Home Health & Medical Medical Devices Examination & Testing Instrument Medical Test Kit

Ezplex HP-CLA Real-time PCR Kit

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Place of Origin: South Korea

Payment Terms: Negotiable

Production method: Negotiable

Shipping / Lead Time: Negotiable / Negotiable

Keyword: test, diagnosis reagent, ivd, pyiori

Category: Medical Test Kit

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SML Genetree Co.,Ltd.

Country / Year Established: South Korea / 2015

Business type: Manufacturer

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PRODUCT DESCRIPTION COMPANY INFORMATION Related Products

Product name	Ezplex HP-CLA Real-time PCR Kit	Certification	-
Category	Medical Test Kit	Ingredients	-
Keyword	test , diagnosis reagent , ivd , pyiori	Unit Size	-
Brand name	-	Unit Weigh	-
origin	South Korea	Stock	-
Supply type	-	HS code	2852105000

Product Information

Ezplex^® HP-CLA Real-time PCR Kit is a reagent that uses the PCR method to qualitatively detect helicobacter pylori and clarismycin-resistant mutations from human driven gastric biopsy tissues. It can test 96 samples at once, quickly and easily with a short time PCR response, along with dedicated software to help you see the results.

▶Analytical Sensitivity

Repeated tests with serial dilutions of the standard material have confirmed the high analytical sensitivity of Ezplex^® HP-CLA Real-time PCR Kit

Target		Limit of Detection (copies/㎕)
Helicobacter pylori		3.604
Clarithromycin resistance mutations	A2142G	4.174
	A2143G	4.626

▶Reproducibility

Reproducibility tests using standard materials all showed stable results of less than 5% CV.

Target		Density	Mean	CV (5%)
Helicobacter pylori		Medium concentration	30.81	1.14
Helicobacter pylori		Low concentration	34.51	0.88
Clarithromycin resistance mutations	A2142G	Medium concentration	31.03	0.84
	A2142G	Low concentration	34.39	0.84
	A2143G	Medium concentration	30.93	0.83
	A2143G	Low concentration	34.19	0.92

▶Stability

Ezplex^® HP-CLA Real-time PCR Kit was tested reapeatedly at the initial time point and at each storage point for 6 months and 12 months, and both showed CV less than 5%, confirming that it maintains stability.

Target		Density	Initial mean	6 months mean	12 months mean	Total CV (%)
Helicobacter pylori		Medium	31.00	31.41	31.57	1.17
Helicobacter pylori		Low	34.56	35.06	35.27	1.28
Clarithromycin resistance mutations	A2142G	Medium	31.15	31.61	31.90	1.05
	A2142G	Low	34.47	34.95	35.37	1.12
	A2143G	Medium	31.02	31.46	31.65	0.93
	A2143G	Low	34.02	34.58	34.90	1.14

▶Clinical Accuracy

In a test conducted by the general clinical laboratories in Korea using human stomach biopsy samples that were already confirmed by the KFDA(Korea Food and Drug Ministration), our high clinical performance was validated.

Helicobacter pylori		Control group (licensed product)
		Positivity	Negativity
Ezplex^®HP-CLA Real-time PCR Kit	Positivity	82	0
	Negativity	0	66
Clinical sensitivity (95%CI)		100% (95.60~100%)
Clinical specificity (95%CI)		100% (94.56~100%)

A2142G		Control group (licensed product)
		Positivity	Negativity
Ezplex^®HP-CLA Real-time PCR Kit	Positivity	47	0
	Negativity	0	66
Clinical sensitivity (95%CI)		100% (92.45~100%)
Clinical specificity (95%CI)		100% (94.56~100%)

A2143G		Control group (licensed product)
		Positivity	Negativity
Ezplex^®HP-CLA Real-time PCR Kit	Positivity	70	0
	Negativity	0	66
Clinical sensitivity (95%CI)		100% (94.87~100%)
Clinical specificity (95%CI)		100% (94.56~100%)

▶Ordering information

Ezplex^®HP-CLA Real-time PCR Kit includes Taq Polymerase, Primer&Probe, Positive control and Internal control.

Product Classification	Product size	Purpose of use
Ezplex^®HP-CLA Real-time PCR Kit	100 reaction	IVD, RUO
Ezplex^®HP-CLA Real-time PCR Kit	200 reaction	IVD, RUO