Epstein– Barr Ebv PCR Detection Kit

• Type: IVD Reagent
• Accuracy: Conformity Rate of 12 Negative Control: 100%
• Detection Limitation: 500 Copies /Ml
• Cross-Reactivity: No
• CT Values: ≤ 5.0%
• Technology: Real-Time Fluorescent PCR Amplification
• Model NO.: EBV
• Store: -25°c to -18°c
• Shelf Life: 12 Months
• Supporting Instruments: Real-Time PCR Instrument with Fam and Vic Channels
• Specimen: Plasma
• Certification: CE
• Transport Package: Box and Carton
• Specification: 48 Tests/kit
• Trademark: CAS-Envision
• Origin: Shenzhen, Guangdong, China

Product Description

Epstein-Barr (EBV) Nucleic Acid Detection kit(PCR method)

Intended Use

The Epstein-Barr Virus (EBV), also known as Human Herpesvirus 4 (HHV-4), is a DNA virus in the Herpesvirus family. Most people are infected at some point, but only a small fraction develop disease. Children often show no symptoms or mild illness. Infections in adults can lead to Infectious Mononucleosis (IM) with symptoms like fever and sore throat. In Africa, EBV is linked to Burkitt's lymphoma, and in Southeast Asia to nasopharyngeal cancer. Reactivation of the virus usually occurs without symptoms. The EBV Nucleic Acid Detection kit (PCR method) uses real-time PCR to detect and quantify EBV-specific DNA.

Principles of the Assay

Using real-time fluorescent PCR amplification technology, the kit employs fluorescent labeled probes to monitor PCR product quantity by detecting fluorescent strength during amplification. Both detection and internal standard probes feature fluorescent reporter and quencher, differentiated by colored labels and detected independently at different wavelengths. Initially, the reporter is inhibited near the quencher when probes are intact. During PCR, probes hybridize with the targeted sequence, degraded by polymerase exonuclease activity, separating the fluorescent reporter and quencher for signal detection. Preset cycle time ensures an increase in fluorescent strength with every effective cycle.

Kit Components

Reagent	Volume	Quantily
Buffer A	900µL	×1 tube
Buffer B	100µL	×1 tube
Negative Control	400µL	×1 tube
Positive Control	400µL	×1 tube

Performance Specifications

1. Accuracy: Conformity rate of 12 Negative Control: 100%; Conformity rate of 5 Positive Control: 100%. 
2. Detection limitation: 500 copies /mL.
3. Inclusiveness: The LOD and repeatability of virus samples from different regions will not change.
4. Cross-Reactivity: This product will not cross react with positive samples of herpes simplex virus, influenza virus, adenovirus, Respiratory syncytial virus, hepatitis B and hepatitis C.
5. Interfering Substances Studies: Endogenous substances such as blood and mucus that may be present in throat swabs and sputum samples do not interfere with the test results of the kit; exogenous substances such as phenylephrine, oxymetazoline, sodium chloride, and beclomethasone, flunisolide, budesonide, mometasone, fluticasone, histamine hydrochloride, alpha-interferon, zanamivir, ribavirin, oseltamivir, peramid Wei, lopinavir, ritonavir, arbidol, levofloxacin, azithromycin, ceftriaxone, meropenem, tobramycin did not interfere with the test results.
6. Precision: using precision reference CV1 and CV2 for within-batch and between-batch detection, the coefficient of variation (CV) of their Ct values is ≤ 5.0%.
 

Certifications

Production Capabilities

Manufacturer Introduction

Founded in 2018, CAS-Envision is a high-tech start-up company held by Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences.
CAS-Envision is committed to creating an operating system of semiconductor and biomedical interconnection, to provide unique one-stop technical solutions for lVD and biopharma.ceutical companies. The company has established three major business segments: One is POCT, including lmmunochromatography, molecular POCT, electrochemical detection). Second is ultra-sensitive detection, like digital PCR, single moleculeimmunity. Third is medical chips for brain-computer interface, sensor chip, medical SoC chip.