part of the peptide that contained the hormone at one

time. They are continually produced in small quantities in the heart and released in larger quantities when the heart senses that it needs to work harder. This supports fluid retention and volume expansion in

the arteries and veins. Subsequently, the heart muscle is stretched and works hard to pump blood under normal resting condition. Tests for BNP and NT-proBNP measure their levels in the blood in order to

detect and evaluate heart failure. The two tests are not interchangeable and should not be used together. Your healthcare practitioner should order one or the other but not both.

NT-proBNP Test

Diabetes

- HbA1c

• To help determine

whether you are at an

increased risk of

developing diabetes;

• To help diagnose

diabetes and

prediabetes; to monitor

diabetes and to aid in

treatment decisions

Why Get Tested?

• As part of a health checkup or

when you have risk factors for or

symptoms of diabetes;

• After first diagnosis with diabetes,

every 3~4 months or about 120

days to ensure that your glycemic

goals are met and/or maintained

or when your therapy plan has

changed

When To Get Tested?Specification

Working range 4~15%

Reference range < 6.5%.

Sample type Whole blood

Sample volume 100 ul

Loading volume 100 ul

Assay time 3 mins




Hemoglobin A1c, also called A1c or glycated hemoglobin, is hemoglobin with glucose attached. The A1c test evaluates the average

amount of glucose in the blood over the last 2 to 3 months by measuring the percentage of glycated hemoglobin in the blood.

Hemoglobin A1c (HbA1c) Test

Ferritin

Anemia

Specification

Working range 1.0-1,000.0 ng/mL

Reference range* Female: 10-200

* Male: 30-300




Assay time 15 mins




• To determine your body's total iron storage

capacity;

• • To help diagnose iron deficiency or iron

overload

Why Get Tested?

• When you have low hemoglobin and

hematocrit on a complete blood count (CBC);

• When your healthcare practitioner suspects

that you may have too little iron (iron

deficiency) or too much iron (iron overload) in

the body

When To Get Tested?

Ferritin is a protein that contains iron and is the primary form of iron stored inside of cells. The small amount of ferritin that is released and circulates in the blood is a reflection of the total

amount of iron stored in the body. This test measures the amount of ferritin in the blood.

Ferritin Test

Vitamin D deficiency

Vitamin D

• To determine if you

have a vitamin D

deficiency;

• If you are receiving

vitamin D

supplementation, to

determine if it is

adequate

Why Get Tested?

• When you have an abnormal calcium,

phosphorus, and/or parathyroid hormone

level;

• When you have evidence of bone disease or

bone weakness;

• When you are at high risk of deficiency or a

healthcare practitioner suspects that you

might have a vitamin D deficiency;

• Prior to starting drug treatment for

osteoporosis;

• To periodically monitor treatment of vitamin

D deficiency

When To Get Tested?

Specification


Reference range* Deficiency : 10 ng/mL* Insufficiency : 10-29

ng/mL




Assay time 15 mins




Vitamin D is a family of compounds that is essential for the proper growth and formation of teeth and bones. This test measures

the level of vitamin D in the blood.

Two forms of vitamin D can be measured in the blood, 25-hydroxyvitamin D and 1,25-dihydroxyvitamin D. The 25-hydroxyvitamin D

is the major form found in the blood and is the relatively inactive precursor to the active hormone, 1,25-dihydroxyvitamin D.

Because of its long half-life and higher concentration, 25-hydroxyvitamin D is commonly measured to assess and monitor vitamin D

status in individuals.

Vitamin D Test

Market & Business

Instrument development

service

Comparison of other Company(Country)

OptiBio(Korea)

Precision Biosensor(Korea)

K-MAC(Korea)

Labsim(China)

Qiagen(Germany)

Brand(Photo)

Optical Q Exdia TRF Plus Easy Check AFS-1000 ESEQuant LR3

OS C language(Non-OS) Android Android Linux Android

Display 5" Non-Touch Screen 7" Touch Screen 7" Touch Screen 7" Touch Screen 7" Touch Screen

Power supply Battery unavailable Battery available Battery unavailable Battery unavailable Battery available

Dimensions(L x W x H)

357 x 284 x 156 mm 210 x 275 x 182 mm 218 X 263 X 277 mm 280 x 220 x 150 mm 236 x 215 x 104 mm

Weight 1.5 kg 1.6 kg 2.7 kg 2.5 kg 2.5 kg

Light source/ Detector

Laser / PD LED / CCD LED / CCD LED / PD LED / PD

Sensor filter Alexa 647: 650/680 nm Europium: 320/600 nmEuropium:

Around 300~600 nm

Fluorescein(FITC):470/525 nm, 365/615 nm585/610 nm, 635/680 nm

Fluorescein: 470/520 nmEuropium: 360/625 nm

DyLight: 625/680 nm

Analysis method Scan Capture(TRF available) Capture(TRF available) Scan Scan

User interfaceRS422/USB

Mini 5pin/RFID/BarcodeRS232/USB

LAN/BarcodeLAN/USB

QR Code/BarcodeRS232/USB

LAN/QR Code/BarcodeUSB/RFIDBarcode

• Other company’s analyzer can also change the kit inlet holder and the fluorescence filter wavelength band, but there are not many cases of universal application.

• Reason: There is a limit to the structural change of the optical part, which is the core of the kit analysis.

POCT Modular System

AnalysisMethod

Analyte Wavelength band Light source Detector

Scanmethod

(Quantitative)

Alexa 647 650/680 nm Laser PD

FSD 488 495/519 nm LED PD

Quantum Dot 405/620 nm LED PD

Capturemethod

(Qualitative)

Europium 360/625 nm LED CMOS

Colloidal Gold Visible Wavelength LED CMOS

Colerd latex beads Visible Wavelength LED CMOS

OptiBio plans to maximize the

versatility of the analyzer by

providing an optical module that is

completely optimized optically

according to the analysis method

and analyte, rather than simply

changing the optical part like most

analyzers in the market.

Embedded SW (Incl. GUI)

Exterior case mold design

Kit intlet (Holder)

Optical module

Mutable elements

Overall analyzer size

Electronic board and Firmware

Power input method

For analyzer operation and analysis

PC software

Immutable elements

Touch screen

Internal printer

LIS port (RS232, LAN)

QR Code, RFID etc.

Optional elements (Accessory)

POCT Modular System

Mass-production

analyzer

Universalanalyzer

Customizedanalyzer

Design applied to mass production and

overall resized model

Models with only optical

modules and accessories

changed in existing systems

If necessary, models with the exterior case and

embedded software are changed & the final fine

optical is corrected

POCTModular System

Phase 1

At OptiBio, we provide and sell general-

purpose analyzer, so that customers can

evaluate and test their own kits. It is

necessary to set the unit price considering

the characteristics of each region

Internal evaluation of samples with

large-scale optical analysis equipment

for experiments

Provides optical module series with

high versatility (Expected to provide

80~90% of kit analysis ability)

Provides PC software for operation and

analysis that can be applied to various

analysis algorithms

Supplying universal analyzer

Phase 2

For customers who have completed

development of their prototype using our

general-purpose analyzer, we also provide

customized and tailored development

services at extra cost as follows:.

Fine adjustment of general-purpose

optical module such as filter change

(Purpose of providing 100% of kit

analysis ability)

Customized exterior case production

Embedded software production

Customizing analyzer specifications

Phase 3

For customers who have completed

performance verification and first

development with prototype analyzer and

kits, we can provide final design changes

and customized services in line with mass

production

Mass production and delivery services

(Need to set delivery price and

minimum purchase quantity)

Mass production technology transfer

available through technology

transfer fee (Differentiation of

technology transfer fee according to

period and place)

Supplying mass production

anlyzer

OptiBio POCT Modular System Ordering Website Modular System Customizing Page

360°

* The product image is for illustrative purposes only and may differ

from the actual product

Optical module Exterior Interior

Detailed specification selected by the user

Accessory

Touch Screen USB

RFIDBarcode

LAN

Printer

Analyte

Alexa 647 : 650/665nm

Quantum Dot

Europium : 360/625nm

Colloidal Gold

Colerd latex beads

FSD 488 : 495/519nm

Quantitative (Scan type)

Qualitative(Capture type)

0.3ng/mL

Thank youThe Global Leader of Optic Technology & N.B.IT Convergence Technology

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