Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection

Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the...
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Autor*in:	Liu, Weiwei [verfasserIn] Hu, Tingting Chen, Yuming Zhang, Xinju Gu, Xiaoye Guan, Ming

Format:	E-Artikel
Sprache:	Englisch

Erschienen:	2014

Schlagwörter:	Polycythemia Vera Essential Thrombocythemia JAK2 V617F JAK2 V617F Mutation Target Template

Anmerkung:	© Springer International Publishing Switzerland 2014

Übergeordnetes Werk:	Enthalten in: Molecular diagnosis & therapy - [S.l.] : Springer International, 2006, 18(2014), 5 vom: 12. Juli, Seite 579-585
Übergeordnetes Werk:	volume:18 ; year:2014 ; number:5 ; day:12 ; month:07 ; pages:579-585

Links:	Volltext

DOI / URN:	10.1007/s40291-014-0111-6

Katalog-ID:	SPR036611158

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100	1		\|a Liu, Weiwei \|e verfasserin \|4 aut
245	1	0	\|a Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection
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520			\|a Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation.
650		4	\|a Polycythemia Vera \|7 (dpeaa)DE-He213
650		4	\|a Essential Thrombocythemia \|7 (dpeaa)DE-He213
650		4	\|a JAK2 V617F \|7 (dpeaa)DE-He213
650		4	\|a JAK2 V617F Mutation \|7 (dpeaa)DE-He213
650		4	\|a Target Template \|7 (dpeaa)DE-He213
700	1		\|a Hu, Tingting \|4 aut
700	1		\|a Chen, Yuming \|4 aut
700	1		\|a Zhang, Xinju \|4 aut
700	1		\|a Gu, Xiaoye \|4 aut
700	1		\|a Guan, Ming \|4 aut
773	0	8	\|i Enthalten in \|t Molecular diagnosis & therapy \|d [S.l.] : Springer International, 2006 \|g 18(2014), 5 vom: 12. Juli, Seite 579-585 \|w (DE-627)51122799X \|w (DE-600)2232973-0 \|x 1179-2000 \|7 nnns
773	1	8	\|g volume:18 \|g year:2014 \|g number:5 \|g day:12 \|g month:07 \|g pages:579-585
856	4	0	\|u https://dx.doi.org/10.1007/s40291-014-0111-6 \|z lizenzpflichtig \|3 Volltext
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912			\|a GBV_ILN_23
912			\|a GBV_ILN_24
912			\|a GBV_ILN_31
912			\|a GBV_ILN_32
912			\|a GBV_ILN_39
912			\|a GBV_ILN_40
912			\|a GBV_ILN_60
912			\|a GBV_ILN_62
912			\|a GBV_ILN_63
912			\|a GBV_ILN_65
912			\|a GBV_ILN_69
912			\|a GBV_ILN_70
912			\|a GBV_ILN_73
912			\|a GBV_ILN_74
912			\|a GBV_ILN_90
912			\|a GBV_ILN_95
912			\|a GBV_ILN_100
912			\|a GBV_ILN_101
912			\|a GBV_ILN_105
912			\|a GBV_ILN_110
912			\|a GBV_ILN_120
912			\|a GBV_ILN_138
912			\|a GBV_ILN_150
912			\|a GBV_ILN_151
912			\|a GBV_ILN_161
912			\|a GBV_ILN_170
912			\|a GBV_ILN_171
912			\|a GBV_ILN_187
912			\|a GBV_ILN_213
912			\|a GBV_ILN_224
912			\|a GBV_ILN_230
912			\|a GBV_ILN_250
912			\|a GBV_ILN_266
912			\|a GBV_ILN_281
912			\|a GBV_ILN_285
912			\|a GBV_ILN_293
912			\|a GBV_ILN_370
912			\|a GBV_ILN_602
912			\|a GBV_ILN_636
912			\|a GBV_ILN_702
912			\|a GBV_ILN_2001
912			\|a GBV_ILN_2003
912			\|a GBV_ILN_2004
912			\|a GBV_ILN_2005
912			\|a GBV_ILN_2006
912			\|a GBV_ILN_2007
912			\|a GBV_ILN_2008
912			\|a GBV_ILN_2009
912			\|a GBV_ILN_2010
912			\|a GBV_ILN_2011
912			\|a GBV_ILN_2014
912			\|a GBV_ILN_2015
912			\|a GBV_ILN_2020
912			\|a GBV_ILN_2021
912			\|a GBV_ILN_2025
912			\|a GBV_ILN_2026
912			\|a GBV_ILN_2027
912			\|a GBV_ILN_2031
912			\|a GBV_ILN_2034
912			\|a GBV_ILN_2037
912			\|a GBV_ILN_2038
912			\|a GBV_ILN_2039
912			\|a GBV_ILN_2044
912			\|a GBV_ILN_2048
912			\|a GBV_ILN_2049
912			\|a GBV_ILN_2050
912			\|a GBV_ILN_2055
912			\|a GBV_ILN_2057
912			\|a GBV_ILN_2059
912			\|a GBV_ILN_2061
912			\|a GBV_ILN_2064
912			\|a GBV_ILN_2065
912			\|a GBV_ILN_2068
912			\|a GBV_ILN_2088
912			\|a GBV_ILN_2093
912			\|a GBV_ILN_2106
912			\|a GBV_ILN_2107
912			\|a GBV_ILN_2108
912			\|a GBV_ILN_2110
912			\|a GBV_ILN_2111
912			\|a GBV_ILN_2112
912			\|a GBV_ILN_2113
912			\|a GBV_ILN_2118
912			\|a GBV_ILN_2129
912			\|a GBV_ILN_2143
912			\|a GBV_ILN_2144
912			\|a GBV_ILN_2147
912			\|a GBV_ILN_2148
912			\|a GBV_ILN_2152
912			\|a GBV_ILN_2153
912			\|a GBV_ILN_2188
912			\|a GBV_ILN_2190
912			\|a GBV_ILN_2232
912			\|a GBV_ILN_2336
912			\|a GBV_ILN_2446
912			\|a GBV_ILN_2470
912			\|a GBV_ILN_2507
912			\|a GBV_ILN_2522
912			\|a GBV_ILN_2548
912			\|a GBV_ILN_4035
912			\|a GBV_ILN_4037
912			\|a GBV_ILN_4046
912			\|a GBV_ILN_4112
912			\|a GBV_ILN_4125
912			\|a GBV_ILN_4242
912			\|a GBV_ILN_4246
912			\|a GBV_ILN_4249
912			\|a GBV_ILN_4251
912			\|a GBV_ILN_4305
912			\|a GBV_ILN_4306
912			\|a GBV_ILN_4307
912			\|a GBV_ILN_4313
912			\|a GBV_ILN_4322
912			\|a GBV_ILN_4323
912			\|a GBV_ILN_4324
912			\|a GBV_ILN_4325
912			\|a GBV_ILN_4326
912			\|a GBV_ILN_4333
912			\|a GBV_ILN_4334
912			\|a GBV_ILN_4335
912			\|a GBV_ILN_4336
912			\|a GBV_ILN_4338
912			\|a GBV_ILN_4393
912			\|a GBV_ILN_4700
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allfields	10.1007/s40291-014-0111-6 doi (DE-627)SPR036611158 (SPR)s40291-014-0111-6-e DE-627 ger DE-627 rakwb eng Liu, Weiwei verfasserin aut Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation. Polycythemia Vera (dpeaa)DE-He213 Essential Thrombocythemia (dpeaa)DE-He213 JAK2 V617F (dpeaa)DE-He213 JAK2 V617F Mutation (dpeaa)DE-He213 Target Template (dpeaa)DE-He213 Hu, Tingting aut Chen, Yuming aut Zhang, Xinju aut Gu, Xiaoye aut Guan, Ming aut Enthalten in Molecular diagnosis & therapy [S.l.] : Springer International, 2006 18(2014), 5 vom: 12. Juli, Seite 579-585 (DE-627)51122799X (DE-600)2232973-0 1179-2000 nnns volume:18 year:2014 number:5 day:12 month:07 pages:579-585 https://dx.doi.org/10.1007/s40291-014-0111-6 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2014 5 12 07 579-585
spelling	10.1007/s40291-014-0111-6 doi (DE-627)SPR036611158 (SPR)s40291-014-0111-6-e DE-627 ger DE-627 rakwb eng Liu, Weiwei verfasserin aut Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation. Polycythemia Vera (dpeaa)DE-He213 Essential Thrombocythemia (dpeaa)DE-He213 JAK2 V617F (dpeaa)DE-He213 JAK2 V617F Mutation (dpeaa)DE-He213 Target Template (dpeaa)DE-He213 Hu, Tingting aut Chen, Yuming aut Zhang, Xinju aut Gu, Xiaoye aut Guan, Ming aut Enthalten in Molecular diagnosis & therapy [S.l.] : Springer International, 2006 18(2014), 5 vom: 12. Juli, Seite 579-585 (DE-627)51122799X (DE-600)2232973-0 1179-2000 nnns volume:18 year:2014 number:5 day:12 month:07 pages:579-585 https://dx.doi.org/10.1007/s40291-014-0111-6 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2014 5 12 07 579-585
allfields_unstemmed	10.1007/s40291-014-0111-6 doi (DE-627)SPR036611158 (SPR)s40291-014-0111-6-e DE-627 ger DE-627 rakwb eng Liu, Weiwei verfasserin aut Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation. Polycythemia Vera (dpeaa)DE-He213 Essential Thrombocythemia (dpeaa)DE-He213 JAK2 V617F (dpeaa)DE-He213 JAK2 V617F Mutation (dpeaa)DE-He213 Target Template (dpeaa)DE-He213 Hu, Tingting aut Chen, Yuming aut Zhang, Xinju aut Gu, Xiaoye aut Guan, Ming aut Enthalten in Molecular diagnosis & therapy [S.l.] : Springer International, 2006 18(2014), 5 vom: 12. Juli, Seite 579-585 (DE-627)51122799X (DE-600)2232973-0 1179-2000 nnns volume:18 year:2014 number:5 day:12 month:07 pages:579-585 https://dx.doi.org/10.1007/s40291-014-0111-6 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2014 5 12 07 579-585
allfieldsGer	10.1007/s40291-014-0111-6 doi (DE-627)SPR036611158 (SPR)s40291-014-0111-6-e DE-627 ger DE-627 rakwb eng Liu, Weiwei verfasserin aut Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation. Polycythemia Vera (dpeaa)DE-He213 Essential Thrombocythemia (dpeaa)DE-He213 JAK2 V617F (dpeaa)DE-He213 JAK2 V617F Mutation (dpeaa)DE-He213 Target Template (dpeaa)DE-He213 Hu, Tingting aut Chen, Yuming aut Zhang, Xinju aut Gu, Xiaoye aut Guan, Ming aut Enthalten in Molecular diagnosis & therapy [S.l.] : Springer International, 2006 18(2014), 5 vom: 12. Juli, Seite 579-585 (DE-627)51122799X (DE-600)2232973-0 1179-2000 nnns volume:18 year:2014 number:5 day:12 month:07 pages:579-585 https://dx.doi.org/10.1007/s40291-014-0111-6 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2014 5 12 07 579-585
allfieldsSound	10.1007/s40291-014-0111-6 doi (DE-627)SPR036611158 (SPR)s40291-014-0111-6-e DE-627 ger DE-627 rakwb eng Liu, Weiwei verfasserin aut Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection 2014 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier © Springer International Publishing Switzerland 2014 Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation. Polycythemia Vera (dpeaa)DE-He213 Essential Thrombocythemia (dpeaa)DE-He213 JAK2 V617F (dpeaa)DE-He213 JAK2 V617F Mutation (dpeaa)DE-He213 Target Template (dpeaa)DE-He213 Hu, Tingting aut Chen, Yuming aut Zhang, Xinju aut Gu, Xiaoye aut Guan, Ming aut Enthalten in Molecular diagnosis & therapy [S.l.] : Springer International, 2006 18(2014), 5 vom: 12. Juli, Seite 579-585 (DE-627)51122799X (DE-600)2232973-0 1179-2000 nnns volume:18 year:2014 number:5 day:12 month:07 pages:579-585 https://dx.doi.org/10.1007/s40291-014-0111-6 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_11 GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_63 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_101 GBV_ILN_105 GBV_ILN_110 GBV_ILN_120 GBV_ILN_138 GBV_ILN_150 GBV_ILN_151 GBV_ILN_161 GBV_ILN_170 GBV_ILN_171 GBV_ILN_187 GBV_ILN_213 GBV_ILN_224 GBV_ILN_230 GBV_ILN_250 GBV_ILN_266 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_636 GBV_ILN_702 GBV_ILN_2001 GBV_ILN_2003 GBV_ILN_2004 GBV_ILN_2005 GBV_ILN_2006 GBV_ILN_2007 GBV_ILN_2008 GBV_ILN_2009 GBV_ILN_2010 GBV_ILN_2011 GBV_ILN_2014 GBV_ILN_2015 GBV_ILN_2020 GBV_ILN_2021 GBV_ILN_2025 GBV_ILN_2026 GBV_ILN_2027 GBV_ILN_2031 GBV_ILN_2034 GBV_ILN_2037 GBV_ILN_2038 GBV_ILN_2039 GBV_ILN_2044 GBV_ILN_2048 GBV_ILN_2049 GBV_ILN_2050 GBV_ILN_2055 GBV_ILN_2057 GBV_ILN_2059 GBV_ILN_2061 GBV_ILN_2064 GBV_ILN_2065 GBV_ILN_2068 GBV_ILN_2088 GBV_ILN_2093 GBV_ILN_2106 GBV_ILN_2107 GBV_ILN_2108 GBV_ILN_2110 GBV_ILN_2111 GBV_ILN_2112 GBV_ILN_2113 GBV_ILN_2118 GBV_ILN_2129 GBV_ILN_2143 GBV_ILN_2144 GBV_ILN_2147 GBV_ILN_2148 GBV_ILN_2152 GBV_ILN_2153 GBV_ILN_2188 GBV_ILN_2190 GBV_ILN_2232 GBV_ILN_2336 GBV_ILN_2446 GBV_ILN_2470 GBV_ILN_2507 GBV_ILN_2522 GBV_ILN_2548 GBV_ILN_4035 GBV_ILN_4037 GBV_ILN_4046 GBV_ILN_4112 GBV_ILN_4125 GBV_ILN_4242 GBV_ILN_4246 GBV_ILN_4249 GBV_ILN_4251 GBV_ILN_4305 GBV_ILN_4306 GBV_ILN_4307 GBV_ILN_4313 GBV_ILN_4322 GBV_ILN_4323 GBV_ILN_4324 GBV_ILN_4325 GBV_ILN_4326 GBV_ILN_4333 GBV_ILN_4334 GBV_ILN_4335 GBV_ILN_4336 GBV_ILN_4338 GBV_ILN_4393 GBV_ILN_4700 AR 18 2014 5 12 07 579-585
language	English
source	Enthalten in Molecular diagnosis & therapy 18(2014), 5 vom: 12. Juli, Seite 579-585 volume:18 year:2014 number:5 day:12 month:07 pages:579-585
sourceStr	Enthalten in Molecular diagnosis & therapy 18(2014), 5 vom: 12. Juli, Seite 579-585 volume:18 year:2014 number:5 day:12 month:07 pages:579-585
format_phy_str_mv	Article
institution	findex.gbv.de
topic_facet	Polycythemia Vera Essential Thrombocythemia JAK2 V617F JAK2 V617F Mutation Target Template
isfreeaccess_bool	false
container_title	Molecular diagnosis & therapy
authorswithroles_txt_mv	Liu, Weiwei @@aut@@ Hu, Tingting @@aut@@ Chen, Yuming @@aut@@ Zhang, Xinju @@aut@@ Gu, Xiaoye @@aut@@ Guan, Ming @@aut@@
publishDateDaySort_date	2014-07-12T00:00:00Z
hierarchy_top_id	51122799X
id	SPR036611158
language_de	englisch
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author	Liu, Weiwei
spellingShingle	Liu, Weiwei misc Polycythemia Vera misc Essential Thrombocythemia misc JAK2 V617F misc JAK2 V617F Mutation misc Target Template Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection
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topic_title	Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection Polycythemia Vera (dpeaa)DE-He213 Essential Thrombocythemia (dpeaa)DE-He213 JAK2 V617F (dpeaa)DE-He213 JAK2 V617F Mutation (dpeaa)DE-He213 Target Template (dpeaa)DE-He213
topic	misc Polycythemia Vera misc Essential Thrombocythemia misc JAK2 V617F misc JAK2 V617F Mutation misc Target Template
topic_unstemmed	misc Polycythemia Vera misc Essential Thrombocythemia misc JAK2 V617F misc JAK2 V617F Mutation misc Target Template
topic_browse	misc Polycythemia Vera misc Essential Thrombocythemia misc JAK2 V617F misc JAK2 V617F Mutation misc Target Template
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title	Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection
ctrlnum	(DE-627)SPR036611158 (SPR)s40291-014-0111-6-e
title_full	Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection
author_sort	Liu, Weiwei
journal	Molecular diagnosis & therapy
journalStr	Molecular diagnosis & therapy
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author_browse	Liu, Weiwei Hu, Tingting Chen, Yuming Zhang, Xinju Gu, Xiaoye Guan, Ming
container_volume	18
format_se	Elektronische Aufsätze
author-letter	Liu, Weiwei
doi_str_mv	10.1007/s40291-014-0111-6
title_sort	development and validation of a tetra-primer amplification refractory mutation system-polymerase chain reaction combined with melting analysis-assay for clinical jak2 v617f mutation detection
title_auth	Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection
abstract	Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation. © Springer International Publishing Switzerland 2014
abstractGer	Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation. © Springer International Publishing Switzerland 2014
abstract_unstemmed	Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation. © Springer International Publishing Switzerland 2014
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title_short	Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection
url	https://dx.doi.org/10.1007/s40291-014-0111-6
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author2	Hu, Tingting Chen, Yuming Zhang, Xinju Gu, Xiaoye Guan, Ming
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doi_str	10.1007/s40291-014-0111-6
up_date	2024-07-03T18:39:44.400Z
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fullrecord_marcxml	<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR036611158</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230520005549.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201007s2014 xx \|\|\|\|\|o 00\| \|\|eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s40291-014-0111-6</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR036611158</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s40291-014-0111-6-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Liu, Weiwei</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2014</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="500" ind1=" " ind2=" "><subfield code="a">© Springer International Publishing Switzerland 2014</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Background and objective JAK2 V617F mutation is a molecular marker for myeloproliferative neoplasms (MPNs). As there are no China Food and Drug Administration-approved assays for the detection of JAK2 V617F mutation in China, validation of the analytic performance of this assay is important for the clinical laboratory before its clinical implementation. We have established a method for detecting JAK2 V617F using tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis. Methods A total of 202 blood samples and 20 bone marrow aspirates were obtained from MPNs patients at Huashan Hospital, Fudan University. The accuracy, precision, reproducibility, analytical sensitivity, lower limit of detection, analytical specificity, interfering substances, ruggedness, robustness, reportable range and reporting of this assay were validated. Results There was a close agreement between the reference method (sequencing) and melting-curve analysis (κ = 0.89). The precision was 100 % and the results of the assay were unaffected by lipoprotein (<27 mmol/L) or bilirubin (<450 µmol/L). The analytical sensitivity of the JAK2 mutation was 1.25 %. Conclusions Tetra-primer amplification refractory mutation system-polymerase chain reaction (tetra-primer ARMS-PCR) combined with melting-curve analysis can be used in the clinical laboratory for detection of the JAK2 V617F mutation.</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Polycythemia Vera</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Essential Thrombocythemia</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">JAK2 V617F</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">JAK2 V617F Mutation</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="650" ind1=" " ind2="4"><subfield code="a">Target Template</subfield><subfield code="7">(dpeaa)DE-He213</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Hu, Tingting</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Chen, Yuming</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Zhang, Xinju</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Gu, Xiaoye</subfield><subfield code="4">aut</subfield></datafield><datafield tag="700" ind1="1" ind2=" "><subfield code="a">Guan, Ming</subfield><subfield code="4">aut</subfield></datafield><datafield tag="773" ind1="0" ind2="8"><subfield code="i">Enthalten in</subfield><subfield code="t">Molecular diagnosis & therapy</subfield><subfield code="d">[S.l.] : Springer International, 2006</subfield><subfield code="g">18(2014), 5 vom: 12. 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Development and Validation of a Tetra-Primer Amplification Refractory Mutation System-Polymerase Chain Reaction Combined with Melting Analysis-Assay for Clinical JAK2 V617F Mutation Detection

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