NeoChrom · EN-US
NeoChrom-IVD chromatograph
Medical and toxicological laboratories
Solution for medical laboratories (IVD solution NeoChrom)
Gas chromatography is used in clinical, toxicological, narcological and other specialized laboratories for qualitative and quantitative determination of substances in biological samples.
NeoChrom develops and manufactures in Ukraine gas chromatographs for such tasks, including medical products for diagnostics in vitro — NEOCHROM IVD and NEOCHROM IVD-MS. Information about them is included in the state electronic register of medical devices.
The registered purpose covers the examination of samples blood, saliva, urine, tissues and other biological materials according to the purpose of the product and the applied method.
IVD (In Vitro Diagnostic Medical Device) — a medical product intended for the study of biological samples obtained from the human body, with the aim of obtaining medically significant information. IVD can include not only reagents and test systems, but also analytical devices and complexes with a corresponding medical purpose.
NEOCHROM IVD
Gas chromatograph with gas chromatographic detectors for medical and toxicological laboratories.
Learn more → GC-MSNEOCHROM IVD-MS
Gas chromatograph with mass spectrometric detection for tasks requiring increased specificity of identification.
Learn more →NEOCHROM IVD
NEOCHROM IVD intended for qualitative and quantitative analysis of substances in biological samples by gas-liquid or gas-adsorption chromatography.
The configuration is formed according to the analytical task and can include FID and other gas chromatographic detectors, capillary or packed columns, automatic dispensers, headspace systems and specialized software.
The device is produced in automatic and semi-automatic versions.
NEOCHROM IVD-MS
NEOCHROM IVD-MS intended for qualitative and quantitative analysis by gas chromatography with mass spectrometric detection.
Unlike traditional gas chromatographic detectors, GC-MS gives information not only about the retention time of the component, but also about its mass spectrum.
In mode SCAN it is possible to obtain spectral information in a given mass range and use mass spectra libraries for identification. Mode SIM makes it possible to control selected ions and significantly increase the sensitivity and selectivity of the determination of target compounds.
NEOCHROM IVD-MS is aimed primarily at toxicological, narcological and other laboratories where reliable identification of substances, analysis of metabolites or search for unknown organic components are required.
The main tasks of the medical and toxicological laboratory
Gas chromatography is most effective for volatile and thermally stable organic compounds, as well as substances that can be converted into GC-compatible derivatives.
Alcohol and volatile toxicants
For the determination of ethanol and other volatile substances in biological fluids headspace analysis is widely used — Headspace GC.
The sample is thermostated in a sealed vial, after which the gas phase above the sample is introduced into the chromatograph. This approach reduces the ingress of non-volatile components of the biological matrix into the analytical system, simplifies automation and increases the reproducibility of sample introduction.
For the quantitative determination of ethanol, methanol, isopropanol and other volatile organic compounds, a typical configuration is Headspace GC-FID.
Narcotic, psychotropic and medicinal substances
Biological samples are a complex matrix in which starting substances, their metabolites, drugs, endogenous components, and other compounds capable of creating analytical interference can be present at the same time.
Therefore, analysis may include sample preparation, extraction, purification, derivatization if necessary, chromatographic separation, identification, and quantification.
For complex toxicological problems, one of the most universal solutions is GC-MS. The combination of retention time, characteristic ions, and mass spectrum provides significantly higher identification specificity compared to using retention time alone.
NEOCHROM IVD or NEOCHROM IVD-MS?
The configuration should be chosen based on the analytical task, the required selectivity, sensitivity and performance of the laboratory.
| Analytical application | Typical configuration |
|---|---|
| Ethanol in biological fluids | Headspace GC-FID |
| Methanol, isopropanol and other volatile substances | Headspace GC-FID |
| Quantitative analysis of known volatile organic compounds | NEOCHROM IVD |
| Methods with selective gas chromatographic detectors | NEOCHROM IVD |
| Narcotic and psychotropic substances | NEOCHROM IVD-MS |
| Medicinal substances and metabolites | NEOCHROM IVD-MS |
| Search and identification of unknown organic components | NEOCHROM IVD-MS |
| Complex toxicological studies | NEOCHROM IVD-MS |
Both series have automatic and semi-automatic versions. Automation is appropriate for large numbers of samples of the same type, while a semi-automated configuration may be more convenient for laboratories with low throughput or a large number of different techniques.
From sample to result: a comprehensive analytical system
The result of chromatographic analysis is determined not only by the characteristics of the device itself, but by the entire analytical system.
NeoChrom can configure a complete system for a specific analytical method: a gas chromatograph or GC-MS system, an autosampler or headspace sampler, detectors, columns, gas supply equipment, software, peripherals, commissioning and staff training.
The advantage of this approach is the ability to adapt the configuration not to a universal specification, but to specific analytes, matrix, concentration range and required laboratory performance.
Regulatory status and registered versions
NEOCHROM IVD and NEOCHROM IVD-MS put into circulation as medical devices for diagnosis in vitro.
In Ukraine, the requirements for such products are established Technical regulation on medical devices for in vitro diagnostics , approved by the resolution of the Cabinet of Ministers of Ukraine No. 754 dated October 2, 2013.
| Product | Instrument versions | Catalog number | Detection |
|---|---|---|---|
| NEOCHROM IVD | automatic | NEOCHROM IVD A | gas chromatographic detectors |
| NEOCHROM IVD | semi-automatic | NEOCHROM IVD | gas chromatographic detectors |
| NEOCHROM IVD-MS | automatic | NEOCHROM IVD-MS A | mass spectrometric |
| NEOCHROM IVD-MS | semi-automatic | NEOCHROM IVD-MS | mass spectrometric |
Manufacturer: NeoCHROM LLC, Ukraine.
Trademark: NEOCHROM.
Declaration of conformity:
urn:nc_DC.PW:LE.v1.070423.1.
Declaration date: 07.04.2023.
Frequently asked questions
What is an IVD chromatograph?
This is a chromatograph designed by the manufacturer for in vitro research of biological samples obtained from the human body and marketed as a medical product in accordance with established regulatory requirements.
Are NEOCHROM IVD and NEOCHROM IVD-MS medical devices?
Yes. Information on both series is included in the state electronic register of medical devices for in vitro diagnostics.
What biological materials can be studied?
The registered purpose includes, in particular, blood, saliva, urine and tissues. The specific type of sample must correspond to the applied methodology.
What chromatograph is used to determine alcohol?
For the determination of ethanol and other volatile substances in biological fluids, a typical solution is gas chromatograph with an FID and a headspace sampler.
When is GC-MS needed?
GC-MS is appropriate for tasks where increased specificity of identification is required: analysis of narcotic, psychotropic and medicinal substances, their metabolites, complex toxicological mixtures and unknown organic components.
How does GC-MS differ from a conventional gas chromatograph?
A gas chromatograph separates the components of the mixture. In GC-MS, after separation, each component is additionally characterized by mass spectrum, which significantly expands the possibilities of its identification.
NEOCHROM IVD is a Ukrainian solution for the medical laboratory
NEOCHROM IVD and NEOCHROM IVD-MS make it possible to form an analytical system for the specific tasks of a medical, toxicological or narcological laboratory — from Headspace GC-FID for the analysis of volatile substances to GC-MS for highly selective identification of organic compounds.
The configuration is selected according to the methodology, sample type, concentration range, required sensitivity and laboratory performance.