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Custom Services

BioVendor custom services enable sample measurement and obtaining reliable results even the clients who do not have access to a fully equiped laboratory or skilled personnel.

batsBioVendor Analytical Testing Service

BioVendor provides complete assay services for the detection of selected protein markers in samples of human or animal origin and offers comprehensive sample analyses for analytes measured by our assays.

9397

BioVendor provides complete assay services for the detection of selected protein markers in samples of human or animal origin.

The BioVendor Analytical Testing Service offers comprehensive sample analyses for analytes measured by our assays. BioVendor is a direct assay kit manufacturer, giving our staff a unique understanding of assay performance. Our assays are fully validated for clinical studies. We can also modify and validate our existing assays to other types of matrices (urine, breast milk, tissue biopsy extract, CSF, BALF, saliva etc.).

Advantages

  • High quality services
  • Experienced, trained staff
  • Comprehensive results
  • Customize any aspect to your specifications 

Applications

  • Clinical study
  • Pharmaceuticals
  • Medical Devices
Equipment

Equipment

BioVendor’s facility features newly constructed laboratories with state-of-the-art equipment and a flexible area for expansion. Our laboratory area is suitable for work with all biological material, including biohazardous material. Continuous temperature monitoring and recording along with warning system assure safe, damage-proof sample storage.

6689Microplate absorbance reader (Biotek)

6690Microplate chemiluminescence reader (Biotek)

6685Microplate Data Collection & Analysis Software
Gen5 (Biotek)

6687Microplate shakers with controlled
temperature (Biosan)

6688Microplate washers (TECAN Columbus)

6686Deep freezers -80° C (New Brunswick Scientific)


Workflow

Workflow

6661

Data Generation

Data Generation

BioVendor conducts all work confidentially, accurately, and in response to our clients' needs and expectations. Results are communicated on a timely basis and in an easily understood format. Custom reports developed to meet our client's needs are available in Microsoft® Excel (including *.xls *.csv *.dbt and *.dif formats) and Microsoft® Word.

Over the course of the project, we use a single lot of the assay kit and generate and store both electronic data and printouts:

  1. Measuring date, name of operator and supervisor
  2. Raw data (absorbance at 450nm), each plate (run) will contain standards, Quality Control High, Quality Control Low all in doublet and 39 (or 40) samples in doublet determinations unless otherwise specified. Typically, any samples that read high off the standard curve will be pre-diluted and retested if the assay has proven linearity of sample dilution
  3. Calculated data: corresponding standards are used for standard curve construction (using four-parameter function) and calculation of analyte concentration in samples

Reporting of Results

Analytical Report (=Validation Report)
is available for each microplate and contains intra- and inter-assay CVs for Quality Controls

Testing Service Protocol
contains the raw data (absorbance) and calculated data for Standards, Quality Controls and samples

Results Summary
contains identifiers (sample numbers) and measured values

Final Report

Pricing

Pricing

The total price consists of the price of the kit plus the price of the service 200 EUR ($250). Prices include all necessary assay reagents, sample preparation, labor, raw data generation, and final data compilation into an easy-to-interpret format. Prices may vary according to the assay performed. Additional charges may be applicable for customers that require specific validations for processes such as cross reactivity and verification of performance characteristics with samples.

Quality Assurance

Quality Assurance

The BioVendor Analytical Testing Service has developed a system of reception of materials, which excludes the risk of loss, confusion or destruction of samples.

Transport

Transport of samples is carried out through carriers, that enable monitoring of shipments. Transport of samples can be carried out in the backup mode. The same samples are transported in two successive terms, usually with a daily or weekly delays.

Receipt of delivery

Samples are received by warehouse worker and forwarded to the service manager or trained staff. Receipt of the samples is recorded in the form, that contains the following information:

  • date of delivery
  • number of samples
  • consigner (customer)

Labeling

All samples are identified by code numbers, which do not contain personal identification number, diagnosis, or other sensitive data on individual patients.

Storage

Samples are stored in dedicated deep freezer box at -70 ° C. Storage can be carried out in the backup mode. The same samples are stored in two independent deep freezer boxes.

The BioVendor’s Department of Quality Assurance ensures complete oversight of all projects. Over the course of a project, we monitor intra-assay and inter-assay performance by using Quality Control High and Quality Control Low on each plate (run). Results are presented as intra-assay and inter-assay coefficients of variation (CV) calculated according to the formula: Expected / Obtained and expressed as a %. These outputs are available in both the Analytical (Validation) and Final Report.

  • Routine internal audits and inspections
  • Data audited for integrity and reliability
  • Security measures to ensure electronic data retrieval
  • Inspections to assure compliance to protocols and laboratory SOP's
  • Access to reports limited to authorized personnel
  • Use of serum based Quality Controls (High and Low)
  • Availability of Internal Quality Controls (IQC1, IQC2, IQC3, IQC4) in case of any need for referee measurements