
REALQUALITY RQ-CMV is a test kit for the detection and quantification of Cytomegalovirus (CMV) DNA by qPCR in blood, plasma, or other clinical samples.
Quality standards: CE-IVD - Class D medical device with a marketing authorization under Decree No. 98/2021/ND-CP
The product is optimized for laboratories that require high accuracy and high-efficiency operating procedures.
Overview of Cytomegalovirus (CMV):
Biological characteristics: Cytomegalovirus (CMV) is a virus of the Herpesviridae family (also known as Human betaherpesvirus 5). It is a common virus with a very high prevalence in the community, ranging from 40% to 100% depending on geographic region and living conditions.
Pathogenesis: In people with a healthy immune system, CMV infection usually progresses silently without obvious clinical symptoms. However, the virus tends to reactivate and cause severe disease in vulnerable groups such as newborns, organ transplant recipients, cancer patients, people living with HIV, the elderly, or people who have received blood transfusions or undergone splenectomy.
Viral shedding: CMV can replicate in many organs (lungs, liver, kidneys, gastrointestinal tract...) and is continuously shed through body fluids such as saliva, breast milk, urine, semen, genital secretions, feces and blood.
The REALQUALITY RQ-CMV test kit is an in vitro diagnostic solution based on the Real-Time PCR technique for the accurate detection and quantification of CMV DNA, serving as a powerful support tool in clinical management through the following main applications:
Accurate detection and quantification of CMV DNA: Provides reliable technical data on the presence and load of the virus from a wide range of clinical sample sources, giving physicians a basis for identifying active infections.
Support for monitoring high-risk groups: Provides standardized quantitative data for routine screening of immunocompromised patients or patients with an immature immune system, supporting early detection of the risk of multi-organ viral involvement.
Monitoring of treatment response and efficacy: Tracks changes in viral DNA levels throughout medical intervention, helping physicians assess disease progression and monitor the efficacy of CMV infection therapies.
Supporting preventive medicine and research: Provides standardized molecular biology data for epidemiological surveillance, assessment of virus prevalence, and in-depth scientific research on CMV in Vietnam.
Professional Note
Please read the instructions for use (IFU) carefully before performing the test. Contact a Viet Huy technical specialist for on-site validation support in your laboratory.
Accurate detection and quantification of CMV DNA: Provides reliable technical data on the presence and load of the virus from a wide range of clinical sample sources, giving physicians a basis for identifying active infections
Support for monitoring high-risk groups: Provides standardized quantitative data for routine screening of immunocompromised patients or patients with an immature immune system, supporting early detection of the risk of multi-organ viral involvement
Monitoring of treatment response and efficacy: Tracks changes in viral DNA levels throughout medical intervention, helping physicians assess disease progression and monitor the efficacy of CMV infection therapies
Supporting preventive medicine and research: Provides standardized molecular biology data for epidemiological surveillance, assessment of virus prevalence, and in-depth scientific research on CMV in Vietnam
Contact the Viet Huy technical team for more information.
| Product name | REALQUALITY RQ-CMV |
| Product code | RQ-09 |
| Technology | Real-time PCR (qPCR) |
| Manufacturer | AB Analitica S.r.l. - Italy |
| Certifications | CE-IVD |
| Limit of Detection (LoD) | 2.54 to 4.29 copies/reaction |
| Linear range | from 5 to 107 copies/reaction |
| Specificity | 98.7% to 99.9% |
| Sensitivity | 96.4% to 99.9% |
| Sample source | Whole blood, plasma, serum, cerebrospinal fluid (CSF), amniotic fluid, urine, lymphocyte pellets and buccal swabs |
| Components | Reagents are supplied pre-mixed in a ready-to-use format, with an integrated dUTP/UNG system to eliminate carryover contamination |
| Quantification standards | 4 ready-made quantification standards with concentrations from 102 to 105 copies/reaction |
| Compatibility | Thermal protocol harmonized with other REALQUALITY kits for infectious diseases, designed to be suitable for both manual operation and the GENEQUALITY® 2050 automated system |
| Compatible systems | Common 4-channel Real-Time PCR systems (Sacyler 96, ABI 7500, Bio-Rad, CFX96, Rotor-Gene Q MDx, Roche LightCycler...) |
| Packaging | 100 tests/kit |
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