Abstract: The invention concerns soluble and antigenic HTLV p24 variants that can be fused to chaperones and their use in diagnostic applications such as immunoassays for detecting antibodies against HTLV-I or HTLV-II in an isolated biological sample. In particular, the invention relates to a soluble HTLV-I or HTLV-II p24 antigen comprising either the N- or the C-terminal domain of p24 and lacking the other domain. Moreover, the invention covers recombinant DNA molecules encoding these HTLV-I and -II fusion antigens as well as their recombinant production using expression vectors and host cells transformed with such expression vectors. In addition, the invention focuses on compositions of these HTLV p24 antigens with HTLV gp21 antigen and on an immunoassay method for detection of HTLV antibodies using the antigens of the invention. Also the use of HTLV p24 antigens in an in vitro diagnostic assay as well as a reagent kit for detection of anti-HTLV-antibodies comprising said HTLV antigens is encompassed.

Abstract: The present invention concerns an in vitro method for measurement of 25-hydroxyvitamin D, wherein the potentially interfering compound 24,25-dihydroxyvitamin D3 is blocked by a binding agent specifically binding to 24,25-dihydroxyvitamin D3 and not binding to 25-hydroxyvitamin D.

Abstract: The disclosure relates to a polypeptide suitable for detecting antibodies against a flavivirus in an isolated biological sample having a flavivirus NS1 wing domain specific amino acid sequence, wherein no amino acid sequences from the NS1 ?-ladder domain of said flavivirus are present in the polypeptide. In an embodiment, the flavivirus is selected from Zika virus (ZIKV), West-Nile virus (WNV), Dengue virus types 1-4 (DENV1-4), tick-borne encephalitis virus (TBEV), yellow fever virus (YFV) and Japanese encephalitis virus (JEV). Also disclosed is a method for producing said flaviviral NS1 wing domain specific polypeptides, a method for detecting antibodies specific for a first flavivirus species, the use of said flaviviral NS1 wing domain specific polypeptides for detecting antibodies as well as a reagent kit for detecting said flavivirus antibodies that has a flavivirus NS1 wing domain polypeptide.

Abstract: The disclosure relates to a polypeptide suitable for detecting antibodies against a flavivirus in an isolated biological sample having a flavivirus NS1 wing domain specific amino acid sequence, wherein no amino acid sequences from the NS1 ß-ladder domain of said flavivirus are present in the polypeptide. In an embodiment, the flavivirus is selected from Zika virus (ZIKV), West-Nile virus (WNV), Dengue virus types 1-4 (DENV1-4), tick-borne encephalitis virus (TBEV), yellow fever virus (YFV) and Japanese encephalitis virus (JEV). Also disclosed is a method for producing said flaviviral NS1 wing domain specific polypeptides, a method for detecting antibodies specific for a first flavivirus species, the use of said flaviviral NS1 wing domain specific polypeptides for detecting antibodies as well as a reagent kit for detecting said flavivirus antibodies that has a flavivirus NS1 wing domain polypeptide.

Abstract: The disclosure concerns a polypeptide suitable for detecting antibodies against Zika virus in an isolated biological sample having a Zika virus NS1 wing domain specific amino acid sequence and variants thereof, wherein no further Zika virus specific amino acid sequences are present in the polypeptide. This polypeptide does not immunologically cross-react with antibodies raised against structurally related antigens from tick-borne encephalitis virus, Dengue virus 1-4, West Nile virus, yellow fever virus or Japanese encephalitis virus, but immunologically reacts with antibodies raised against full length Zika virus NS1 antigen. Also disclosed is a method of producing a soluble and immunoreactive Zika virus NS1 polypeptide as well as methods and kits for detecting antibodies specific for Zika virus in an isolated sample.

Abstract: In conventional automatic analyzers, there have been instances where, when a plurality of associated items are analyzed as a set item, there is high variation in the analysis data obtained using the set item, leading to a need for improvement of analysis precision. The present invention comprises performing, in mutual association, a set of preparation steps to carry out until it is time to analyze an unknown sample, the set of preparation steps including a pre-preparation step in which stirring, etc., is performed when an analysis reagent kit is mounted on the analyzer, and a step for correcting a standard curve in which correction samples that correspond to analysis items are used. This makes it possible to perform analysis after the preparation states of a plurality of analysis reagent kits are collected as needed, enabling high-precision analysis of a set item.

Abstract: The disclosure concerns a polypeptide suitable for detecting antibodies against Zika virus in an isolated biological sample having a Zika virus NS1 wing domain specific amino acid sequence and variants thereof, wherein no further Zika virus specific amino acid sequences are present in the polypeptide. This polypeptide does not immunologically cross-react with antibodies raised against structurally related antigens from tick-borne encephalitis virus, Dengue virus 1-4, West Nile virus, yellow fever virus or Japanese encephalitis virus, but immunologically reacts with antibodies raised against full length Zika virus NS1 antigen. Also disclosed is a method of producing a soluble and immunoreactive Zika virus NS1 polypeptide as well as methods and kits for detecting antibodies specific for Zika virus in an isolated sample.

Abstract: The disclosure relates to a polypeptide suitable for detecting antibodies against a flavivirus in an isolated biological sample having a flavivirus NS1 wing domain specific amino acid sequence, wherein no amino acid sequences from the NS1 ß-ladder domain of said flavivirus are present in the polypeptide. In an embodiment, the flavivirus is selected from Zika virus (ZIKV), West-Nile virus (WNV), Dengue virus types 1-4 (DENV1-4), tick-borne encephalitis virus (TBEV), yellow fever virus (YFV) and Japanese encephalitis virus (JEV). Also disclosed is a method for producing said flaviviral NS1 wing domain specific polypeptides, a method for detecting antibodies specific for a first flavivirus species, the use of said flaviviral NS1 wing domain specific polypeptides for detecting antibodies as well as a reagent kit for detecting said flavivirus antibodies that has a flavivirus NS1 wing domain polypeptide.

Abstract: The invention concerns soluble and antigenic HTLV p24 variants that can be fused to chaperones and their use in diagnostic applications such as immunoassays for detecting antibodies against HTLV-I or HTLV-II in an isolated biological sample. In particular, the invention relates to a soluble HTLV-I or HTLV-II p24 antigen comprising either the N- or the C-terminal domain of p24 and lacking the other domain. Moreover, the invention covers recombinant DNA molecules encoding these HTLV-I and -II fusion antigens as well as their recombinant production using expression vectors and host cells transformed with such expression vectors. In addition, the invention focuses on compositions of these HTLV p24 antigens with HTLV gp21 antigen and on an immunoassay method for detection of HTLV antibodies using the antigens of the invention. Also the use of HTLV p24 antigens in an in vitro diagnostic assay as well as a reagent kit for detection of anti-HTLV-antibodies comprising said HTLV antigens is encompassed.

Abstract: The invention concerns soluble and antigenic HTLV p24 variants that can be fused to chaperones and their use in diagnostic applications such as immunoassays for detecting antibodies against HTLV-I or HTLV-II in an isolated biological sample. In particular, the invention relates to a soluble HTLV-I or HTLV-II p24 antigen comprising either the N- or the C-terminal domain of p24 and lacking the other domain. Moreover, the invention covers recombinant DNA molecules encoding these HTLV-I and -II fusion antigens as well as their recombinant production using expression vectors and host cells transformed with such expression vectors. In addition, the invention focuses on compositions of these HTLV p24 antigens with HTLV gp21 antigen and on an immunoassay method for detection of HTLV antibodies using the antigens of the invention. Also the use of HTLV p24 antigens in an in vitro diagnostic assay as well as a reagent kit for detection of anti-HTLV-antibodies comprising said HTLV antigens is encompassed.

Abstract: A test management system is presented. The system comprises an analyzer to perform tests a sample according to a first set of instructions, a manager module connected to the analyzer, and a first order interface connected to the manager module. The manager module directs activity of the analyzer according to a second set of instructions. The first order interface receives an order for a first analytical test and a second analytical test and transmits the order to the manager module. If the order is for the first analytical test, the test manager module forwards the order directly to the analyzer and the sample is analyzed by the analyzer according to the first set of instructions. If the order is for the second analytical test, the manager module handles the order according to the second set of instructions and generates and transmits secondary test requests to the analyzer.

Abstract: In conventional automatic analyzers, there have been instances where, when a plurality of associated items are analyzed as a set item, there is high variation in the analysis data obtained using the set item, leading to a need for improvement of analysis precision. The present invention comprises performing, in mutual association, a set of preparation steps to carry out until it is time to analyze an unknown sample, the set of preparation steps including a pre-preparation step in which stirring, etc., is performed when an analysis reagent kit is mounted on the analyzer, and a step for correcting a standard curve in which correction samples that correspond to analysis items are used. This makes it possible to perform analysis after the preparation states of a plurality of analysis reagent kits are collected as needed, enabling high-precision analysis of a set item.

Abstract: Disclosed is a method for detecting a capsid polypeptide of a non-enveloped virus in a sample from a subject which includes (a) contacting the sample with a base, and (b) detecting a capsid polypeptide of the virus in the sample. Moreover, the present disclosure relates to a method for pre-processing a sample from a subject for detection of a virus, including contacting the sample with a base. Moreover, the present disclosure relates to kits, uses and devices related to these methods.

Abstract: The present invention concerns an in vitro method for measurement of 25-hydroxyvitamin D, wherein the potentially interfering compound 24,25-dihydroxyvitamin D3 is blocked by a binding agent specifically binding to 24,25-dihydroxyvitamin D3 and not binding to 25-hydroxyvitamin D.

Abstract: The invention relates to a method for detecting antibodies against the TpN17 antigen of Treponema pallidum in an isolated sample wherein a peptide sequence of Vibrio cholerae lipoprotein 15 (VcLp15) or a partial sequence thereof is used as a reagent for reduction of interference, i.e. for minimizing false positive results. In addition the invention relates to fusion polypeptides comprising a VcLp15 peptide sequence and a chaperone, to their use as an additive in an immunoassay for said reduction of interferences and for minimizing false positive results and to a reagent kit for detecting antibodies against Treponema pallidum antigens in an isolated sample comprising a TpN17 antigen and said VcLp15-chaperone fusion polypeptide.

Abstract: The invention concerns soluble and antigenic HTLV p24 variants that can be fused to chaperones and their use in diagnostic applications such as immunoassays for detecting antibodies against HTLV-I or HTLV-II in an isolated biological sample. In particular, the invention relates to a soluble HTLV-I or HTLV-II p24 antigen comprising either the N- or the C-terminal domain of p24 and lacking the other domain. Moreover, the invention covers recombinant DNA molecules encoding these HTLV-I and -II fusion antigens as well as their recombinant production using expression vectors and host cells transformed with such expression vectors. In addition, the invention focuses on compositions of these HTLV p24 antigens with HTLV gp21 antigen and on an immunoassay method for detection of HTLV antibodies using the antigens of the invention. Also the use of HTLV p24 antigens in an in vitro diagnostic assay as well as a reagent kit for detection of anti-HTLV-antibodies comprising said HTLV antigens is encompassed.

Abstract: A test management system is presented. The system comprises an analyzer to perform tests a sample according to a first set of instructions, a manager module connected to the analyzer, and a first order interface connected to the manager module. The manager module directs activity of the analyzer according to a second set of instructions. The first order interface receives an order for a first analytical test and a second analytical test and transmits the order to the manager module. If the order is for the first analytical test, the test manager module forwards the order directly to the analyzer and the sample is analyzed by the analyzer according to the first set of instructions. If the order is for the second analytical test, the manager module handles the order according to the second set of instructions and generates and transmits secondary test requests to the analyzer.

Abstract: The invention concerns soluble variants of Treponema pallidum antigen 47 (TpN47 antigen) comprising at least domain B, or at least domains A and B, optionally domain D of the complete TpN47 protein molecule with the proviso that all antigens lack domain C (amino acid residues 224 to 351) of TpN47. The Tpn47 antigens can be fused to a chaperone. Moreover, the invention covers DNA encoding the antigens, a method of producing these antigens as well as the use of these antigens in an immunodiagnostic assay for the detection of antibodies against Treponema pallidum in an isolated sample.

Abstract: The present invention relates to fusion proteins suitable as test antigens in the detection of infections with pathogens, particularly of primary infections with pathogens. Further, the invention relates to methods for detecting and differentially determining antibodies, particularly IgM antibodies resulting from an infection with a pathogenic organism. Furthermore, test reagents for carrying out these methods are provided.

Abstract: The invention relates to a method for detecting antibodies against the TpN17 antigen of Treponema pallidum in an isolated sample wherein a peptide sequence of Vibrio cholerae lipoprotein 15 (VcLp15) or a partial sequence thereof is used as a reagent for reduction of interference, i.e. for minimizing false positive results. In addition the invention relates to fusion polypeptides comprising a VcLp15 peptide sequence and a chaperone, to their use as an additive in an immunoassay for said reduction of interferences and for minimizing false positive results and to a reagent kit for detecting antibodies against Treponema pallidum antigens in an isolated sample comprising a TpN17 antigen and said VcLp15-chaperone fusion polypeptide.