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Diagnostic performance and cutoff points of <t>plasma</t> <t>p-tau217</t> biomarkers for detecting amyloid pathology ( A ) ROC curves showing the AUCs of each plasma biomarker in discriminating amyloid pathology, as defined by the CSF Aβ42/Aβ40 ratio. ( B ) Simoa p-tau217, ( C ) Lumipulse p-tau217, and ( D ) Lumipulse p-tau217/Aβ42 × 10³ plots are shown. The red solid lines indicate the single-point cutoffs determined by the maximum Youden index. The red dashed lines represent the two-point cutoffs achieving >95% sensitivity and >95% specificity, with the intermediate zones shaded in red. For Lumipulse p-tau217, only one cutoff is shown as it meets both criteria using a single threshold. For Lumipulse p-tau217/Aβ42, the single-point and two-point cutoffs were identical, and thus only the red solid line is displayed. FDA-approved two-point cutoffs are indicated by blue dashed lines, with the intermediate zones shaded in blue.
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Diagnostic performance and cutoff points of <t>plasma</t> <t>p-tau217</t> biomarkers for detecting amyloid pathology ( A ) ROC curves showing the AUCs of each plasma biomarker in discriminating amyloid pathology, as defined by the CSF Aβ42/Aβ40 ratio. ( B ) Simoa p-tau217, ( C ) Lumipulse p-tau217, and ( D ) Lumipulse p-tau217/Aβ42 × 10³ plots are shown. The red solid lines indicate the single-point cutoffs determined by the maximum Youden index. The red dashed lines represent the two-point cutoffs achieving >95% sensitivity and >95% specificity, with the intermediate zones shaded in red. For Lumipulse p-tau217, only one cutoff is shown as it meets both criteria using a single threshold. For Lumipulse p-tau217/Aβ42, the single-point and two-point cutoffs were identical, and thus only the red solid line is displayed. FDA-approved two-point cutoffs are indicated by blue dashed lines, with the intermediate zones shaded in blue.
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Clinical utility assessment of <t>plasma</t> <t>p‐tau217</t> for amyloid detection using a two‐cutoff approach. Distribution of plasma p‐tau217 values with 95% sensitivity (lower line) and specificity (upper line) thresholds. Amyloid PET positivity was defined by visual reads (positive vs. negative). For amyloid PET positivity, the lower (95% sensitivity) and upper (95% specificity) cutoffs were 0.145 and 0.490 pg/mL for Simoa, 0.284 and 0.464 pg/mL for Ella, and 0.176 and 0.238 pg/mL for Lumipulse. Gray zones (intermediate‐risk) were smallest for Ella assays (4.4%), followed by Lumipulse (8.8%) and Simoa (49.6%) assays. Low‐risk group proportions: Ella (46.0%), Lumipulse (20.3%), Simoa (9.7%). Dotted lines indicate assay LLOQs (Simoa: 0.060 pg/mL; Lumipulse: 0.063 pg/mL; Ella: lot‐specific LLOQ 0.13 pg/mL and nominal LLOQ 0.32 pg/mL). Black filled circles denote non‐AD participants
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Image Search Results


Diagnostic performance and cutoff points of plasma p-tau217 biomarkers for detecting amyloid pathology ( A ) ROC curves showing the AUCs of each plasma biomarker in discriminating amyloid pathology, as defined by the CSF Aβ42/Aβ40 ratio. ( B ) Simoa p-tau217, ( C ) Lumipulse p-tau217, and ( D ) Lumipulse p-tau217/Aβ42 × 10³ plots are shown. The red solid lines indicate the single-point cutoffs determined by the maximum Youden index. The red dashed lines represent the two-point cutoffs achieving >95% sensitivity and >95% specificity, with the intermediate zones shaded in red. For Lumipulse p-tau217, only one cutoff is shown as it meets both criteria using a single threshold. For Lumipulse p-tau217/Aβ42, the single-point and two-point cutoffs were identical, and thus only the red solid line is displayed. FDA-approved two-point cutoffs are indicated by blue dashed lines, with the intermediate zones shaded in blue.

Journal: The Journal of Prevention of Alzheimer's Disease

Article Title: Evaluation of plasma p-tau217 biomarkers in detecting amyloid pathology and predicting cognitive outcomes: Observations from Japanese Alzheimer’s disease neuroimaging initiative cohort

doi: 10.1016/j.tjpad.2026.100502

Figure Lengend Snippet: Diagnostic performance and cutoff points of plasma p-tau217 biomarkers for detecting amyloid pathology ( A ) ROC curves showing the AUCs of each plasma biomarker in discriminating amyloid pathology, as defined by the CSF Aβ42/Aβ40 ratio. ( B ) Simoa p-tau217, ( C ) Lumipulse p-tau217, and ( D ) Lumipulse p-tau217/Aβ42 × 10³ plots are shown. The red solid lines indicate the single-point cutoffs determined by the maximum Youden index. The red dashed lines represent the two-point cutoffs achieving >95% sensitivity and >95% specificity, with the intermediate zones shaded in red. For Lumipulse p-tau217, only one cutoff is shown as it meets both criteria using a single threshold. For Lumipulse p-tau217/Aβ42, the single-point and two-point cutoffs were identical, and thus only the red solid line is displayed. FDA-approved two-point cutoffs are indicated by blue dashed lines, with the intermediate zones shaded in blue.

Article Snippet: Plasma p-tau217 was measured using both Lumipulse G pTau217 Plasma kit on the LUMIPULSE G1200 and Simoa ALZpath kit on HD-X platform (Quanterix, Billerica, MA, USA).

Techniques: Diagnostic Assay, Clinical Proteomics, Biomarker Discovery

Kaplan–Meier curves showing risk of conversion to AD dementia based on plasma p-tau217 biomarkers Participants were stratified into high (above cutoff) and low (below cutoff) groups using cutoff values determined by the maximum Youden index. ( A ) Simoa p-tau217, ( B ) Lumipulse p-tau217, and ( C ) Lumipulse p-tau217/Aβ42 ratio. Participants in the high-biomarker group exhibited significantly higher rates of conversion to AD dementia during follow-up. Log-rank test p-values were as follows: Simoa p-tau217 (p = 0.002), Lumipulse p-tau217 (p < 0.001), and Lumipulse p-tau217/Aβ42 (p < 0.001). Numbers at risk are shown in the bottom.

Journal: The Journal of Prevention of Alzheimer's Disease

Article Title: Evaluation of plasma p-tau217 biomarkers in detecting amyloid pathology and predicting cognitive outcomes: Observations from Japanese Alzheimer’s disease neuroimaging initiative cohort

doi: 10.1016/j.tjpad.2026.100502

Figure Lengend Snippet: Kaplan–Meier curves showing risk of conversion to AD dementia based on plasma p-tau217 biomarkers Participants were stratified into high (above cutoff) and low (below cutoff) groups using cutoff values determined by the maximum Youden index. ( A ) Simoa p-tau217, ( B ) Lumipulse p-tau217, and ( C ) Lumipulse p-tau217/Aβ42 ratio. Participants in the high-biomarker group exhibited significantly higher rates of conversion to AD dementia during follow-up. Log-rank test p-values were as follows: Simoa p-tau217 (p = 0.002), Lumipulse p-tau217 (p < 0.001), and Lumipulse p-tau217/Aβ42 (p < 0.001). Numbers at risk are shown in the bottom.

Article Snippet: Plasma p-tau217 was measured using both Lumipulse G pTau217 Plasma kit on the LUMIPULSE G1200 and Simoa ALZpath kit on HD-X platform (Quanterix, Billerica, MA, USA).

Techniques: Clinical Proteomics, Biomarker Discovery

Clinical utility assessment of plasma p‐tau217 for amyloid detection using a two‐cutoff approach. Distribution of plasma p‐tau217 values with 95% sensitivity (lower line) and specificity (upper line) thresholds. Amyloid PET positivity was defined by visual reads (positive vs. negative). For amyloid PET positivity, the lower (95% sensitivity) and upper (95% specificity) cutoffs were 0.145 and 0.490 pg/mL for Simoa, 0.284 and 0.464 pg/mL for Ella, and 0.176 and 0.238 pg/mL for Lumipulse. Gray zones (intermediate‐risk) were smallest for Ella assays (4.4%), followed by Lumipulse (8.8%) and Simoa (49.6%) assays. Low‐risk group proportions: Ella (46.0%), Lumipulse (20.3%), Simoa (9.7%). Dotted lines indicate assay LLOQs (Simoa: 0.060 pg/mL; Lumipulse: 0.063 pg/mL; Ella: lot‐specific LLOQ 0.13 pg/mL and nominal LLOQ 0.32 pg/mL). Black filled circles denote non‐AD participants

Journal: Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring

Article Title: Comparison of three plasma p‐tau217 assays to detect PET‐confirmed Alzheimer's pathologies

doi: 10.1002/dad2.70294

Figure Lengend Snippet: Clinical utility assessment of plasma p‐tau217 for amyloid detection using a two‐cutoff approach. Distribution of plasma p‐tau217 values with 95% sensitivity (lower line) and specificity (upper line) thresholds. Amyloid PET positivity was defined by visual reads (positive vs. negative). For amyloid PET positivity, the lower (95% sensitivity) and upper (95% specificity) cutoffs were 0.145 and 0.490 pg/mL for Simoa, 0.284 and 0.464 pg/mL for Ella, and 0.176 and 0.238 pg/mL for Lumipulse. Gray zones (intermediate‐risk) were smallest for Ella assays (4.4%), followed by Lumipulse (8.8%) and Simoa (49.6%) assays. Low‐risk group proportions: Ella (46.0%), Lumipulse (20.3%), Simoa (9.7%). Dotted lines indicate assay LLOQs (Simoa: 0.060 pg/mL; Lumipulse: 0.063 pg/mL; Ella: lot‐specific LLOQ 0.13 pg/mL and nominal LLOQ 0.32 pg/mL). Black filled circles denote non‐AD participants

Article Snippet: Simoa p‐tau217 immunoassay (ALZpath p‐tau217 assay, Quanterix, Billerica, MA) has been validated as a fit‐for‐purpose assay.

Techniques: Clinical Proteomics

Correlations of plasma p‐tau217 concentrations with the quantitative measures of amyloid and tau PET imaging. Correlations between plasma p‐tau217 and amyloid PET SUVRs for three assays; Ella showed the strongest association ( r = 0.757), followed by Lumipulse ( r = 0.654) and Simoa ( r = 0.639). (B) Correlations with tau PET SUVRs; Lumipulse showed the highest correlation ( r = 0.770), followed by Ella ( r = 0.704) and Simoa ( r = 0.656). Linear regression lines with 95% confidence intervals (shaded areas) are shown. All correlations were statistically significant ( p < 0.0001). PET, positron emission tomography; SUVR, standardized uptake value ratio

Journal: Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring

Article Title: Comparison of three plasma p‐tau217 assays to detect PET‐confirmed Alzheimer's pathologies

doi: 10.1002/dad2.70294

Figure Lengend Snippet: Correlations of plasma p‐tau217 concentrations with the quantitative measures of amyloid and tau PET imaging. Correlations between plasma p‐tau217 and amyloid PET SUVRs for three assays; Ella showed the strongest association ( r = 0.757), followed by Lumipulse ( r = 0.654) and Simoa ( r = 0.639). (B) Correlations with tau PET SUVRs; Lumipulse showed the highest correlation ( r = 0.770), followed by Ella ( r = 0.704) and Simoa ( r = 0.656). Linear regression lines with 95% confidence intervals (shaded areas) are shown. All correlations were statistically significant ( p < 0.0001). PET, positron emission tomography; SUVR, standardized uptake value ratio

Article Snippet: Simoa p‐tau217 immunoassay (ALZpath p‐tau217 assay, Quanterix, Billerica, MA) has been validated as a fit‐for‐purpose assay.

Techniques: Clinical Proteomics, Imaging, Positron Emission Tomography

Residual analyses of plasma p‐tau217 across tertiles of amyloid burden in patients with AD. Residuals were derived from linear regression of plasma p‐tau217 on amyloid PET SUVR. Correlations with tau PET SUVR are shown within each tertile. Tertiles were defined within amyloid PET–positive AD participants to reflect relative amyloid burden (Centiloid). (* p < 0.05, ** p < 0.01, *** p < 0.001).

Journal: Alzheimer's & Dementia : Diagnosis, Assessment & Disease Monitoring

Article Title: Comparison of three plasma p‐tau217 assays to detect PET‐confirmed Alzheimer's pathologies

doi: 10.1002/dad2.70294

Figure Lengend Snippet: Residual analyses of plasma p‐tau217 across tertiles of amyloid burden in patients with AD. Residuals were derived from linear regression of plasma p‐tau217 on amyloid PET SUVR. Correlations with tau PET SUVR are shown within each tertile. Tertiles were defined within amyloid PET–positive AD participants to reflect relative amyloid burden (Centiloid). (* p < 0.05, ** p < 0.01, *** p < 0.001).

Article Snippet: Simoa p‐tau217 immunoassay (ALZpath p‐tau217 assay, Quanterix, Billerica, MA) has been validated as a fit‐for‐purpose assay.

Techniques: Clinical Proteomics, Derivative Assay

Interaction effects between AD biomarkers and LC intensity on T1‐weighted MRI in cognitively unimpaired older adults, using voxelwise multiple regression. Positive interactions between LC intensity and (a) amyloid PET, (b) plasma p‐tau231, (c) plasma NfL, and (d) plasma GFAP on T1‐weighted MRI. A, Thresholded at P = 0.001 uncorrected for multiple comparisons, minimum cluster size = 50. B, Unthresholded maps. a, d, n = 71. b, n = 67 (four missing measures). c, n = 70 (one outlier on NfL level excluded). Multiple regressions corrected for age, sex, level of education, and experimental group. a, Additionally corrected for delay between amyloid PET data acquisition and other data acquisitions. AD, Alzheimer's disease; GFAP, glial fibrillary acidic protein; LC, locus coeruleus; MRI, magnetic resonance imaging; NfL, neurofilament light chain; PET, positron emission tomography; p‐tau, phosphorylated tau.

Journal: Alzheimer's & Dementia

Article Title: Altered locus coeruleus links to atrophy and hypometabolism in individuals with high Alzheimer's disease biomarkers

doi: 10.1002/alz.71212

Figure Lengend Snippet: Interaction effects between AD biomarkers and LC intensity on T1‐weighted MRI in cognitively unimpaired older adults, using voxelwise multiple regression. Positive interactions between LC intensity and (a) amyloid PET, (b) plasma p‐tau231, (c) plasma NfL, and (d) plasma GFAP on T1‐weighted MRI. A, Thresholded at P = 0.001 uncorrected for multiple comparisons, minimum cluster size = 50. B, Unthresholded maps. a, d, n = 71. b, n = 67 (four missing measures). c, n = 70 (one outlier on NfL level excluded). Multiple regressions corrected for age, sex, level of education, and experimental group. a, Additionally corrected for delay between amyloid PET data acquisition and other data acquisitions. AD, Alzheimer's disease; GFAP, glial fibrillary acidic protein; LC, locus coeruleus; MRI, magnetic resonance imaging; NfL, neurofilament light chain; PET, positron emission tomography; p‐tau, phosphorylated tau.

Article Snippet: Plasma p‐tau231, NfL, and GFAP were measured using SIMOA technology with commercial kits from Quanterix (p‐Tau231 Advantage #102,292, Neurology 2‐plexB #103,520) on an HD‐X analyzer (Quanterix; PMID: 20,495,550).

Techniques: Clinical Proteomics, Magnetic Resonance Imaging, Positron Emission Tomography

Interaction effects between AD biomarkers and LC volume on T1‐weighted MRI in cognitively unimpaired older adults, using voxelwise multiple regression. Positive interactions between LC volume and (a) amyloid PET, (b) plasma p‐tau231, (c) plasma NfL, and (d) plasma GFAP on T1‐weighted MRI. A, Thresholded at P = 0.001 uncorrected for multiple comparisons, minimum cluster size = 50. B, Unthresholded maps. a, d, n = 71. b, n = 67 (four missing measures). c, n = 70 (one outlier on NfL level excluded). Multiple regressions corrected for age, sex, level of education, and experimental group. LC volumes were corrected for total intracranial volume. a, Additionally corrected for delay between amyloid PET data acquisition and other data acquisitions. AD, Alzheimer's disease; GFAP, glial fibrillary acidic protein; LC, locus coeruleus; MRI, magnetic resonance imaging; NfL, neurofilament light chain; PET, positron emission tomography; p‐tau, phosphorylated tau.

Journal: Alzheimer's & Dementia

Article Title: Altered locus coeruleus links to atrophy and hypometabolism in individuals with high Alzheimer's disease biomarkers

doi: 10.1002/alz.71212

Figure Lengend Snippet: Interaction effects between AD biomarkers and LC volume on T1‐weighted MRI in cognitively unimpaired older adults, using voxelwise multiple regression. Positive interactions between LC volume and (a) amyloid PET, (b) plasma p‐tau231, (c) plasma NfL, and (d) plasma GFAP on T1‐weighted MRI. A, Thresholded at P = 0.001 uncorrected for multiple comparisons, minimum cluster size = 50. B, Unthresholded maps. a, d, n = 71. b, n = 67 (four missing measures). c, n = 70 (one outlier on NfL level excluded). Multiple regressions corrected for age, sex, level of education, and experimental group. LC volumes were corrected for total intracranial volume. a, Additionally corrected for delay between amyloid PET data acquisition and other data acquisitions. AD, Alzheimer's disease; GFAP, glial fibrillary acidic protein; LC, locus coeruleus; MRI, magnetic resonance imaging; NfL, neurofilament light chain; PET, positron emission tomography; p‐tau, phosphorylated tau.

Article Snippet: Plasma p‐tau231, NfL, and GFAP were measured using SIMOA technology with commercial kits from Quanterix (p‐Tau231 Advantage #102,292, Neurology 2‐plexB #103,520) on an HD‐X analyzer (Quanterix; PMID: 20,495,550).

Techniques: Clinical Proteomics, Magnetic Resonance Imaging, Positron Emission Tomography

Interaction effects between AD biomarkers and LC intensity on FDG PET in cognitively unimpaired older adults, using voxelwise multiple regression. Positive interactions between LC intensity and (a) amyloid PET, (b) plasma p‐tau231, (c) plasma NfL, and (d) plasma GFAP on FDG PET. A, Thresholded at P = 0.001 uncorrected for multiple comparisons, minimum cluster size = 50. B, Unthresholded maps. a, d, n = 69. b, n = 65 (four missing measures). c, n = 68 (one outlier on NfL level excluded). Multiple regressions corrected for age, sex, level of education, and experimental group. a, Additionally corrected for delay between amyloid PET data acquisition and other data acquisitions. AD, Alzheimer's disease; FDG, fluorodeoxyglucose; GFAP, glial fibrillary acidic protein; LC, locus coeruleus; NfL, neurofilament light chain; PET, positron emission tomography; p‐tau, phosphorylated tau.

Journal: Alzheimer's & Dementia

Article Title: Altered locus coeruleus links to atrophy and hypometabolism in individuals with high Alzheimer's disease biomarkers

doi: 10.1002/alz.71212

Figure Lengend Snippet: Interaction effects between AD biomarkers and LC intensity on FDG PET in cognitively unimpaired older adults, using voxelwise multiple regression. Positive interactions between LC intensity and (a) amyloid PET, (b) plasma p‐tau231, (c) plasma NfL, and (d) plasma GFAP on FDG PET. A, Thresholded at P = 0.001 uncorrected for multiple comparisons, minimum cluster size = 50. B, Unthresholded maps. a, d, n = 69. b, n = 65 (four missing measures). c, n = 68 (one outlier on NfL level excluded). Multiple regressions corrected for age, sex, level of education, and experimental group. a, Additionally corrected for delay between amyloid PET data acquisition and other data acquisitions. AD, Alzheimer's disease; FDG, fluorodeoxyglucose; GFAP, glial fibrillary acidic protein; LC, locus coeruleus; NfL, neurofilament light chain; PET, positron emission tomography; p‐tau, phosphorylated tau.

Article Snippet: Plasma p‐tau231, NfL, and GFAP were measured using SIMOA technology with commercial kits from Quanterix (p‐Tau231 Advantage #102,292, Neurology 2‐plexB #103,520) on an HD‐X analyzer (Quanterix; PMID: 20,495,550).

Techniques: Clinical Proteomics, Positron Emission Tomography

Interaction effects between AD biomarkers and LC volume on FDG PET in cognitively unimpaired older adults, using voxelwise multiple regression. Positive interactions between LC volume and (a) amyloid PET, (b) plasma p‐tau231, (c) plasma NfL, and (d) plasma GFAP on FDG PET. A, Thresholded at P = 0.001 uncorrected for multiple comparisons, minimum cluster size = 50. White contours highlight significant clusters after family‐wise error correction at the cluster level ( P < 0.05). B, Unthresholded maps. a, d, n = 69. b, n = 65 (four missing measures). c, n = 68 (one outlier on NfL level excluded). Multiple regressions corrected for age, sex, level of education, and experimental group. LC volumes were corrected for total intracranial volume. a, Additionally corrected for delay between amyloid PET data acquisition and other data acquisitions. AD, Alzheimer's disease; FDG, fluorodeoxyglucose; GFAP, glial fibrillary acidic protein; LC, locus coeruleus; NfL, neurofilament light chain; PET, positron emission tomography; p‐tau, phosphorylated tau.

Journal: Alzheimer's & Dementia

Article Title: Altered locus coeruleus links to atrophy and hypometabolism in individuals with high Alzheimer's disease biomarkers

doi: 10.1002/alz.71212

Figure Lengend Snippet: Interaction effects between AD biomarkers and LC volume on FDG PET in cognitively unimpaired older adults, using voxelwise multiple regression. Positive interactions between LC volume and (a) amyloid PET, (b) plasma p‐tau231, (c) plasma NfL, and (d) plasma GFAP on FDG PET. A, Thresholded at P = 0.001 uncorrected for multiple comparisons, minimum cluster size = 50. White contours highlight significant clusters after family‐wise error correction at the cluster level ( P < 0.05). B, Unthresholded maps. a, d, n = 69. b, n = 65 (four missing measures). c, n = 68 (one outlier on NfL level excluded). Multiple regressions corrected for age, sex, level of education, and experimental group. LC volumes were corrected for total intracranial volume. a, Additionally corrected for delay between amyloid PET data acquisition and other data acquisitions. AD, Alzheimer's disease; FDG, fluorodeoxyglucose; GFAP, glial fibrillary acidic protein; LC, locus coeruleus; NfL, neurofilament light chain; PET, positron emission tomography; p‐tau, phosphorylated tau.

Article Snippet: Plasma p‐tau231, NfL, and GFAP were measured using SIMOA technology with commercial kits from Quanterix (p‐Tau231 Advantage #102,292, Neurology 2‐plexB #103,520) on an HD‐X analyzer (Quanterix; PMID: 20,495,550).

Techniques: Clinical Proteomics, Positron Emission Tomography