BIOCHIPS/MICROFLUIDICS

The amount of data of partially or fully sequenced genomes of the animal and plant kingdom is constantly growing offering manifold possibilities for science and medicine. For instance high-density microarrays have been utilised in basic research for expression analyses for many years. Due to the complexity of data, high costs and the lacking possibility of high sample throughput, they have not been applied to clinical diagnostics yet.

With the development of a low-density microarray, Greiner Bio-One could close the gap for the application of microarrays in clinical diagnostics: By means of the HTA™ Slide* (High-Throughput micro Arraying) up to 12 specimens can be manipulated simultaneously and are analysed for the presence of the requested markers.

Based on the biochip microarray technology, two product lines with different application fields were created: The oCheck® product line and the Inspect™product line. All test kits of both product lines are offered as ready-to-use kits and every test kit contains biochips, PCR master mix, hybridisation buffer and concentrates of the washing buffers in sufficient amounts.

oCheck® Product Line

The oCheck® product line from Greiner Bio-One has been developed specifically for the requirements of clinical diagnostics: Many specimens can be processed in a short period and examined for the presence of specific viral or bacterial species. For this purpose, DNA is extracted from a specimen and a target sequence is being amplified. The PCR product is transferred to the biochip and binds to the respective complementary sequence. After only a few washing steps and a subsequent drying of the biochip, the bound target sequence can be detected via fluorescence labelling. Here, the biochip is scanned and analysed with the Check Scanner™ and the CheckReport™ Software, respectively. Finally, the result of each specimen is generated automatically and can be provided to the physician.

All test kits of the oCheck®product line developed for an application in diagnostics are certified as in-vitro diagnostics according to the effective legal requirements (IVDD) and have been tested in clinical studies.

For each oCheck® product (PapilloCheck®, PapilloCheck® high-risk, ParoCheck®) a specimen collection kit and a DNA extraction kit is also available. For oCheck® customers with a high sample throughput, Greiner Bio-One exclusively developed the DNA extraction device CheckExtractor™ adapted to the necessities of the oCheck® product line (CE-IVD).

With another oCheck® product (CarnoCheck®) even minimal amounts of different animal species can be detected in food.


HTA™ Slide 12 with 12 wells
* The HTA™ Slide platform is covered by U.S.
Patent No. 8.007.744
Inspect™ Product Line

In addition, Greiner Bio-One develops and produces a product line for the biopharmaceutical industry: The products of the Inspect™ product line are used in the quality control process of biopharmaceutical production and thereby enable a considerably faster release of the manufactured products in comparison to established cultivation methods. The technology corresponds to the mentioned assay procedure of the oCheck® products

Quality Control

Both product lines contain comprehensive on-chip controls for every single specimen. The controls are evaluated in parallel with the analysis of the sample by means of the Check Report™ Software. Hereby, failure during the assay procedure can be recognised quickly and a transmission of false negative results can be anticipated.

General assay procedure of biochip products
1. PCR reaction: Amplification of a target sequence
2. Hybridsation: Binding of the fluorescently labelled amplification product to the complementary DNA sequence
3. Washing and drying: Removal of unbound DNA
4. Scanning and analysis: Scanning, evaluation and generation of a report using the CheckScanner™ and the corresponding
Check Report™ Software.