Cytomegalovirus nucleic acid kit

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Product Name	Genelys CMV
Generic Name	Cytomegalovirus nucleic acid kit
Approval Number	22900EZX00033000
Product Code	326065431
Tests per Kit	48 tests
Storage Conditions	-30～-20℃, protected from light
Shelf Life	1 year

Intended Use

Detection of cytomegalovirus (CMV) DNA in urine (can be used as an aid in diagnosing congenital CMV infection)

Clinical Significance

CMV primarily infects during early childhood in a subclinical form and remains latent throughout life. However, if CMV infection occurs in utero, it can result in low birth weight, liver dysfunction, microcephaly, and various other symptoms, often leading to neurological sequelae. Additionally, even asymptomatic newborns may later develop symptoms such as hearing loss.

Sample for Measurement

Urine collected from newborns within 3 weeks of birth.

The viral load in urine is 100 to 1000 times higher than in blood. Postnatal infection requires approximately 3 weeks for the virus to appear in urine. To distinguish congenital CMV infection from postnatal infection, urine must be collected within 3 weeks of birth.

Kit Contents

Reaction Mixture（R1）	0.55 mL x 2
Strand-displacing DNA polymerase（R2）	55 µL x 1
Sample treatment reagent	25 µL x 48 Well
Negative control	0.45 mL x 1
Positive control	0.45 mL x 1

Kit Features

Detects CMV-DNA in urine
Simple and quick measurement
No need for genome purification of the sample
Pre-treatment heating time: only 1.5 minutes

This kit allows for the rapid detection of CMV-DNA. For diagnosing congenital CMV infection, virus detection is necessary, either through CMV-DNA detection or virus isolation. Virus isolation is limited to certain facilities and can take several days to weeks for results. This product enables CMV-DNA detection by simply mixing a pre-treated sample with reagents and reacting for 60 minutes without genome DNA purification.

Measurement Principles

Amplification : SmartAmp®method: Uses strand-displacing DNA polymerase and multiple primers with specific sequences to perform nucleic acid amplification at a constant temperature (61℃).
Detection : Eprimer^TM: Fluoresces upon specific hybridization with the complementary strand, allowing specific detection of CMV-DNA amplification.

"SmartAmp" is a registered trademark of DNAFORM.

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Measurement Procedure

STEP1: Sample pretreatment: Add sample to the treatment reagent in a tube and heat it for 1.5 min.
STEP2: Preparation of reagent mixture: Mix Reagent 1 and Reagent 2
STEP3: Preparation of reaction mixture: Add pre-treated sample to the reagent mixture
STEP4: Amplification/Detection: 61℃ for 60 min. using Genelys GL-112 analytical device

Measurement Results

X-axis: Reaction Time (minutes)
Y-axis: Fluorescence Intensity

Features of Analytical Device

Space-saving: The operation unit and reaction block are integrated. Measurement and data analysis can be performed with this single device.
Easy Operation: Operated via a touch display. The operation proceeds interactively on the screen.

Product Name	Genelys GL-112
Approval Number	14B3X10019000001
Dimensions	W240 x D240 x H150mm
Weight	Approximately 4 kg
Simultaneous Measurement Samples	Up to 12
Temperature Accuracy	35～50℃ ±0.5℃ 50～80℃ ±1℃ >80℃ ±2℃
Heating/Cooling Rate	0.5℃/sec
Wavelength Excitation／Emission (nm)	520/570 625/720
Power Supply	100-240V 50/60Hz
Power Supply	100-240V 50/60Hz
External Connections	USB (Type A) x 4 USB (Type B) x 1
Data Storage	Up to 1000 tests
Operation Methos	Touch Display Operation
Languages	English, German

Optional Accessories

Product Code	326077328
Product Name	0.2 mL PCR 8-Strip Tubes with Flat Caps
Kit Contents	120 stripes