Medical Products Supplies Companies

Via Svizzera, 16, 35127 Padova
Italy
Telephone +39 049 761698
Fax +39 049 8709510
sales@abanalitica.it
http://www.abanalitica.com

Product Categories

Product categories

03 Diagnostic Tests
03.06 Genetic testing, molecular diagnostics
03.06.01 DNA testing

DNA testing

03 Diagnostic Tests
03.07 Other diagnostics

Other diagnostics
Our products

Product category: DNA testing
REALQUALITY RQ-CMV
Description
REALQUALITY RQ-CMV is a diagnostic CE-IVD kit for the identification and quantification of the DNA of Human Cytomegalovirus (CMV) by Real time PCR.

Peculiarity

The device is validated on DNA extracted from various samples types
The assay requires only 5 µL of DNA extracted
If used in combination with the REALQUALITY RQ-CMV STANDARD, it allows the quantification of the viral DNA present in the sample
The assay shares the same thermal profile of the REALQUALITY Infectious diseases kits
Validated on main Real time PCR instruments
The assay includes dUTP/UNG system for preventing carry-over contamination and a fluorescence normalizer
The automatic format of the assay can be used on GENEQUALITY X120platform
Easy interpretation of results with AB Genius Report software

Kit content

Ready-to-use reagents for Real time PCR
Internal control (amplification of beta-globin gene – BG)
Positive control (DNA containing fragments of the CMV genome and the BG gene)

For further informations
Cytomegalovirus (CMV) belongs to the family of herpes viruses; it is a ubiquitous virus with a very slow replication cycle, and after primary infection it remains dormant in the body for life.
In most healthy individuals, whether paediatric or adult, the disease has no symptoms, although in some individuals it may cause a slight feverishness, sore throat, fatigue and swollen lymph nodes. The preferential sites of viral replication in humans are the lungs, liver, kidneys and gastrointestinal tract. The virus is continuously eliminated via the saliva, breast milk, seminal fluid, urine, cervical and vaginal secretions, tears, faeces and blood.
Relevant aspects of CMV infection are related to congenital infections and immunocompromised patients. The virus can be transmitted from the mother to the foetus in the event of a primary infection during pregnancy, during passage through the birth canal, or through breastfeeding (perinatal and neonatal infection), causing intellectual disability and deafness.
CMV infection is also clinically relevant in immunocompromised patients, such as organ transplant recipients and people with AIDS. In these cases, the determination and monitoring of the viral load are fundamental to the clinical-therapeutic decision.

Why use a Real time PCR assay for CMV?
The investigation of CMV using Real-Time PCR (polymerase chain reaction) is essential for the detection of congenital infection, the timely identification of viral reactivation in organ transplant recipients and their subsequent follow-up.

Product category: DNA testing
GENEQUALITY Lysis Buffer SW
Kit for rapid extraction of viral and bacterial DNA from swabs and urine.

The kit includes:

Solution for fast lysis
Solution for dilution of the lysate

GENEQUALITY X120 and X120 TRACK

Product category: DNA testing
GENEQUALITY X120 and X120 TRACK
GENEQUALITY X120 is a completely automated CE IVD walk-away system to perform routine molecular diagnostics, optimizing efficiency and versatility. GENEQUALITY X120 can manage up to 64 biological samples simultaneously: from loading of sample to Real-Time PCR setup with different assays.

The GENEQUALITY X120 platform uses magnetic beads, in convenient preloaded cartridges, which guarantees excellent performance of nucleic acid extraction. The flexibility of the software allows for the maximum versatility of Real-Time PCR plate design.

EXTRACTION

Purification of DNA and RNA from different types of biological matrices in the same run
Up to 64 samples processed simultaneously from primary tube
A barcode reader guarantees the correct identification of samples and reagents
Every sample is singularly managed for starting volume, elution volume and pre-treatment options selectable by the operator
Preparation of PCR plate from 6 different elution plates
On-Board cooling block for storage of the reagents during PCR setup
Complete traceability of entire work flow

SOFTWARE

Software with touch-screen interface, maximum ease-of-use
Programmable PCR plate setups for type of assay and/or for elution plate, with the possibility to include/exclude groups of samples or single samples in the plate
Expiry Alarm (optional): suggests to the operator the samples with expiring analysis dates
Direct exportation of PCR configuration files to the most common Real-Time PCR instruments
Bidirectional interface to the laboratory management system
Furthermore is now available GENEQUALITY X120 Track version. This platform is designed to allow maximum versatility for the operator, and in the same time, it suggests solutions and useful optimizations for efficient management of diagnostic routine.

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About Us

Company details
AB ANALITICA was established in the year 1990 in Padua in the Veneto region (north-east Italy) and is a company is specialized in the development and the sale of diagnostic systems for professional use. Through our highly qualified and committed researchers as well as constant collaboration with research institutes, universities, and hospitals we have gained the scientific knowledge and experience that allow AB ANALITICA to develop and produce high-quality, innovative and safe diagnostic systems that are in line with the most recent medical guidelines.

We at AB ANALITICA are particularly aware of emerging technologies and the requirements of the diagnostic market, and are continuously investing in our research and development department, which is involved in advanced molecular biology diagnostics in microbiology, virology, oncology, and genetics. Our main competences cover diagnostics based on qualitative and quantitative determination of nucleic acids by molecular biology methods, the development and implementation of biobanking management systems as well as in vivo and in vitro diagnostics using breath test and stable isotopes.

AB ANALITICA has a sales agent network that covers the entire Italian territory and we collaborate with local distributors in many export countries.

AB ANALITICA is certified according to UNI EN ISO 9001 and UNI EN ISO 13485 for the design, development, production and trade of in-vitro diagnostic medical devices (IVD) in the fields of infectious diseases, in hematology, in oncology and genetic testing, in pharmacogenetics, breath tests, Next Gene Sequencing (NGS), automated solutions for sample preparation for in-vitro diagnostics as well as technical assistance for these systems. In addition AB ANALITICA markets and provides technical assistance for instruments for in-vitro diagnostics and offers laboratory services for clinical chemistry analyses.

All our products for diagnostic use have been certified according to directive 98/79/EC on medical in-vitro diagnostic devices. Our product lines include:

HCV genotyping kits (Hepatitis C Virus), conforming to Annex II, list A, of directive 98/79/EC
End-Point PCR and Real-Time PCR kits for detection of infection markers of Chlamydia trachomatis and Cytomegalovirus, conforming to Annex II, list B, of directive 98/79/EC
PCR kits for determination of genetic predisposition based on HLA typing, conforming to Annex II, list B, of directive 98/79/EC

We at AB ANALITICA ensure both efficacy and optimal performance of our devices using Internal Controls and by regularly participating in External Quality Assessment programs.

AB ANALITICA is also certified by the CFDA (China Food and Drug Administration) for HPV diagnostics, has registered products as ASRs (Analyte Specific Reagents) with the FDA (U.S. Food and Drug Administration) and is authorized to export in 40 different countries.

Production
Our in vitro diagnostics (IVD) are made in our Padua branch. Over 2400 sqm of laboratories are reserved for Production and R&D. The entire production cycle is subject to strict quality controls.

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