Home Health & Medical Medical Devices Monitoring & Diagnostic Equipment Other Monitoring & Diagnostic Equipment

Ezplex SARS-CoV-2 G Kit (FAST)

Medical equipment reagent

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Negotiable Min Order Quantity Unit

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Place of Origin: South Korea

Payment Terms: T/T

Production method: Available

Shipping / Lead Time: Negotiable / Negotiable

Keyword: fast, real-time, covid, molecular diagnosis

Category: Other Monitoring & Diagnostic Equipment

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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 SARS-CoV-2 G Kit (FAST)	Certification	CE
Category	Other Monitoring & Diagnostic Equipment	Ingredients	-
Keyword	fast , real-time , covid , molecular diagnosis	Unit Size	-
Brand name	-	Unit Weigh	-
origin	South Korea	Stock	500000
Supply type	Available	HS code	382200

Product Information

The Ezplex® SARS-CoV-2 G Kit (FAST) is a real-time reverse transcription polymerase chain reaction (rRT-PCR) test.The 2019-nCoV primer and probe set(s) is designed to detect RNA from the SARS-CoV-2 Virus in Upper Respiratory(Nasopharyngeal/Oropharyngeal) swabs and Lower Respiratory specimens(Sputum) from patients with signs and symptoms of infection who are suspected of COVID-19.

Workflow

Compatible Device

CFX96 Real-time PCR Instrument

QuantStudio 6 Flex Real-time PCR Instrument

Performance Evaluation

1) Analytical Sensitivity

Using standard SARS-CoV-2 material, it was serially spiked in both of Upper respiratory(Nasopharyngeal) and Lower respiratory specimens(Sputum), and RNA were extracted from those prepared specimens. The test was performed 20 times on every diluted concentrations and the limit of detection is calculated as below using probit analysis of 95% positive rate.

Target	CFX96		QuantStudio 6 Flex
Target	Upper	Lower	Upper	Lower
RdRp	1.585 copies/uL	1.367 copies/uL	2.587 copies/uL	2.587 copies/uL
N	1.045 copies/uL	1.259 copies/uL	2.272 copies/uL	1.887 copies/uL

2) Analytical Specificity

2.1) Cross reactivity

The 15 species of microorganisms, which are expected of cross reactivity, are chosen for the test and the test repeated three times on every chosen species. As a result of the test, there were no cross reactivity as those were observed as all negative result.

Microorganism	SARS- CoV-2 (O)	SARS-CoV-2 (X)	Microorganism	SARS- CoV-2 (O)	SARS- CoV-2 (X)
Influenza A H3	Pos	Neg	Coronavirus 229E	Pos	Neg
Influenza B	Pos	Neg	Enterovirus 71	Pos	Neg
Bordetella pertussis	Pos	Neg	Adenovirus	Pos	Neg
Respiratory Synncytial virus B	Pos	Neg	Rhinovirus	Pos	Neg
Parainfluenza virus 1-3	Pos	Neg	Bordetella parapertussis	Pos	Neg
Coronavirus OC43	Pos	Neg	Legionella pnermophila	Pos	Neg
Coronavirus NL63	Pos	Neg

2.2) Interference

The interference materials were prepared with 3 materials of endogenous - Albumin (0.24g/mL), Hemoglobin (0.2g/mL), Bilirubin (0.05mg/mL) - those were tested three times with and without positive materials of SARS-CoV-2 diluted in low concentration. As a result of the test, there were no interference by observing the coefficient of variation(CV) value which were less than 5% in all cases.

Controls	Interference
	Albumin		Hemoglobin		Billirubin
	O	X	O	X	O	X
SARS-CoV-2 Virus	Positive (CV 5%>)	Positive	Positive (CV 5%>)	Positive	Positive (CV 5%>)	Positive
Negative control	Negative	Negative	Negative	Negative	Negative	Negative

3) Analytical Precision

3.1) Analytical Precision (Reproducibility)

A reference material for SARS-CoV-2 Virus(Vircell, MBC137-R) was diluted into middle concentration (100 copies/uL) and low concentration (5 copies/uL). It was tested together with negativity (D.W) using 1 Lot by 2 investigators and each investigator tested several times repeatedly. The detection results were same across the tests with CV < 5%, and it was confirmed that results did not differ between investigators.

3.2) Analytical Precision (Repeatability)

A reference material for SARS-CoV-2 Virus(Vircell, MBC137-R) was diluted into middle concentration (100 copies/uL) and low concentration (5 copies/uL). It was tested together with negativity (D.W) using 2 Lots by 1 investigator and the investigator tested 10 times repeatedly, 5 times a day for 2 days. All the detection results were same with CV < 5%, and it was confirmed that results did not differ within a test, between tests and between lots.

4)Clinical Evaluation

The clinical performance was evaluated by a clinical performance testing institution in Republic of Korea using the left-over upper respiratory (nasopharyngeal and oropharyngeal) and lower respiratory (sputum) specimens that were positive and negative through the emergency use approved product (Kosen Biotech, PowerchekTM 2019-nCoV Real-time PCR kit) by Korea CDC, and the results are as follows.

(1) CFX96 Real-time PCR Instrument

Upper (Nasopharyngeal/ Oropharyngeal)		Reference			Lower (Sputum(		Reference
		Positive	Negative	Total			Positive	Negative	Total
Ezplex®	Positive	99	0	100	Ezplex®	Positive	99	0	100
	Negative	1	100	100		Negative	1	100	100
	Total	100	100	200		Total	100	100	200
Sensitivity (95% CI)		99 % (94.55 ~ 99.97 %)			Sensitivity (95% CI)		99 % (94.55 ~ 99.97 %)
Specificity (95% CI)		100 % (96.38 ~ 100 %)			Specificity (95% CI)		100 % (96.38 ~ 100 %)

(2) QuantStudio 6 Flex Real-time PCR Instument

Upper (Nasopharyngeal/ Oropharyngeal)		Reference			Lower (Sputum(		Reference
		Positive	Negative	Total			Positive	Negative	Total
Ezplex®	Positive	30	0	30	Ezplex®	Positive	30	0	30
	Negative	0	30	30		Negative	0	30	30
	Total	30	30	60		Total	30	30	60
Sensitivity (95% CI)		100 % (88.43 ~ 100 %)			Sensitivity (95% CI)		100 % (88.43 ~ 100 %)
Specificity (95% CI)		100 % (88.43 ~ 100 %)			Specificity (95% CI)		100 % (88.43 ~ 100 %)

Kit Components

* 50 tests

No.	Kit Component	Volume	Lid Remarks
1	RQ Mixture	1 vial, 600uL	RQ
2	RdRp P+P	1 vial, 200uL	RdRp
3	N P+P	1 vial, 200uL	N
4	Positive Control	1 vial, 100uL	PC
5	Negative Control	1 vial, 100uL	NC
6	Internal Control	1 vial, 20uL	IC

* 100 tests

No.	Kit Component	Volume	Lid Remarks
1	RQ Mixture	2 vials, 600uL	RQ
2	RdRp P+P	2 vials, 200uL	RdRp
3	N P+P	2 vials, 200uL	N
4	Positive Control	1 vial, 100uL	PC
5	Negative Control	1 vial, 100uL	NC
6	Internal Control	1 vial, 20uL	IC