ADAMTS13 activity testing: evaluation of commercial platforms for diagnosis and monitoring of thrombotic thrombocytopenic purpura

Singh, Deepak; Subhan, Maryam; Groot, Rens de; Vanhoorelbeke, Karen; Zadvydaite, Almina; Dragūnaitė, Bertina; Scully, Marie

doi:10.1016/j.rpth.2023.100108

Cited by 8 publications

(10 citation statements)

References 14 publications

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“…The HemosIL ® (x) and Technofluor (y) assays correlated very well with each other (r = 0.98) with an intercept of 2.3 and a slope of 1.1 (Figure 1C). As Singh et al, 32 we observed that HemosIL ® tends to give lower results than the Technofluor assay. However, while they found several false-positive results in sepsis patients, we did not find major misclassifying discrepancies in our patients using the HemosIL ® assay.…”

Section: Discussionsupporting

confidence: 65%

“…A good technical and diagnostical performance of the HemosIL® AcuStar ADAMTS13 activity has already been demonstrated in comparison to the Technoclone Technozym ADAMTS‐13 Activity ELISA 30,31 and in‐house FRET‐VWF73 assays 23,27 . The Technoclone Technofluor ADAMTS13 Activity assay was recently validated by Singh et al 32 In the present study, we evaluated both of the fully automated assays using 49 samples and compared them with a manual FRET assay (Biomedica ACTIFLUOR ADAMTS13 Activity). All three assays determined accurately the ADAMTS13 activity of the first WHO International Standard for ADAMTS13 with a target value of 91%.…”

Section: Discussionmentioning

confidence: 90%

“…Activity assay was recently validated by Singh et al 32 In the present study, we evaluated both of the fully automated assays using 49 samples and compared them with a manual FRET assay (Biomedica ACTI-FLUOR ADAMTS13 Activity). All three assays determined accurately the ADAMTS13 activity of the first WHO International Standard for ADAMTS13 with a target value of 91%.…”

Section: Discussionmentioning

confidence: 99%

“…Fast processing times and utility in an emergency setting may now become available by the recent introduction of two fully automated and CE‐IVD labeled ADAMTS13 activity assays from the manufacturers Werfen 27 and Technoclone. The Werfen HemosIL® AcuStar ADAMTS13 Activity assay has previously been externally evaluated by several study groups 23,27–32 . By contrast, for the evaluation of the Technoclone Technofluor ADAMTS13 Activity assay only one research article 33 and one external evaluation 32 have been available to us.…”

Section: Introductionmentioning

confidence: 99%

“…The Werfen HemosIL ® AcuStar ADAMTS13 Activity assay has previously been externally evaluated by several study groups. 23,[27][28][29][30][31][32] By contrast, for the evaluation of the Technoclone Technofluor ADAMTS13 Activity assay only one research article 33 and one external evaluation 32 have been available to us. In the current study we evaluated both assays using the corresponding coagulation analysers (HemosIL AcuStar and Ceveron S100, respectively) measuring archived TTP-patient samples, recent non-TTP-patient samples and the WHO 1st International Standard for ADAMTS13, in comparison with a manual FRET assay from the company Biomedica.…”

mentioning

confidence: 99%

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Evaluation of two fully automated ADAMTS13 activity assays in comparison to manual FRET assay

Irsara

Egger

Harasser

et al. 2023

Int J Lab Hematology

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IntroductionThe objective of the present study was to evaluate and compare the validity and utility of two fully automated ADAMTS13 (a disintegrin and metalloproteinase with a thrombospondin type 1 motif, member 13) activity assays for clinical diagnostic decision‐making and to compare their performance.MethodsTwo automated ADAMTS13 activity assays (Werfen HemosIL® AcuStar ADAMTS13 Activity, Technoclone Technofluor ADAMTS13 Activity) were compared with a manual FRET assay (BioMedica ACTIFLUOR ADAMTS13 Activity). The following samples were used: 13 acute phase TTP (thrombotic thrombocytopenic purpura) samples from 11 different patients, one sample from a patient with congenital ADAMTS13 deficiency, 16 samples from control patients, three follow‐up samples from TTP patients in long‐term remission and one sample from a patient with stem cell transplantation related thrombotic microangiopathy (TMA). The WHO 1st International Standard for ADAMTS13 and several dilutions of normal plasma with ADAMTS13‐depleted normal plasma were also tested. Statistical analysis included descriptive statistics, sensitivity and specificity, Passing & Bablok regression and Bland–Altman plot.ResultsThe quantitative comparison between the HemosIL® (x) and Technofluor (y) methods showed a strong correlation (Pearson r = 0.98, n = 49). When considering an ADAMTS13 activity of <10% as a hallmark for the diagnosis of TTP, two fully automated assays were both able to identify all TTP‐ and non‐TTP‐samples correctly, resulting in sensitivities and specificities of 100%.ConclusionBoth fully automated ADAMTS13 activity assays showed a good diagnostic performance and quantitative correlation among themselves, discriminating reliably between TTP‐ and non‐TTP‐patients.

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Section: Discussionsupporting

confidence: 65%