Downloads. Package insert Spanish Lot: – Expiry: 05/ Ed. 8; Package insert French Lot: – Expiry: 05/ Ed. 8; Package insert . Summary [1, 2]. Hemoglobin A1c (HbA1c) is a glycated hemoglobin which is formed by the non-enzymatic reaction of glucose with native hemoglobin. HbA1c FS*. Diagnostic reagent for quantitative in vitro determination of hemoglobin A1c (HbA1c) in whole blood on. DiaSys respons® Order Information.

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In a specific embodiment of the invention the pH-value of the solution is in the range of 4. In an embodiment the concentration of the stabiliser compound of the general formula IV is in the range of 2. In an alternative embodiment the SH group-trapping agent, for example NEM, is contained in a reagent solution which is kept separately from the reagent solution and is added, in which there is a leuco dye stabilised with thioalcohols.

Aspect 3—Stabilisation of the Leuco Dye A further object that the inventors of the present application set themselves is stabilisation of the leuco dye in the methods of determining the amount of HbA1c in a sample, in which such a leuco bba1c is used.

Search Expert Search Quick Search. In that respect the inventors of the present application have shown that SH groups which cause disturbance in the above-mentioned detection reaction must be blocked as much as possible.

Accordingly only one direct measurement after 2 to 15 minutes would also be possible.

hbba1c For that purpose inherent colouring of a reagent solution matrix of: Determining the amount of HbA1c can basically be effected by all quantification procedures, known to the man skilled in the art, for the glycated haemoglobin degradation products produced in method step blike for example by an HPLC analysis hva1c enzymatic bha1c, as was described hereinbefore. On the other hand leuco dyes have the advantage over other dyes that they usually have higher molecular absorption coefficients.

The reagent kit according to claim 11, wherein the solution R2 for stabilisation of the dye contains at least one compound of the general formula IV: In these embodiments selectively one of the reagent solutions also contains an SH group-trapping agent like for example NEM, wherein the SH group-trapping agent is contained in one of the reagent solutions in which the leuco dye is not contained.


The reduction of the pH-value into the range of 1 to 3 leads to very rapid and strong unfolding of the haemoglobin. In an diasyw of the present invention the various reagents used in HbA1c determination are brought together in the form of the following solutions which are provided in separate containers: These various haemolysis solution variations with and without additive were measured with respectively identical reagent 1 and reagent 2 on a clinical-chemical analyser Diayss reagent compositions were used as specified in 1b correspondingly modified as described in the Tables.

Kits for respons®: one HbA1c FS

Preferably the aim of the method according to the invention and the reagents according to the invention is to permit total haemoglobin determination at the same time as determining the amount of HbA1c. Ca 2 and chelator: As calcium or magnesium ions are of essential significance for the stability of the protein structure of the protease the use of an excess of chelator consequently causes destabilisation of the protease protein.

A comprehensive explicit representation of all conceivable embodiments is dispensed with here only for the sake of brevity and readability of the description. Those corresponding reagent base matrices 2 were then measured with a respectively identical haemolysis solution and identical reagents 1 on a BM c clinical-chemical analyser system.

The method gba1c to claim 1, wherein the stabiliser is used with a concentration in the range of 0. A reagent kit for use in a method of determining the amount of riasys haemoglobin HbA1c in a sample, wherein the reagent kit includes at least the following solutions in separate containers: In the embodiments which are present in the form diaays copolymers they include, besides the units with the above-specified hva1c formula IIthey include further methacrylate units which are esterified with aliphatic or aromatic residues.

In many aspects of the present invention there is no need for the protease used to lead to given degradation products.

It is further pointed out that it is self-evident to the man skilled in the art hb1c the embodiments by way hba1v example hereinafter only serve to set forth by way of example the possible embodiments of the present invention, that are set out as examples of the invention.

Aspect 2—Stabilisation of the Unfolded Hemoglobin Besides stabilisation of the protease the inventors of the present invention also set themselves the object of being able to unfold the haemoglobin contained in a sample, including HbA1c, as greatly as possible, and stabilise it in that unfolded form in order for example to permit digestion of the utmost efficiency of the haemoglobin by a protease and to put the haemoglobin into a measurable photometrically stable form.


Inter alia the following metalloproteases belong to the clan MA: The term phosphatidylcholine is used here to denote a compound of the general formula I: In an embodiment the solution contains 0.

Changing from Glucose to HbA1c for Diabetes Diagnosis

To ensure diasye that conversion does not already occur prior to implementation of the actual detection reaction it is advantageous if the doasys dye is stabilized in its colourless reduced form without the actual detection reaction being adversely influenced thereby.

In many embodiments of the invention however a protease is specifically used, whose proteolytic activity leads to the release of fructosyl valine histidine or fructosyl valine from the amino-terminal end of the beta chain of glycated haemoglobin. The haemoglobin which is unfolded in accordance with the present invention therefore remains in solution in contrast to denatured haemoglobin. A SumoBrain Solutions Company.

InnovaStar® – DiaSys Diagnostic Systems GmbH

The stabiliser used according to the invention can be a dissys chemical compound of the above-indicated kind a compound which is covered by one of formulae III or III or a mixture of two or more chemical compounds of the above-indicated kind.

In the embodiments in which haemolytically acting detergents are used they are preferably stored and used in the form of a haemolysis solution. In detail the results of the following batches are shown in FIG.

However, as was already mentioned hereinbefore, there is the risk that the haemoglobin is denatured, agglutinated and precipates, as can also be effected for example by adding trichloroacetic acid.

The results shown here impressively demonstrate the storage capability of an inactivated but structurally stabilised thermolysin in a liquid reagent matrix over various temperatures and time and the reactivatability thereof. The constantly low pH-value of diawys haemolysate in conjunction with the stabilising detergents has the result that the unfolded haemoglobin can be quickly and efficiently broken down. In most cases the sample will be a sample of fresh whole blood.