Supporting Everybody‘s Health

Setting new standards in haemoglobin quantification in biological samples.

haemoquick® photometer

haemoquick® cuvettes haemoquick® controls haemodirect®

Prof. Heuck and coworkers on the AHD575 method for haemoglobin

measurement used by haemoquick® and haemodirect®:

«These properties place the AHD575 method in the first line for use as a reference and a routine method.»

Eastern Mediterranean Health Journal, 12(6), 2006: 722 - 734

Decisive advantages of Medisynthana‘s product line:

• Cyanide-free• Long shelflife (> 2 years)• Chemically defined control standard• Quick and precise method• Cost-effective (no control bloods needed)• Compliant with the European Directive for in-vitro-Diagnostics (98/79/EC).• Flexible

The determination of the haemoglobin level in blood samples is the most frequently performed laboratory test. Medisynthana‘s product line meets the needs of the practioner at the point-of-care as well as those of the laboratory assisting the doctor with his therapeutic endeavours: quick and precise haemoglobin results within a few steps at minimum costs - and at the same time beneficial in many other aspects (i.e. toxicity of reagents,...).

haemoquick® photometerLED technology based photometer for mobile and stationary use. Suitable for patient-near haemo-globin diagnostics as well as laboratory in-houseuse.

haemoquick® cuvettesPrefilled and user-ready test cuvettes.

haemoquick® controlsControl solutions for quality control.

haemodirect®Kit with conversion reagent and control solutions for quality control.

laboratories health care units

point-of-care-testingblood banks

intensive caredoctor‘s practice + +

Medisynthana‘s product line: a handful of products, dozens of applications, millions of users.

For laboratories with higher throughput or institutions with high sample quantity Medisynthana offers bulk sizes of the conversion reagent and separately available control material upon request.

Cost-effective, quick, and precise: the better choice!

The haemoquick® photometer combines latest technological developments with easy and safe handling at minimum dimensions and weight. It is based on modern LED technology which guarantees the highest possible stability of the optical unit. It can be used stationary with the provided power supply or in a mobile setting with the provided reachargeable batteries. Up to 1000 sample values including date and time of measurement can be stored in the internal buffer and retrieved upon request.

Multipurpose usability

The haemoquick® photometer uses a measuring wavelength of 574nm. Therefore, also other clinical parameters which are normally measured at wavelengths close to 574nm can been measured with the haemoquick® photometer by means of adapted calculation factors or individually generated external standard curves. Thus, the end-user can profit from the fact that he can continue using his known reagents. The following parameters, among others, can be potentially measured on the haemoquick® photometer (dependent on the used method and the used wavelength):

• Bilirubin (total and direct) • total protein • albumine • HDL cholesterol • LDL cholesterol • potassium • calcium • iron

haemoquick® photometer

Specifications:

Wavelength: 574 nmLight source: LED; LED-bandwidth: ± 2 nmDetector: Silicone photodiodeMeasuring principle: Absorption/optical density Record. range: 0-2.5 AUAccuracy: ± 0.002 AUDimensions: 163 mm x 100 mm x 60 mm (L, B, H)Weight: 250 gPower input: 100-240V AC, max. 0.2 ACuvette types: Square: 0.5 ml – 4.0 ml; 12.5 mm x 12.5 mm Round: outside diameter: 13.5 mm

The product line: a handful of products, dozens of applications, millions of users.

haemoquick® - system reagents for POCT (point-of-care-testing):

haemodirect® - the kit for laboratories

haemodirect®haemodirect® is a complete user-ready kit for the deter-mination of blood haemoglobin levels using the haemo-quick® photometer or any photometer with adjustable wavelength. The kit contains controls and conversion reagent sufficient for 800 tests.

haemoquick® cuvettes100 prefilled and user-ready rectangle styrene cuvettes for use with haemoquick® photometer. For single use. No preparation necessary. Each cuvette contains 1.5 ml conversion reagent.

haemoquick® controlsThe haemoquick® controls set consists of two controls with defined concentrations of a haemoglobin equivalent and is suitable for quality control of the haemoquick® photometer.

Quick and precise: Exact hemoglobin results within a few steps

Flexibility: a multitude of ways to collect samples - simple and secure.

� Collect sample

� Mix sample and reagent � Record and read results

Collect capillary blood samples using end-to-end capillaries

Collect capillary blood samples using blow-out capillaries

Collect capillary blood samples using a laboratory pipette

Take a sample from blood drawn with a collection system

Collect 10µl of capillary blood after puncturing the finger pad using the 10µl end-to-end capillary. Throw the filled capillary into the test cuvette.

Collect 10µl of capillary blood after puncturing the finger pad using the 10µl blow-out capillary. Blow-out the blood from the capillary into the test cuvette.

Collect 10µl of capillary blood after puncturing the finger pad using a regular laboratory pipette. Blow out the blood into the test cuvette.

Pipette 10µl of the blood which has been drawn by a normal blood with-drawal device or a syringe into a test cuvette.

Mix sample and reagent by swirling gently. The conversion reagent in the test tube forms a coloured complex with haemoglobin and its variants within a few seconds. After at least 1 minute the sample can be measured. Since the formed complex is stable for at least 24 hours, test cuvettes can be kept for analysis at least 24 hours.

Place the test cuvette in the photometer and measure the absorption. Read and record the result. The sample values can be stored in the buffer of the photometer and retrieved upon request.

One of the major advantages of Medisynthana‘s product line is the fle-xibility with regard to the usable sample material. Blood samples may be collected with or without an anticoagulant (EDTA, CPDA, citrate). Capillary blood (wholefull blood) must be used immediately, before it coagulates. Anticoagulated blood may be stored at room temperature (15..25°C) for 24 hours. Also with respect to the sampling device the system offers full flexibility: sampling devices for capillary blood (end-to-end capillaries, blow-out capillaries) can be used as well as regular laboratory pipettes to collect the blood. This enables the end-user to work with the collection method which is most suitable for his needs. However, Medisynthana recommends to use end-to-end capillaries for the sample collection because the handling is easy, the dosage is precise, the risk of carry-over of blood on the outside of the capillary is low, and the method is cost-effective.

Hard facts and convincing arguments

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Figure 1: Comparison of reaction kinetics of the cyanmethaemoglobin method (based on Drabkin solution) and the AHD method (on which hae-moquick® and haemodirect® are based).

Figure 2: Comparison of methods: the comparative study of haemoglobin levels in patient samples revealed an excellent correlation between results obtained using the AHD method (hae-moquick®, haemodirect®) and results obtained using the cyanmethaemoglo-bin method.

The WHO collaborative study (Prof. Heuck and coworkers):

Prof. Heuck and coworkers compared the AHD method (developed for and used by haemoquick® and haemo-direct®) to the cyanmethaemoglobin (HiCN) method which has been used so far as a reference method. In a multicentric study, involving laboratories in Cairo, Ndanda, Rabat, and Muscat, the blood haemoglobin levels of patients and of healthy volunteers were measured using both the HiCN and AHD methods. Also stud-ied were general method related characteristics such as reaction kinetics, stability of reaction products, and costs. The study revealed that the AHD method used by haemoquick® and haemodirect® is not only as precise as the HiCN method, but offers several striking advantages over that method as well. In summary, the authors conclude that, these properties put the AHD method ahead of the field as both a reference and routine method.

Measuring principle

The haemoquick® system and haemodirect® are based on the AHD method for quantifying haemoglobin. The reagent forms a coloured complex with haemoglobin and its variants, which can be detected photometrically. The colour intensity of the complex is proportional to the total haemoglobin concentration in the test sample. A 6-point calibration is used, in keeping with international guide-lines (in particular those of the US Federal Drug Administration).

Applications

haemoquick® and haemodirect® have been developed and certified for measurement of haemoglobin concentrations in blood tests as part of in vitro diagnostics. However, the product line’s properties also make it suitable for determining haemoglobin concentrations in tests on other biological fluids (urine, aspirates, effluents).

In routine medical diagnostics, for example, haemoquick® is used regularly:

• to detect anaemia or hyperglobulia• to monitor the course and response to therapy of anaemia and hyperglobulia• to screen groups at risk of iron deficiency (pregnant women, infants, blood donors, haemodialysis

patients, diabetics, sportswomen)• in point-of-care testing, on suspicion of acute bleeding and haemorrhaging• to monitor the progress of diseases caused by infections or parasites.• to determine blood loss, e.g. in the case of paramenia or on suspicion of occult bleeding.

Properties

• Measuring range: 0.5 – 30.0 g/dl (5 – 300 g/l)• Shelf-life of the reagents and calibrators: 3 year• Comparison of methods: Multicentric comparison (6 laboratories, 1107 samples) with the cyan- methaemoglobin method resulted in a correlation of r = 0.983 (y = 0,98x + 3)• The reagents can be used with the haemoquick® photometer or any photometer with adjustable wavelength

Key data

Decisive advantages

Calibration with the help of a defined chemical control standardThe defined chemical control standard puts an end to problems arising from the short shelf-life of biological controls (so called “whole blood controls“), which are essential to other methods.

Stability of the reagents and calibratorsThe substances remain stable over long periods under extreme climate conditions.

High level of accuracyDeviations from absolute value caused by serum lipids, serum proteins or corpuscles are extremely small

Linearity of measuring rangeThe linear measuring range of the AHD method enables precise and reliable estimates of haemoglobin concentrations ranging between 0.5 g/dl and 30 g/dl.

Covers all clinically relevant haemoglobin derivativesAll clinically relevant haemoglobin species including foetal haemoglobin, sulfhaemoglobin and carboxyhaemoglobin are measured.

Swift reaction timeResults available fast - this will have a particular impact on the clinically relevant carboxyhaemoglobin.

Minimal toxicity of reagents and calibratorsIn their existing concentrations all the substances used are practically non-toxic and therefore do not require special storage and disposal.

Low costThere are no added costs for biological controls (“whole blood controls“).

At Medisynthana, we are dedicated to supporting everybody‘s health. All our efforts are directed towards developing novel solutions for unmet medical needs. Our search for better ways of maintaining and restoring health results in a steady stream of pioneering therapeutic and diagnostic products and services. We also want to provide a shareholder return that reflects outstanding performance and to adequately reward those who invest ideas and work in our company.

Medisynthana delivers a unique contribution to better healthcare. We aim to reduce suffering and improve health and quality of life of people all around the world. Our vision is to develop targeted medicines and diagnostic tools that combine to offer patients, physicians and payers better, safer, more cost-effective healthcare.

We strive for a motivating environment where creativity and effectiveness are encouraged and where cut-ting-edge technologies are applied. Medisynthana believes in the necessity of excellence and innovation in developing socially and environmentally responsible business practices.

Welcome to Medisynthana, a company that is translating a great vision into reality: Supporting Everybody‘s Health.

Welcome to Medisynthana, a company that is translating a great vision into reality: Supporting Everybody‘s Health.

MISSION

THE COMPANYMedisynthana was founded in December 2004 by renowned scientists, experienced businessmen and investors with the aim to set up a company which focuses on solutions of important medical problems. Based on the scientific ideas of chief executive officer Prof. Dr. Hans-Uwe Wolf the business was primarily formed by scientists from different disciplines, among others medicine, chemistry, biology and biochemistry. Shortly thereafter, the concept of the company became attractive to businessmen and investors, which, in consequence joined the holding in 2005.

In parallel to the foundation of the Medisynthana GmbH, the first project was realized as the Medisynthana Diagnostics GmbH & Co. KG. The diagnostic division developed the meanwhile successfully launched product line consisting of the blood test for haemoglobin quantification (haemodirect, haemoquick) and the suitable photometer haemoquick.

Actually, Medisynthana forms its next divisions, dealing with the development of cytostatic drugs and of drugs for neurodegenerative diseases, such as Parkinson’s disease.

Excellence is a matter of ability and will.

Supporting Everybody‘s Health

Medisynthana Diagnostics GmbH & Co. KGSöflinger Straße 100 · 89077 Ulm · GERMANYPhone + 49 - 731 - 9 33 10 77Fax + 49 - 731 - 9 33 10 78www.medisynthana.cominfo@medisynthana.com

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