Welcome to YD Diagnostics

- Feature

Convenient to use for both of visual and analyzer

- Long handling part and easy bending for small sample volume

Satisfy user’s needs with 14 different items

- Well designed test position from Blood to Ascorbic acid

Accuracy, precision, reproducibility and stability

- With more than 40 years experience proved by worldwide customers over 116 countries

Ascorbic acid warning system

- Free from false report caused by Ascorbic acid

- Ascorbic acid pad indicate concentration of Vitamin-C in urine

Compensate urine color with Compensation area

- Unusual color of urine can be reported and compensated

CE marked and FDA approved for professional use and self-test

- Product line

Item
No.

Test Portion

Blood

Bilirubin

Urobilinogen

Ketones

Protein

Nitrite

Glucose

S.G

Leucocytes

Ascorbic
acid

Product name

Package size
(tests)

U11

1 Protein strip

50/100

■

* U12

4 HemoGPH strip

100

■

U15

1 Ketones strip

50/100

■

U19

1 Glucose strip

50/100

■

U20

2 GP strip

100

■

U21

3 GPH strip

100

■

* U22

5 HemoketoGPH strip

100

■

U24

2 Gluketo strip

50/100

■

* U25

6 L strip

100

■

* U26

8 strip

100

■

* U27

7 strip

100

■

* U37

9 SG strip

100

■

* U39

10 SGL strip

100

■

* U41

11 strip

100

■

* U81

URiSCAN SUPER Cassette

400

■

URiSCAN Strip

FEATURES

ㆍ CE marked, FDA 510(K) approved and CLIA-Waived for professional use and self-test

ㆍ Four Configurations of Urine Strips : URiSCAN 2ACR, URiSCAN 10ACR, URiSCAN 11ACR strip and URiSCAN 13ACR Cassette

ㆍ Calculates Microalbumin to Creatinine Ratio

ㆍ Read with upgraded URiSCAN Optima, PRO and Super+ Urine Analyzer

URiSCAN Analyzers

Test parameter		Print & Display Result
Test parameter		Conventional unit	S.I. unit
Microalbumin	ALB	10 mg/L (-) 30 mg/L (+) 80 mg/L (++) 150 mg/L (+++)	10 mg/L (-) 30 mg/L (+) 80 mg/L (++) 150 mg/L (+++)
Creatinine	CRE	10 mg/dL (±) 50 mg/dL (+) 100 mg/dL (++) 200 mg/dL (+++) 300 mg/dL (++++)	0.9 mmol/L (±) 4.4 mmol/L (+) 8.8 mmol/L (++) 17.7 mmol/L (+++) 26.5 mmol/L (++++)
Microalbumin/Creatinine	ACR	< 30 mg/g 30-300 mg/g >300 mg/g	< 3.4 mg/mmol 3.4-33.9 mg/mmol >33.9 mg/mmol

Product Line

Item
No.

Test Portion

Vt.C

LEU

GLU

ALB

NIT

PRO

KET

URO

CRE

S.G

BIL

BLD

Product name

Package

U62

10 ACR strip

100

U63

11 ACR strip

100

U64

2 ACR strip

25/50

U80

13 ACR Cassette

400

Vt.C : Ascorbic Acid
LEU : Leucocytes
GLU : Glucose

ALB : Microalbumin
NIT : Nitrite
PRO : Protein
KET : Ketones

URO : Urobilinogen
CRE : Creatinine
BIL : Bilirubin
BLD : Blood

URiSCAN ACR Strip

Easy access to review test results
(printout data selectable)

Interface for the external barcode reader,
PC and lab network system
Easy connect by 2 USB port

Reflection photometer :CCD color image sensor (image capture) and 3 LED for light source
Color and clarity reading available

1.3" Touch Screen TFT LCD
Sofrware available in English, German, Spanish, Italian, Ploish, Chinese and Russian

Memory capacity:
2,000 test results
Simple calibration
Easy data management & various
data printing format
Workable with 4-11 parameter strips

- Technical Specifications

Operation mode	Semi-automatic urine analyzer
Materials	ABS Resin
Dimension	200mm(M) × 240mm(D) × 90mm(H)
Weight	970g
Rated voltage	100 ~ 240V
Rated frequency	50/60Hz
Rated power	42VA
Operating conditions	Temperature : 10℃ ~ 40℃(50℉ ~ 104℉) Humidity : 10%~70%
Storage conditions	Temperature : 0℃~40℃(32℉ ~ 104℉) Humidity : 10%~85%
Measurement method type	Reflectance photometers

Measurement Cycle	Routine mode : 100 seconds Quick mode : 6 seconds
Memory capacity	2000 Patient data
Sensor	CCD color image sensor
Light Source	LED
Result Display	4.3" TFT LCD
Printer	High speed thermal printer 203 dpi (8dots/mm)
Host-communication	Bi directional RS 232C interface for data transfer to HOST
Peripherals	Barcode reader, External printer
Safety stadard	EN / IEC 61010-1
EMC standard	Emission EN55011/A1 : 1997,A2:1996, Group 1, Class A immunity EN 61000-4-/3/4/5/6//11
Approval	CE, FDA

URiSCAN Optima

ㆍPossible to connet to the PC or to the lab network system
ㆍOptional hand-held barcode scanner can be connected
ㆍExternal printer interface : pararell port connector

ㆍOnboard thermal printer for easy access to review test results

ㆍAC/DC Adaptor : AC 100V-240V, 50/60Hz
ㆍURiSCAN PRO : DC 12V, 3.5A

ㆍ7″ Touch Screen TFT LCD
ㆍSoftware available in English, German, Spanish, Italian, Portuguess, Chinese, Russian and Korean

ㆍMemory capacity : 3,000 patient records,
1,000 control data and 30 calibration data
ㆍSimple calibration
ㆍEasy data management & various data printing format

ㆍHighest throughput : 720 tests per hour
ㆍClosed system : Allow to read only URiSCAN branded urine test strips
ㆍAutomatic adjustment for urine color
ㆍManual clarity input mode

Reflectance photometer :
CCD color image sensor and
LED for light source

Technical Specifications

Operation Mode	Semi-autoomation
Dimension	463mm(W) × 370mm(D) × 173mm(H)
Weight	4.7Kg
Electrical Input Rated Voltage	AC/DC Adaptor : AC 100V - 240V, Free Voltage
Rated Frequency	50/60Hz
Rated Power	42VA
Host Communication	RS 232C, USB
Operating Conditions	Temperature : 2 ~ 30 ℃(35.6 ~ 86 ℉) Humidity : 10 % ~ 70 %
Storage Conditions	Temperature : 0 ~ 40 ℃(32 ~ 104 ℉) Humidity : 10 % ~ 85 %
Test Parameter	Blood, Bilirubin, Urobilinogen, Ketones, Protein, Nitrite, Blood, Bilirubin, Urobilinogen, Ketones, Protein, Nitrite, Microalbumin, Creatinine, Color, Clarity

Measurement Method Type	Reflectance photometer
Test Capacity	720 tests per hour
Measurement cycle	5 seconds
Memory Capacity	3,000 patient records, 1,000 control data, 30 calibration data
Sensor	CCD color image sensor
Light Source	LED
Result Displayn	7″ TFT LCD(800 × 480)
Printer	High speed thermal-printer 200dpi (8dots/mm)
Peripherals	Barcode reader, External printer
EMC Standard	EN 61326-1, EN 61326-2-6
Safety Standard	EN 61010-1, EN 61010-2-101

URiSCAN Pro

Touch screen LCD
Menu driven 8.4″ large color touch LCD for convenient operation
Display the real view of the test strip image during operation

Cassette room
Double-sealed Super Strip Cassette for extended on-board stability
New Strip delivery System : Elevator system for strip loadeing

Interface
Various interfaces such ae 4 USB, RS232C, serial interface, 2 PS/2, parallel, Ethernet
Easy inegration into the lab and hospital network system

Single probe
Detect liquid level and aspirate together

Sample loading
Capable of loading up to 100 samples at once

Refractometer & Turbidimeter with CCD Image Scanner
Built in refractometer for S.G and Turbidimeter for turbidity
Accurate result by CCD Image Scanner

Syringe pump
Adoption of high performance 5ml syringe pump for precise sample treatment

Integrated barcode reader for sample ID
Apply advanced barcode reader(300 scans/sec)

Waste pump
Built-in waste pump for effective discharge of waste liquid

STAT Position
Enable to test urgent sample during normal operation

Able to test Microalbumin and Creatinine in 13 parameter Super+ strip Cassette

Test parameters : Blood,Bilirubin, Creatinene, Urobilinogen, Ketones, Protein, Nitrite, Microalbumin, Glucose, pH, Leukocytes, Ascorbic acid, Color S.G(By Refractometer), Clarity(By Turbidimeter)

Accurate and reliable performance by using proven URISCAN test striips

Load 400 tests at one time using ready-to-use Super+ Strip Cassette

Double-sealed Super Strip Cassette for extended on-board stability

Unique cassette type reagent supply system simplifies loading and operation

Continuous reagent roll offers high reliability of strip transport

Load the maximum of 400 tests at once for optimized reagent replacement time

Cassette type reagent format minimizes handling time

Easily integrates into the lab and hospital network system via Ethernet.

Using standard 10-Position rack ensures easy lab integration

Color LCD touch screen with friendly GUI makes the analyzer ease of use, quick and convenient

- Technical Specifications

Dimension	536mm(W) × 686mm(D) × 535mm(H)
Weight	70 Kg
Voltage	110~240V (50/60Hz), free voltage
Rated power	636W
Measurement Method	Test type : reflectance photometers + CCD camera image capture Throughput : 200 tests per hour Test parameters : Blood, Bilirubin, Creatinine, UroBilinogen, Ketones, Protein, Nitrite, Microalbumin, Glucose, pH, Leukocytes, Ascorbic acid, Color S.G(By Refractometer), Clarity(By Turbidimeter) Sensor : Camera+CCD color image sensor Memory capacity : more than 1,000,000 patient test results, 500 control results Light source : LED
Display	8.4” LCD touch screen
Reagent volume	400 samples at once
Sample volume	Min 1.5 ~ 2.0mL
Sample Rack	Standard 10-position rack
Sample Loading	100 samples at one time
Stat sample	Hanling 1 stat in the rack
Operating conditions	Temperature : 15 ~ 30℃ Humidity : 20 ~ 80%
Approval	CE

URiSCAN Super+

URiSCAN PluScope

Counting chamber	4
Sample loading	10 tubes/rack, 10 racks onboard, constant loading by barcode scan
Throughput	Up to 100 T/H
STAT	One STAT position and one probe clean position
Parameters	14 reportable parameters(RBC, WBC, WBCC, NEC, CRYS, AMO CRYS, YST, EC, HYA Cast, GRA Cast, SPERM, UNCC, BACT rod, BACT cocci), 1 research parameter(POI), 2 editable parameters(TRI, MUC), 30 customized parameters
Reporting format	International system of units XX/μl or XX/hpf
Network function	USB, LAN, COM, LIS
Expansion ability	Receive data from urine chemistry instrument and integrated into a urinalysis report
Dimension	600 mm(W) × 525 mm(D) × 740 mm(H)

Urinalysis Control

Product name		Item No.	Package
URiTROL Liquid	Uritrol Liquid Level 1	U5-11	15 ml × 3
	Uritrol Liquid Level 2	U5-12	15 ml × 3
	Uritrol Liquid 1, 2	U5-13	15 ml × 2
URiTROL	Uritrol 1	U5-01	10 ml × 3
	Uritrol 2	U5-02	10 ml × 20
	Uritrol 3	U5-03	10 ml × 3
	Uritrol 1, 2, 3	U5-04	10 ml × 3

Intended use

URiTROL™ Liquid Urinalysis control, Dropper Style, is intended for use as an assayed quality control urine to monitor and maintain the accuracy and precision of the urine strip and the analyzers.

Stability and Storage

1) Unopened vial : it will the control is opened and stored at 2 ℃ to 8 ℃

2) Opened vial : once the control is opened and stored tightly capped, all analyses will be stable for 2 weeks at room temperature (15 ℃ to 25 ℃)

※ Please do not store the control in a refrigerator after open. If the control stored temperature is changeable as like keeping in a refrigerator and room, the stability of control will be unstable.

Features

ㆍ Liquid ready format
- Easy dispensing vial stability

ㆍ Maximum open vial stability
- 2 weeks open-vial stability at Room temperature(2 - 30 ℃)

ㆍ 24 months shelf life at 2 - 8 ℃

ㆍ High performance for most available urine test strips and strip system

- Analyte Range_URiTROL Liquid

TEST	Analyte Range
TEST	Level 1	Level 2
Blood	Negative	2+ ~ 3+ (50 ~ 250 RBC/㎕)
Bilirubin	Negative	2+ ~ 3+ (1.0 ~ 3.0 mg/dL)
Urobilinogen	Normal (±) (0.1 ~ 1.0 mg/dL)	2+ ~ 4+ (4 ~ 12 mg/dL)
Ketones	Negative	1+ ~ 3+ (10 ~ 100 mg/dL)
Protein	Negative	2+ ~ 4+ (100 ~ 1,000 mg/dL)
Nitrite	Negative	Positive
Glucose	Negative	1+ ~ 4+ (250 ~ 2,000 mg/dL)
pH	5.0 ~ 7.0	5.0 ~ 7.0
S.G	≤ 1.005 ~ 1.025	1.010 ~ ≥ 1.030
Refractomete	1.000 ~ 1.010	1.015 ~ 1.030
Leucocytes	Negative	1+ ~ 3+ (25 ~ 500 WBC/㎕)
Ascorbic Acid	1+ ~ 3+ (10 ~ 50 mg/dL)	Negative
Microalbumin	Negative - 30 mg/L (Negative ~ 1+)	80 ~ 150 mg/L (2+ ~ 3+)
Creatinine	10 ~ 100 mg/dL (± ~ 2+)	100 ~ 300 mg/dL (2+ ~ 4+)

Intended use

URiTROL™ Urinalysis control is intended to be used as an assayed quality control urine to monitor and maintain the accuracy and precision of the urine strips and the analyzers.

Stability and Storage

1) Store at 2~8°C(refrigerator).

2) Once opened, all analytes will be stable for 10days (Level I & Level III), 24hours (Level II) or 20 immersions, when stored at 2~8°C, securely sealed.

3) You can extend the expiration date of URiTROL™ for 1 month after reconstitution as follows.
   - Reconstitute URiTROL™ with 10mL of distilled water and thoroughly mix the contents of the vial by gently inverting the vial for several minutes.
   - Pipet 2mL of the reconstituted URiTROL™ into each of clean capped tubes and freeze them.
   - Defrost URiTROL™ to be same with room temperature before test by dropping method.

Features

ㆍ Lyophillzed product
- Easy transportation (Stable at least for 3 months even at room temp.)

ㆍ Maximum Open Stability

ㆍ 18 months shelf life at 2 - 8 ℃

ㆍ High performance especially for URiSCAN urine test strips and strip system

- Analyte Range_URiTROL

TEST	Analyte Range
TEST	Level 1	Level 2	Level 3
Blood	Negative	2+ ~ 3+ (50 ~ 250 RBC/㎕)
Bilirubin	Negative	Negative	2+ ~ 3+ (1.0 ~ 3.0 mg/dL)
Urobilinogen	Normal (0.1 ~ 1.0 mg/dL)	Normal (0.1 ~ 1.0 mg/dL)
Ketones	Negative	1+ ~ 3+ (10 ~ 100 mg/dL)
Protein	Negative	Negative	2+ ~ 4+ (100 ~ 1,000 mg/dL)
Nitrite	Negative	Positive
Glucose	Negative	2+ ~ 4+ (500 ~ 2,000 mg/dL)
pH	5.0 ~ 7.0	6.0 ~ 8.0
S.G (URiSCAN PRO & Optima sereise)	1.015 ~ ≥ 1.030	≤ 1.005 ~ 1.015
Leucocytes	Negative	2+ ~ 3+ (75 ~ 500 WBC/㎕)
Ascorbic Acid	1+ ~ 3+ (10 ~ 50 mg/dL)	Negative
Micro Albumin	Neg. ~ 1+ (Neg ~ 30 mg/L)	Neg. ~ 1+ (Neg ~ 30 mg/L)	2+ ~ 3+ (80 ~ 150 mg/L)
Creatinine	± (10 mg/dL)	± ~ 1+ (10 ~ 50 mg/dL)	1+ ~ 3+ (50 ~ 200 mg/dL)
S.G / Refractometer method (URiSCAN Super)	1.000 ~ 1.010	1.005 ~ 1.015

URiTROL

Product name		Cat No.	Information	Unit
- Polymerase Chain Reaction(PCR)
	MolecuTech TB-Tag Two^®	M012	Two-tube Nested PCR-based Assay System for Detection of only MTB among MTB complex	50 T/kit
	MolecuTech MTB-ID V3^®	M024	PCR-based Assay System for Simultaneous Detection of MTB and Other Mycobacteria	100 T/kit
- Real time PCR
	MolecuTech Real TB-Tag^®	M034	Real-time PCR-based Assay System for Detection of only MTB among MTB complex	100 T/kit
	MolecuTech Real MTB-ID^®	M144	Real-time PCR-based Assay System for Simultaneous Detection of MTB and Other Mycobacteria	100 T/kit
- Reverse Blot Hybridization Assay(REBA)
	MolecuTech REBA Myco-ID^®	M067	Reverse Blot Hybridization Assay System for Identification of Mycobacterial Species Including MTB	48 T/kit
	MolecuTech REBA MTB-MDR^®	M119	Reverse Blot Hybridization Assay System for Determination of Rifampin and Isoniazid Susceptibility of MTB	24 T/kit
	MolecuTech REBA MTB-XDR^®	M129	Reverse Blot Hybridization Assay System for Determination of Fluoroquinolone, Kanamycin and Streptomycin Susceptibility of MTB	24 T/kit

- Technical Specification

Features

Rapid and accurate detection only MTB among MTB complex

Specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen

High specificity and sensitivity with two-tube nested PCR

All in one system : from DNA extraction to agarose gel electrophoresis of PCR product

Internal control is included, determining existence of PCR inhibitor within specimens

Sensitivity and Specificity

Sensitivity : detect up to 2 ~20 bacilli

Specificity : detect specific target region for only MTB

Data Interpretation

Features

Rapid and accurate detection and differentiates MTB and NTM at DNA level simultaneously

Specimen : DNA of culture isolate

High specificity and sensitivity by application multiplex and one-tube nested PCR

All in one system : from DNA extraction to agarose gel electrophoresis of PCR product

Internal control is included, determining existence of PCR inhibitor within specimens

Sensitivity and Specificity

Sensitivity for MTB : detect up to 2~20 bacilli

Sensitivity for NTM : detect up to 200 bacilli

Specificity : no cross-reactivity between MTB and NTM

Data Interpretation

Features

Rapid and accurate detection

Specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen

High specificity and sensitivity

Simple procedure and closed system
- Not required gel electrophoresis
- Minimized to cross or carry-over contamination in process

DNA extraction solution included

Sensitivity and Specificity

Sensitivity : detect up to 2 ~20 bacilli

Specificity : detect specific target region for only MTB

Data Interpretation

Features

Rapid and accurate detection

Diverse clinical specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen

High specificity and sensitivity

Simple procedure and closed system
- Not required gel electrophoresis
- Minimized to cross or carry-over contamination in process

DNA extraction solution included

Sensitivity and Specificity

Sensitivity for MTB : detect up to 2~20 bacilli

Sensitivity for NTM : detect up to 200 bacilli

Specificity : no cross-reactivity between MTB and NTM

Data Interpretation

Features

Identification of 19 species of NTM

Diverse clinical specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen

High sensitivity and specificity by binding to species specific probe

Rapid test within 2 hours after PCR reaction

Useful for mixed or multiple infection of mycobacteria

Sensitivity and Specificity

Sensitivity for NTM : detect up to 20 bacilli

Specificity : identify MTB and 19 species of NTM (detect to over 100 species NTM)

Data Interpretation

Features

Rapid and accurate detection of rifampin and isoniazid resistance of MTB

Diverse clinical specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen (not required culture)

High sensitivity and specificity by binding to target gene specific probe
- Rifampin target : rpoB
- Isoniazid target : katG, inhA, and ahpC intergenic region

Rapid test within 2 hours after PCR reaction

Sensitivity and Specificity

Sensitivity : detect up to 20 bacilli

Specificity : detect drug susceptibility for rifampin and isoniazid of MTB

Data Interpretation

Features

Rapid and accurate detection extensively drug-resistance (XDR) of MTB

Diverse clinical specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen (not required culture)

High sensitivity and specificity by binding to target gene specific probe

Rapid test within 2 hours after PCR reaction

Sensitivity and Specificity

Sensitivity for NTM : detect up to 20 bacilli

Specificity : detect drug susceptibility for kanamycin, fluoroquinolone and streptomycin of MTB

Data Interpretation

PCR-based Assay for TB

Product name		Cat No.	Information	Unit
- Human Papillomavirus
	REBA HPV-ID^®	M137 M138	Reverse Blot Hybridization Assay System for Identification of Human Papilloma Virus (HPV) Genotypes	48 T/kit 96 T/kit
	Real HPV 16/18/HR^®	M132	Real-time PCR-based Assay System for Detection of HPV 16/18/HR	50 T/kit
- Product line of Sexually Transmitted infection
	Real CT/NG^®	M162	Real-time PCR-based Assay System for Detection of CT/NG	50 T/kit
	Real HSV 1/2^®	M152	Real-time PCR-based Assay System for Detection of HSV 1/2	50 T/kit

- Technical Specification

MolecuTech REBA HPV-ID^®

Features

Detect to HPV genotype of 18 species of high-risk, 1 species of medium-risk, and 13 species of low risk group at once
  - High risk group : HPV 16, 18, 26, 31, 33, 35, 39, 45, 51, 52, 53, 56, 58, 66, 59, 68, 69,73
  - Medium Risk group : HPV 34
  - Low risk group : HPV 6, 11, 32, 40, 42, 43, 44, 54, 70, 72, 81, 84, 87

Specimen : solid and liquid based specimen

High sensitivity and specificity

Rapid test within 2 hours after PCR reaction

Full automation of REBA procedure and Result analysis

Sensitivity and Specificity

Sensitivity : detects up to 100~1000 copies

Specificity : No cross reactivity other type above this 32 genotypes

		Data Interpretation

MolecuTech Real HPV 16/18/HR^®

Features

Detect HPV 16, HPV 18, and 12 high-risk HPV
- High risk group : HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, 68

Specimen : swab, preservative solution

High sensitivity and specificity

Rapid test within 2 hours after PCR reaction

Sensitivity and Specificity

Sensitivity : detects up to 100~1000 copies
   - HPV 16 : detect up to 50copy/rxn
   - HPV 18 : detect up to 50copy/rxn
   - HPV HR : detect up to 10²copy/rxn

Specificity : No cross-reactivity

		Data Interpretation

MolecuTech Real CT/NG^®

Features

Specimen : swab, preservative solution, urine

High sensitivity and specificity

Rapid test within 2 hours after PCR reaction

Sensitivity and Specificity

Sensitivity :
- CT : detect up to 50copy/rxn
- NG : detect up to 10²copy/rxn

Specificity : No cross-reactivity and interterence

		Data Interpretation

MolecuTech Real HSV 1/2^®

Features

Specimen : swab, preservative solution, urine

High sensitivity and specificity

Rapid test within 2 hours after PCR reaction

Sensitivity and Specificity

Specificity : No cross-reactivity and interterence

Sensitivity :
- HSV 1 : detect up to 25copy/rxn
- HSV 2 : detect up to 6copy/rxn

		Data Interpretation

Human Papilloma Virus(HPV) test

Product Name		Cat No.	Information	e-catalog
	HybREAD480	M-3	Fully Automated REBA Processor & Analyzer
	DX32	M-5	Automated Nucleic Acid Purification System

Information of Devices

HybREAD480^® is designed for full automation of strip assay from sample preparation to test results.

▣ HybREAD480^® Features

	ㆍ Fully-automated precessor after PCR process
	ㆍ Automatic sample dispensing by robotic pipettor
	ㆍ Accurate analysis using CMOS camera
	ㆍ Maximum of 48 samples
	ㆍ Operating software with excellent ease of use
	ㆍ Built-in UV lamp for prevention of contamination

▣ HybREAD480^® Structure

Technical Specifications

Test capacity	Max. 48 sample
Dispensing accuracy (ADP)	Less than or equal to 1.0 %
Detector type	CMOS camera
Run time	2.5 hours
Dimension (L×W×H)	1100 × 650 × 750

Sample Dispenser	Auto pipettor
Dispensing accuracy (pump)	Less than or equal to 10 %
Temp. Control (Tray)	Programmable multi-channel controller adjustable
Reagent	6 reagents
Weight	140 kg

▣ Applicable Reagent kit.
	ㆍREBA Myco-ID ㆍREBA MTB-MDR ㆍREBA MTB-XDR ㆍREBA HPV-ID

YD DX32 is a compact and reliable automated extraction platform in nucleic acid purification, based on the Magnetic Pillar technology, enabling successful delivery of extraction results of high quality nucleic acids for up to 32 samples from varied sample types.

■ Kit Content
- Reagent Plate (Pre-filled/nonprefilled)
- Proteinase K (1.3 ml)
- Mixing Sleeves (8-Tip combs)

▣ Feature
ㆍ Ready-To-Go Solution with prefilled 96 well plate cartridges and consumables	ㆍ Optimized Magnetic Pillar Technology Consistant and Reproducable purified Result
ㆍ Easy-To-Use User Interface multi-Language & intuitive UI with 7” Touchscreen-no external PC required	ㆍ Customizable Open System Platform Pre-filled Reagent plate and fully editable protocols
ㆍ Compact & light bench top instrument - fits in any laboratory
ㆍ Perfect Match of Magnetic Particle Separation

Technical Specifications

Extraction Method	Magnetic Beads Extraction Technology
Extraction Steps	Sample binding, washing, elution
Collection Efficiency	100 copies/mL, positive detecting rates > 95%
Test capacity	Max. 32 samples
TAT	Max. 40min

Operating Temp.	10-40ºC
Heat block Temp.	Up to 80ºC
Operating Relative Humidity	30 - 80%, no condensation
Dimension(W×L×H)	400mm × 420mm × 440mm
Decontamination	Built-in UV light

Ordering Information

Extraction kits	Cat No.
Extraction kits	64T/box	960T/box
DX32 Viral DNA & RNA Extraction kit	MDV64	MDV960
DX32 Bacteria Genomic DNA Extraction kit	MDB64	MDB960

Extraction kits	Cat No.
Extraction kits	64T/box	960T/box
DX32 Whole blood Genomic DNA Extraction kit	MDW64	MDW960
DX32 Tissue Genomic DNA Extraction kit	MDT64	MDT960

Device



	ㆍ Insert_MolecuTech Real-Time COVID-19
	ㆍ Fact Sheet for Healthcare Providers
	ㆍ Fact Sheet for Patients
	ㆍ Real-Time COVID-19 Rev.03 Leaflet
	ㆍ MSDS

YD’s MolecuTech® Real-Time COVID-19 test kit provides a solution to help laboratories address the urgent need for patient testing during the COVID-19 Pandemic. This multiplex real time PCR test kit consists of RdRP gene specific primer/probe to detect SARS-CoV-2 and E gene specific primer/probes for detecting all coronaviruses, and RNA extracted from respiratory specimens.

Features

ㆍDual target detection for RdRP and E gene

ㆍSpecific primer/probe mixture to increase its specificity

ㆍFast test results : 2 hours

Applicable Instruments

It is recommended to use either of the following diagnostic instruments:

Manufacturer	Model
Bio-Rad	CFX 96 real-time PCR detection system (CFX 96)
Thermo Fisher	Applied Biosystems 7500 Real-Time PCR Instrument System(ABI 7500)

Data Interpretation

COVID-19		Coronavirus
Internal Control		Positive Control

Contents

Contents	Cap Color	Quantity (100 Test)	Contents	Cap Color	Quantity (100 Test)
2X RT-PCR Premix	White	1000 ㎕	Positivie Control	White	50 ㎕
Primer / Probe Mixture	Brown	550 ㎕	Ultra Pure Water	White	550 ㎕

Real-Time COVID-19

- Test kit for detection of Fecal Occult Blood

Clinical Evaluation Report

- Clinical Biochemistry(Vol 38(2005) p.395-399, SCI Journal)
- Kangbuk Samsung Hospital & Sungkyunkwan University School of Medicine

Diagnostic Sensitivity & Specificity

- Correlation with Endoscopy: 100% in sensitivity & 98.9% in specificity

Analytical Sensitivity and No - Prozone effect

- Analytical sensitivity of OcculTech FOB Test is 50 ng/ml and no prozone effect appears upon 2,000 ng/ml.
Hemoglobin concentration of 2,000 ng/ml in diluent solution is 2 mg/g feces.



Test Procedure


Specification of Product

Test Device	Sample Collection Tube
Rapid test time : 5 minutes Detection Limit of Hemoglobin : 50 ng/mL Sensitivity of Product : 10 ~ 20 μg Hb/g Stool (can be detected by 200 mg/g) No dietary treatment required before test	Quantitative specimen collection (removal membrane of excess stool) High reproducibility Easy collection of specimen because of long collecting rod Requires small volume of specimen (ca. 10 mg) Easy handling

- Technical Specifications of Tumor markers

Product Name		Packages	Analytes	Features
TUMOR MARKER	OcculTech Fecal Occult Blood Rapid Test	20 tests(1 test X 20/Box) 100 tests(10 tests X 10/Box)	Occult blood	Immunochemical method Results within 5 minutes Sensitivity: 50ng/mL Hb in stool No dietary treatment required before test Specimen: Human stool
	ImmunTech AFP	30 tests(1 test X 30/Box) 100 tests(10 tests X 10/Box)	α-fetoprotein	Sensitivity: 20ng/mL Results within 5~10 minutes Specimen: Human serum/plasma
	ImmunTech CEA	30 tests(1 test X 30/Box)	Carcinoembryonic anitgen	Sensitivity: 5ng/mL Results within 5~10 minutes Specimen: Human serum/plasma
	ImmunTech PSA	30 tests(1 test X 30/Box	Prostate-specific anitgen	Sensitivity: 3ng/mL Results within 5~10 minutes Specimen: Human serum/plasma

Tumor marker test

Features

Fast, easy and convenient

Results in 15 minutes

Simple and easy to use

Requires no instruments and special skills

Whole Blood Test

Either whole blood , serum or plasma can be tested

Long shelf life

18 months shelf life

Store at room temperature

Sensitivity

0.5ng/mL of cardiac Troponin I

5ng/mL of CK-MB

50ng/mL of Myoglobin

Accuracy

Troponin I : 96.6%

CK-MB : 97.8%

Myoglobin : 97.1%

Specifications

Product name	Cardiac Triple Test
Cat. No	IM712-10
Test format	Cassette
Specimen	Serum, plasma, whole blood
Storage Temperature	4~25
Shelf life	18 months
Package	10 tests/kit

Reference

Myoglobin is a sensitive early marker elevating within 2 hours. Cardiac Troponin I (cTnI), CK-MB is released within 4~6 hours after
the onset of AMI certified specific to myocardium remaining elevated for up to 6~10 days. The Positive Predictive Values(PPVs) for Acute Coronary Syndrome by using three markers (cTnI , CK-MB and Myoglobin) were excellent better than single market

	Troponin I	Troponin T
Level in normal blood(ng/ml)	<0.2	<0.02
Cut-off level	0.5ng/ml	0.1ng/ml
Form in blood	free TnI, TnI complexed with one or more Troponin components, or troponin which has been partially degraded and chemically altered.	Free cTnT
Standardization of Calibrator	Lack of standardization between different assay	Good(Due to patent restrictions, assays for TnT are available from only one manufacturer)
Cardiospecificity	Very superiority	Superiority
Positive value for MI	>99%	94%
Positive value for UA	36%	22%
False positive	Rareness	Variety clinical condition

Cardiac marker test

- Clinical chemistry reagent

Product	Item No.	Package	Mixing ratio	Method	Reference Range
AST(GOT)	R201	R1 100mL×4 R2 100mL×2	4:1	IFCC	0~37 U/L
	A301	R1 20mL×10 R2 25mL×2
ALT(GPT)	R202	R1 100mL×4 R2 100mL×2	4:1	IFCC	0~40 U/L
	A302	R1 20mL×10 R2 25mL×2
Glucose	R203-T	R1 100mL×4 R2 100mL×2	4:1	Trinder	70~120 mg/dL
	A303-T	R1 20mL×10 R2 25mL×2
ALP	R204-D	R1 100mL×4 R2 100mL×2	4:1	Kinetic (DEA)	60~300 U/L (Child ＜ 700)
	A304-D	R1 20mL×10 R2 25mL×2
Amylase	R205	R1 100mL×4 R2 75mL×2	3:1	Gal-G2-CNP	39~115 Unit
	A305	R1 15mL×5 R2 25mL×1
Creatinine	R206	R1 100mL×4 R2 100mL×4	1:1	Jaffe-Kinetic	0.5~1.4 mg/dL
	A306	R1 100mL×2 R2 100mL×1
Uric Acid	R207	R1 100mL×4 R2 100mL×2	2:1	Trinder	M:3.6~8.0 mg/dL F:2.5~6.8 mg/dL
	A307	R1 40mL×4 R2 40mL×2
Cholesterol	R208	R1 100mL×4 R2 100mL×2	4:1	Trinder	130~250 mg/dL
	A308	R1 20mL×10 R2 25mL×2
HDL-Cholesterol	R208-H	R1 100mL×4 R2 75mL×2	3:1	Immunological Method	M:30~60 mg/dL F:38~72 mg/dL
	A308-H	R1 15mL×5 R2 25mL×1
LDL-Cholesterol	R208-L	R1 100mL×4 R2 75mL×2	3:1	Direct LDL Cholesterol	0~160 mg/dL
	A308-L	R1 15mL×5 R2 25mL×1
Chloridel	A309	100mL×2		Hg(SCN)2	96~107 mg/dL
Calcium	R210	R1 100mL×4 R2 100mL×4	1:1	OCPC	8.5~10.5 mg/dL
	A310	R1 100mL×1 R2 100mL×1
Bilirubin-Total	R211-T	R1 100mL×4 R2 100mL×2		DPD	0.2~1.0 mg/dL
	A311-T	R1 20mL×10
Brlirubin-Direct	R211-D	R1 100mL×4 R2 100mL×2		DPD	0~0.4 mg/dL
	A311-D	R1 20mL×10
T-Protein	R214	R1 100mL×4		Biuret	6.5~8.0 g/dL
	A314	R1 100mL×2
Albumin	R215	R1 100mL×4		BCG	3.7~5.2 g/dL
	A315	R1 100mL×2
Pi	A317	R1 100mL×1 R2 100mL×1	1:1	UV- Phosphomolybdate	2.5~4.5 mg/dL (Child : 4.0~7.0)
TG	R218	R1 100mL×4 R2 100mL×2	2:1	Trinder	10~200 mg/dL
	A318	R1 40mL×4 R2 40mL×2
γ-GT	R219	R1 100mL×4 R2 100mL×2	4:1	IFCC	M:0~50 U/L F:0~35 U/L
	A319	R1 20mL×10 R2 25mL×2
BUN	R220	R1 100mL×4 R2 100mL×2	4:1	Kinetic	5~23 mg/dL
	A320	R1 20mL×10 R2 25mL×2
LDH-P	R221	R1 100mL×4 R2 100mL×2	4:1	UV-Pyruvate	200~400 U/L
	A321	R1 20mL×5 R2 25mL×1
CK-NAC	R222	R1 100mL×4, R2 100mL×2	4:1	SCE	M:40~190 U/L F:30~165 U/L
	A322	R1 20mL×5 R2 25mL×1
Hemoglobin	H7	500mL×1		Cyanmethemoglobin	M:14.0~18.5 g/dL F:12.0~16.0 g/dL

- LIPID PROFILE Automated assays for clinical analyzers

The lipid profile is a group of tests comprising triglycerides, total cholesterol, HDL and LDL cholesterol.
The lipid profile is used, together with other risk factors, to assess a person's risk of cardiovascular disease (CVD).
It is very important to get the balance between the protective HDL and the destructive LDL right in order to reduce the risk of CVD.
This can be achieved either through dietary and lifestyle changes or treatment with cholesterol reducing drugs called statins.

Regular check-ups are necessary to establish risk and, if necessary, monitor treatment.

LIPID PROFILE		Cholesterol		HDL-C		LDL-C		Triglyceride
Inter-assay precision	n=20	Level 1	Level 2	Level 1	Level 2	Level 1	Level 2	Level 1	Level 2
	Mean	253.46	116.75	62.0	32.8	166.43	56.54	175.75	72.80
	SD	2.46	1.08	0.82	0.43	0.82	0.81	2.85	1.40
	CV(%)	1.54	0.96	1.47	1.94	0.491	1.428	1.8	1.8
Onboard stability (at 10˚C)		28 days		28 days		28 days		21 days
Linearity (mg/dl)		1000		2859		520		1200
Low detection limit (mg/dl)		0.15		2.86		0.16		0.65
Interferences (mg/dl)	Hemoglobin	500		500		1000		500
	Bilirubin	20		20		20		20
	Ascorbic acid	50		250		200		50

Reagents for multiple auto-analyzer

- Clinical chemistry reagent

Product	Item No.	Package	Mixing ratio	Method	Reference Range
AST(GOT)	R201	R1 100mL×4 R2 100mL×2	4:1	IFCC	0~37 U/L
	A301	R1 20mL×10 R2 25mL×2
ALT(GPT)	R202	R1 100mL×4 R2 100mL×2	4:1	IFCC	0~40 U/L
	A302	R1 20mL×10 R2 25mL×2
Glucose	R203-T	R1 100mL×4 R2 100mL×2	4:1	Trinder	70~120 mg/dL
	A303-T	R1 20mL×10 R2 25mL×2
ALP	R204-D	R1 100mL×4 R2 100mL×2	4:1	Kinetic (DEA)	60~300 U/L (Child ＜ 700)
	A304-D	R1 20mL×10 R2 25mL×2
Amylase	R205	R1 100mL×4 R2 75mL×2	3:1	Gal-G2-CNP	39~115 Unit
	A305	R1 15mL×5 R2 25mL×1
Creatinine	R206	R1 100mL×4 R2 100mL×4	1:1	Jaffe-Kinetic	0.5~1.4 mg/dL
	A306	R1 100mL×2 R2 100mL×1
Uric Acid	R207	R1 100mL×4 R2 100mL×2	2:1	Trinder	M:3.6~8.0 mg/dL F:2.5~6.8 mg/dL
	A307	R1 40mL×4 R2 40mL×2
Cholesterol	R208	R1 100mL×4 R2 100mL×2	4:1	Trinder	130~250 mg/dL
	A308	R1 20mL×10 R2 25mL×2
HDL-Cholesterol	R208-H	R1 100mL×4 R2 75mL×2	3:1	Immunological Method	M:30~60 mg/dL F:38~72 mg/dL
	A308-H	R1 15mL×5 R2 25mL×1
LDL-Cholesterol	R208-L	R1 100mL×4 R2 75mL×2	3:1	Direct LDL Cholesterol	0~160 mg/dL
	A308-L	R1 15mL×5 R2 25mL×1
Chloridel	A309	100mL×2		Hg(SCN)2	96~107 mg/dL
Calcium	R210	R1 100mL×4 R2 100mL×4	1:1	OCPC	8.5~10.5 mg/dL
	A310	R1 100mL×1 R2 100mL×1
Bilirubin-Total	R211-T	R1 100mL×4 R2 100mL×2		DPD	0.2~1.0 mg/dL
	A311-T	R1 20mL×10
Brlirubin-Direct	R211-D	R1 100mL×4 R2 100mL×2		DPD	0~0.4 mg/dL
	A311-D	R1 20mL×10
T-Protein	R214	R1 100mL×4		Biuret	6.5~8.0 g/dL
	A314	R1 100mL×2
Albumin	R215	R1 100mL×4		BCG	3.7~5.2 g/dL
	A315	R1 100mL×2
Pi	A317	R1 100mL×1 R2 100mL×1	1:1	UV- Phosphomolybdate	2.5~4.5 mg/dL (Child : 4.0~7.0)
TG	R218	R1 100mL×4 R2 100mL×2	2:1	Trinder	10~200 mg/dL
	A318	R1 40mL×4 R2 40mL×2
γ-GT	R219	R1 100mL×4 R2 100mL×2	4:1	IFCC	M:0~50 U/L F:0~35 U/L
	A319	R1 20mL×10 R2 25mL×2
BUN	R220	R1 100mL×4 R2 100mL×2	4:1	Kinetic	5~23 mg/dL
	A320	R1 20mL×10 R2 25mL×2
LDH-P	R221	R1 100mL×4 R2 100mL×2	4:1	UV-Pyruvate	200~400 U/L
	A321	R1 20mL×5 R2 25mL×1
CK-NAC	R222	R1 100mL×4, R2 100mL×2	4:1	SCE	M:40~190 U/L F:30~165 U/L
	A322	R1 20mL×5 R2 25mL×1
Hemoglobin	H7	500mL×1		Cyanmethemoglobin	M:14.0~18.5 g/dL F:12.0~16.0 g/dL

- LIPID PROFILE Automated assays for clinical analyzers

LIPID PROFILE		Cholesterol		HDL-C		LDL-C		Triglyceride
Inter-assay precision	n=20	Level 1	Level 2	Level 1	Level 2	Level 1	Level 2	Level 1	Level 2
	Mean	253.46	116.75	62.0	32.8	166.43	56.54	175.75	72.80
	SD	2.46	1.08	0.82	0.43	0.82	0.81	2.85	1.40
	CV(%)	1.54	0.96	1.47	1.94	0.491	1.428	1.8	1.8
Onboard stability (at 10˚C)		28 days		28 days		28 days		21 days
Linearity (mg/dl)		1000		2859		520		1200
Low detection limit (mg/dl)		0.15		2.86		0.16		0.65
Interferences (mg/dl)	Hemoglobin	500		500		1000		500
	Bilirubin	20		20		20		20
	Ascorbic acid	50		250		200		50

Reagents for auto-analyzer & spectrophotometer

Papanicolau Stain (Pap Stain)

Intended use
	Papanicolaou stain is used for detection of early neoplastic changes in the uterine cervix. The primary purpose of obtaining a sample of cells from the cervix (Papanicolau smear) is to detect to cervical cancer, its precursors, and other abnormalities of the reproductive tract.

Feature
	EASYSTAIN Harris Hematoxylin and EASYSTAIN Gill’s-II Hematoxylin do not contain mercury oxide which can be very harmful to human body.

Results read

ㆍNuclei	- Blue-Violet	ㆍKeratinized cytoplasmic	- From Pink to Orange
ㆍCyanophil cytoplasm	- Blue-green	ㆍBlood cell	- Yellow
ㆍEosinophil cytoplasm	- Pink
Malignant tumor cells generally have a large nucleus and few cytoplasms. Nucleus has a distinct nucleolus and the size, shape and stainability of the cells are also not regular. Usually have darker staining (hyper chromic) and various features such as sometimes seen the appearance of irregular or atypical mitoses.

Papanicolau Stain kit.

ITEM		Item No.	PACKAGE
Papanicolau Stain	EASYSTAIN Harris Hematoxylin	S2-5	1,000 ml × 1
	EASYSTAIN Gill’s-2 Hematoxylin	S2-6	1,000 ml × 1
	EA-50	S2-2	500 ml × 1
	OG-6	S2-3	500 ml × 1

Papanicolau Stain

AFB Stain

Gram Stain

YD Wright Stain

Intended use
	The Wright Stain is used for staining of the human blood cells, especially differential cell count.

Background
	Wright Stain is a solution which contains acidic dye, eosin, and alkaline dye, methylene blue, and dyes the acidic group or alkaline group containing a lot of components in each color.

Results read

Erythrocytes	- Pink line
Leucocytes, nuclear of lymphocytes	- Blue-violet line
Cytoplasm of Neutrophilic Leucocyte	- Pink line
Cytoplasm of acidophilic Leucocyte	- Blue line
Lymphocyte cytoplasm	- Light Blue line
Granules of Neutrophilic Leucocyte	- Light purple line
Granules of Basophilic Leucocytes	- Purple line
Granules of Eosinophilic Leucocytes	- Orange line
Platelet	- Purple line

Wright Stain kit.

ITEM		Item No.	PACKAGE
Wright Stain	Set (Wright Stain, buffer)	H1	500ml × 2
	YD Wright Buffer	H1-1	500ml × 1
	YD Wright Stain	H1-2	500ml × 1
	YD Wright Buffer	H1-3	2,000ml × 1
	YD Wright Stain	H1-4	2,000ml × 1

Wright Stain

EASYPREP^® System is a liquid-based cytology specimen collection, preservation and automated slide preparation system that produces standardized thinlayer slides for cervical cytology specimens and other non-gynecologic cytology specimens.

Features

	*High Cellularity* - By adopting sedimentation and centrifuge method / No cell loss
	*Automation* - Total walk-away system : the world first processor with a built-in centrifuge
	*Select Mode* - Both GYN and Non-GYN tests are possible at the same time - Various options are available to smear specific samples
	*Customization* - Easy adjustment of the parameter in accordance with laboratory requirement
	*Clarity* - Proper separation of mucus, inflammation cell and supernatants - Cell shape and structure(morphology) are well maintained - Clinically significant cells are evenly distributed for an easier reading
	*Barcode module (option)* - Preventing cross-contamination : EASYPREP system analyzes the barcodes on slides and sample(vial) for match.

Ancillary Test

HPV test

Reference

1. Cytological Evaluation and REBA HPV-ID HPV testing of Newly Developed Liquid-Based Cytology, EASYPREP : Comparison with SurePath.
The Korean Journal of Pathology 2013; 47: 265-274. Lee YS, Gong GY, Sohn JH, Ryu KS, Lee JH, Khang SK, Cho KJ, Kim YM, Kang CS.,

2.Comparison of EASYPREP and SurePath in Thyroid Fine-Needle Aspiration.
Diagnostic Cytopathology, Vol.44, No 4. Yosep Chong, Ki Hyun Baek, Jee Young Kim, Tea-Jung Kim, Eun Jung Lee, and Chang Suk Kang.

Technical Specifications

Operation	Full Automation
Principle	Sedimentation
Circle of smear	15mm
Certifications	KFDA, CE

Dimension	1300mm(W) × 800mm(D) × 1450mm(H)
Weight	450Kg
Quickness	56T/H
Ancillary test	Possible

Product line.

Item.		Item. No.	Package
Preservative Solution	GYN	GY01	12ml × 16ea / box
Preservative Solution	NonGYN	NGY01	12ml × 16ea / box
Reagent	Gradient density reagent	EZ02	1,000ml
	Suspension buffer	EZ03	1,000ml
	Fixative solution	EZ04	1,000ml
	Rinse solution	EZ05	1,000ml
Consumables	Coated slide glass	EZ06	64ea / box
	Slide chamber	EZ07	64ea / pack
	5ml Tip	EZ09	200ea × 2 pack / box
	Centrifuge tube	EZ10	200ea/box
	Vial plug	EZ12	64ea / pack
	Brush	EZ16	1ea / pack
	Brush	EZ11	10ea / pack

EASYPREP

URiSCAN MolecuTech ImmunTech AceChem Stain EASYPREP

PCR-based Assay for TB	Home > Product > URiSCAN > PCR-based Assay for TB

Product name		Cat No.	Information	Unit
- Polymerase Chain Reaction(PCR)
	MolecuTech TB-Tag Two^®	M012	Two-tube Nested PCR-based Assay System for Detection of only MTB among MTB complex	50 T/kit
	MolecuTech MTB-ID V3^®	M024	PCR-based Assay System for Simultaneous Detection of MTB and Other Mycobacteria	100 T/kit
- Real time PCR
	MolecuTech Real TB-Tag^®	M034	Real-time PCR-based Assay System for Detection of only MTB among MTB complex	100 T/kit
	MolecuTech Real MTB-ID^®	M144	Real-time PCR-based Assay System for Simultaneous Detection of MTB and Other Mycobacteria	100 T/kit
- Reverse Blot Hybridization Assay(REBA)
	MolecuTech REBA Myco-ID^®	M067	Reverse Blot Hybridization Assay System for Identification of Mycobacterial Species Including MTB	48 T/kit
	MolecuTech REBA MTB-MDR^®	M119	Reverse Blot Hybridization Assay System for Determination of Rifampin and Isoniazid Susceptibility of MTB	24 T/kit
	MolecuTech REBA MTB-XDR^®	M129	Reverse Blot Hybridization Assay System for Determination of Fluoroquinolone, Kanamycin and Streptomycin Susceptibility of MTB	24 T/kit

- Technical Specification

Features

Rapid and accurate detection only MTB among MTB complex

Specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen

High specificity and sensitivity with two-tube nested PCR

All in one system : from DNA extraction to agarose gel electrophoresis of PCR product

Internal control is included, determining existence of PCR inhibitor within specimens

Sensitivity and Specificity

Sensitivity : detect up to 2 ~20 bacilli

Specificity : detect specific target region for only MTB

Data Interpretation

Features

Rapid and accurate detection and differentiates MTB and NTM at DNA level simultaneously

Specimen : DNA of culture isolate

High specificity and sensitivity by application multiplex and one-tube nested PCR

All in one system : from DNA extraction to agarose gel electrophoresis of PCR product

Internal control is included, determining existence of PCR inhibitor within specimens

Sensitivity and Specificity

Sensitivity for MTB : detect up to 2~20 bacilli

Sensitivity for NTM : detect up to 200 bacilli

Specificity : no cross-reactivity between MTB and NTM

Data Interpretation

Features

Rapid and accurate detection

Specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen

High specificity and sensitivity

Simple procedure and closed system
- Not required gel electrophoresis
- Minimized to cross or carry-over contamination in process

DNA extraction solution included

Sensitivity and Specificity

Sensitivity : detect up to 2 ~20 bacilli

Specificity : detect specific target region for only MTB

Data Interpretation

Features

Rapid and accurate detection

Diverse clinical specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen

High specificity and sensitivity

Simple procedure and closed system
- Not required gel electrophoresis
- Minimized to cross or carry-over contamination in process

DNA extraction solution included

Sensitivity and Specificity

Sensitivity for MTB : detect up to 2~20 bacilli

Sensitivity for NTM : detect up to 200 bacilli

Specificity : no cross-reactivity between MTB and NTM

Data Interpretation

Features

Identification of 19 species of NTM

Diverse clinical specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen

High sensitivity and specificity by binding to species specific probe

Rapid test within 2 hours after PCR reaction

Useful for mixed or multiple infection of mycobacteria

Sensitivity and Specificity

Sensitivity for NTM : detect up to 20 bacilli

Specificity : identify MTB and 19 species of NTM (detect to over 100 species NTM)

Data Interpretation

Features

Rapid and accurate detection of rifampin and isoniazid resistance of MTB

Diverse clinical specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen (not required culture)

High sensitivity and specificity by binding to target gene specific probe
- Rifampin target : rpoB
- Isoniazid target : katG, inhA, and ahpC intergenic region

Rapid test within 2 hours after PCR reaction

Sensitivity and Specificity

Sensitivity : detect up to 20 bacilli

Specificity : detect drug susceptibility for rifampin and isoniazid of MTB

Data Interpretation

Features

Rapid and accurate detection extensively drug-resistance (XDR) of MTB

Diverse clinical specimen : sputum, bronchial washed solution, body fluid, tissue, and cultured specimen (not required culture)

High sensitivity and specificity by binding to target gene specific probe

Rapid test within 2 hours after PCR reaction

Sensitivity and Specificity

Sensitivity for NTM : detect up to 20 bacilli

Specificity : detect drug susceptibility for kanamycin, fluoroquinolone and streptomycin of MTB

Data Interpretation






Test Principle
	Classical morphology detection, provide whole view field microscopic image
	Machine vision technology (MV)
	Coordinate position tracking recognition technology (CPTR)
	Real-time dynamic intelligent focus technology (DIF)

Intended use
	This stain is used to differentiate the genus Mycobacterium from most other bacteria.