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Article ; Online: Anti-phosphatidyl-serine/prothrombin (aPS/PT) antibodies are superior predictors of LAC presence and APS diagnoses: A single center study.

Saadalla, Abdulrahman / Nandakumar, Vijayalakshmi

Clinica chimica acta; international journal of clinical chemistry

2024 Volume 554, Page(s) 117761

Abstract: Background and aims: Several non-criteria (NC) anti-phospholipid antibodies (APLA) have been proposed as candidates for antiphospholipid antibody syndrome (APS) diagnosis. The objectives of this study were 1) to determine the association of five ... ...

Abstract	Background and aims: Several non-criteria (NC) anti-phospholipid antibodies (APLA) have been proposed as candidates for antiphospholipid antibody syndrome (APS) diagnosis. The objectives of this study were 1) to determine the association of five different NC-APLA with positivity for Lupus anti-coagulant (LAC) and the criteria antibodies anti-cardiolipin (aCL) and anti-beta glycoprotein (aB2GPI), and 2) to assess the ability of NC-APLA to predict LAC presence and clinical APS diagnoses. Material and methods: Results from 486 patients tested for LAC and APLA were retrieved. Patients were grouped according to LAC and serology positivity into three groups: Single-positives (SP) for LAC, aCL or aB2GPI; Double-positives for aCL and aB2GPI; Triple-positives (TP) for LAC, aCL and aB2GPI. NC-ALPA titers were compared between LAC-positive and negative and APS and non-APS patients. Results: Forty-two of 486 patients were LAC-positive and 28 were diagnosed with APS. All criteria and NC-APLA titers were significantly higher in TP than SP patients. ROC analyses based on LAC status showed highest area under the curve (AUC, 95% CI) for aPS/PT IgG (0.75, 0.65-0.85) and aPS/PT IgM (0.73, 0.63-0.82). Based on APS diagnosis, aPS/PT IgM achieved highest AUC (0.87; 0.79-0.95). Conclusion: Anti-phosphatidyl-serine/prothrombin (aPS/PT) antibodies are superior predictors of LAC presence and APS diagnoses.
MeSH term(s)	Humans ; Antiphospholipid Syndrome ; Prothrombin ; Phosphatidylserines ; Antibodies, Antiphospholipid ; Antibodies, Anticardiolipin ; Immunoglobulin M ; Serine ; Lupus Coagulation Inhibitor
Chemical Substances	Prothrombin (9001-26-7) ; Phosphatidylserines ; Antibodies, Antiphospholipid ; Antibodies, Anticardiolipin ; Immunoglobulin M ; Serine (452VLY9402) ; Lupus Coagulation Inhibitor
Language	English
Publishing date	2024-01-07
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	80228-1
ISSN	1873-3492 ; 0009-8981
ISSN (online)	1873-3492
ISSN	0009-8981
DOI	10.1016/j.cca.2024.117761
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Article ; Online: The Now and Beyond of Tumor Mutational Burden as a Predictor of Response to Immune Checkpoint Inhibitors.

Nandakumar, Vijayalakshmi / Mills, John R

Clinical chemistry

2020 Volume 65, Issue 2, Page(s) 357

MeSH term(s)	Antineoplastic Agents/therapeutic use ; Biomarkers, Tumor ; Humans ; Mutation ; Neoplasms/drug therapy ; Neoplasms/genetics ; Neoplasms/immunology ; Tumor Burden/genetics
Chemical Substances	Antineoplastic Agents ; Biomarkers, Tumor
Language	English
Publishing date	2020-02-26
Publishing country	England
Document type	News
ZDB-ID	80102-1
ISSN	1530-8561 ; 0009-9147
ISSN (online)	1530-8561
ISSN	0009-9147
DOI	10.1373/clinchem.2018.295097
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Article: Performance of Anti-Carbamylated Protein Antibody Testing in the Routine Evaluation of Rheumatoid Arthritis from a Single Center.

Nelson, Heather A / Novis, Camille L / Lebiedz-Odrobina, Dorota / Nandakumar, Vijayalakshmi

The journal of applied laboratory medicine

2023 Volume 9, Issue 2, Page(s) 251–261

Abstract: Background: Detection of anticyclic citrullinated peptide antibodies (anti-CCP) and rheumatoid factors (RF) in sera support the diagnosis of rheumatoid arthritis (RA); however, these markers are not detected in about 20% of RA patients. More recently, ... ...

Abstract	Background: Detection of anticyclic citrullinated peptide antibodies (anti-CCP) and rheumatoid factors (RF) in sera support the diagnosis of rheumatoid arthritis (RA); however, these markers are not detected in about 20% of RA patients. More recently, antibodies against carbamylated proteins (anti-CarP) have emerged with implications for preclinical RA diagnosis. The objective of this study was to assess the clinical performance of anti-CarP and correlate with disease severity in routine clinical practice. Methods: Retrospective chart review of 331 subjects submitted for RA panel serology: 136 clinically defined RA-positive and 195 RA-negative patients. Fifty additional individuals were recruited for healthy controls. Patients' sera were tested for anti-CCP, anti-CarP, and RF antibodies. Clinical performance characteristics were evaluated for anti-CarP individually and in combination with anti-CCP and RF. Documented erosions and synovitis were correlated with anti-CarP positivity. Results: Anti-CarP had a clinical sensitivity and specificity of 27% and 94%, respectively, for established RA. This sensitivity was lower than anti-CCP (79%) and RF (85%). The specificity of anti-CarP was similar to anti-CCP (93%) and higher than RF (69%). Anti-CarP in combination with anti-CCP and RF increased specificity (100%) but decreased sensitivity (21%). There was no correlation of anti-CarP positivity with presence of bone erosions; however, there was an increase in anti-CarP positivity among patients with synovitis. Conclusions: Anti-CarP demonstrates high specificity in diagnosis of established RA but lacks clinical sensitivity. In combination, anti-CarP does not improve clinical performance of anti-CCP and RF but may be useful in anti-CCP negative patients and in identifying patients with more active disease.
MeSH term(s)	Humans ; Anti-Citrullinated Protein Antibodies ; Retrospective Studies ; Arthritis, Rheumatoid/diagnosis ; Rheumatoid Factor ; Synovitis
Chemical Substances	Anti-Citrullinated Protein Antibodies ; Rheumatoid Factor (9009-79-4)
Language	English
Publishing date	2023-11-08
Publishing country	England
Document type	Journal Article
ISSN	2576-9456
ISSN	2576-9456
DOI	10.1093/jalm/jfad088
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Article ; Online: Discouraging Non-ELISA antiphospholipid antibody assays in antiphospholipid syndrome classification may hinder clinical research.

Zhang, Xiaochun Susan / Bizzaro, Nicola / Tebo, Anne E / Nandakumar, Vijayalakshmi / Infantino, Maria / Carbone, Teresa / Bossuyt, Xavier / Damoiseaux, Jan

Immunologic research

2023

Language	English
Publishing date	2023-12-12
Publishing country	United States
Document type	Letter
ZDB-ID	632857-x
ISSN	1559-0755 ; 0257-277X
ISSN (online)	1559-0755
ISSN	0257-277X
DOI	10.1007/s12026-023-09443-8
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Article ; Online: Evaluation of

Nandakumar, Vijayalakshmi / Bornhorst, Joshua A / Algeciras-Schimnich, Alicia

Annals of clinical and laboratory science

2021 Volume 51, Issue 1, Page(s) 3–11

Abstract: Prostate Health Index ( ...

Abstract	Prostate Health Index (
MeSH term(s)	Aged ; Biopsy ; Cohort Studies ; Diagnosis, Differential ; Early Detection of Cancer/methods ; Humans ; Kallikreins/analysis ; Male ; Middle Aged ; Prostate-Specific Antigen/analysis ; Prostatic Neoplasms/diagnosis ; Prostatic Neoplasms/pathology ; ROC Curve ; Retrospective Studies
Chemical Substances	KLK3 protein, human (EC 3.4.21.-) ; Kallikreins (EC 3.4.21.-) ; Prostate-Specific Antigen (EC 3.4.21.77)
Language	English
Publishing date	2021-03-02
Publishing country	United States
Document type	Journal Article
ZDB-ID	193092-8
ISSN	1550-8080 ; 0091-7370 ; 0095-8905
ISSN (online)	1550-8080
ISSN	0091-7370 ; 0095-8905
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Article ; Online: Presence of anti-gp210 or anti-sp100 antibodies in AMA-positive patients may help support a diagnosis of primary biliary cholangitis.

Jaskowski, Troy D / Nandakumar, Vijayalakshmi / Novis, Camille L / Palmer, Michael / Tebo, Anne E

Clinica chimica acta; international journal of clinical chemistry

2023 Volume 540, Page(s) 117219

Abstract: Background: Anti-mitochondrial antibody (AMA) positivity is not always associated with primary biliary cholangitis (PBC). We aimed to determine the additional value of anti-sp100 or anti-gp210 antibody in AMA-positive patients for PBC.: Methods: ... ...

Abstract	Background: Anti-mitochondrial antibody (AMA) positivity is not always associated with primary biliary cholangitis (PBC). We aimed to determine the additional value of anti-sp100 or anti-gp210 antibody in AMA-positive patients for PBC. Methods: Patients (n = 190) and healthy donors (n = 50) were evaluated for AMA, anti-gp210 and anti-sp100 antibodies by ELISA. Antibody frequencies in cohorts and performance characteristics in some patients categorized as 'definitive-', 'probable-', and 'no PBC' were determined following review of their charts. Results: Of the patients (n = 190), 38.4% were AMA-positive (n = 73) and 61.6% AMA-negative (n = 117). Frequency of anti-sp100 or anti-gp210 antibody was 17.8%, 2.6%, and 0% in AMA-positive, AMA-negative and healthy controls, respectively. Clinical data was available for 63 of 73 AMA-positive patients with 28.6%, 22.2%, and 49.2% categorized as definite, probable, and no PBC, respectively. Patients with definite PBC had higher mean levels of AMA and frequencies of sp100 or gp210 antibody compared to other groups. Sensitivities were low (anti-sp100: 18.8% and anti-gp210: 16.7%) with specificities above 98.0% for both. Conclusion: AMA-positive patients positive for anti-sp100 or anti-gp210 antibody were more likely to have a diagnosis of definite or probable PBC than those with AMA alone. Use of all tests is likely to improve characterization of patients at-risk for PBC.
MeSH term(s)	Humans ; Autoantibodies ; Liver Cirrhosis, Biliary/diagnosis ; Antibodies, Antinuclear ; Mitochondria ; Enzyme-Linked Immunosorbent Assay
Chemical Substances	Autoantibodies ; Antibodies, Antinuclear
Language	English
Publishing date	2023-01-04
Publishing country	Netherlands
Document type	Journal Article
ZDB-ID	80228-1
ISSN	1873-3492 ; 0009-8981
ISSN (online)	1873-3492
ISSN	0009-8981
DOI	10.1016/j.cca.2023.117219
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Article ; Online: Performance Assessment of a Novel Multianalyte Methodology for Celiac Disease Biomarker Detection and Evaluation of the Serology-Alone Criteria for Biopsy-Free Diagnosis.

Novis, Camille Leite / Wahl, Edward / Camacho, Eric / Aure, Mary Ann / Mahler, Michael / Nandakumar, Vijayalakshmi

Archives of pathology & laboratory medicine

2023 Volume 147, Issue 12, Page(s) 1422–1430

Abstract: Context.—: Serology plays a vital role in celiac disease (CD) diagnosis, and the latest European guidelines advocate for biopsy-free diagnoses in patients with ≥10× the upper limit of normal (ULN) of anti-tissue transglutaminase (tTG) immunoglobulin A ( ... ...

Abstract	Context.—: Serology plays a vital role in celiac disease (CD) diagnosis, and the latest European guidelines advocate for biopsy-free diagnoses in patients with ≥10× the upper limit of normal (ULN) of anti-tissue transglutaminase (tTG) immunoglobulin A (IgA) antibodies. Objective.—: To assess performance characteristics of a novel automated particle-based multianalyte technology (Aptiva) for anti-tTG and anti-deamidated gliadin peptide (DGP) antibody detection as compared to the traditional enzyme-linked immunosorbent assay (QUANTA Lite). Performance characteristics of the ≥10× ULN anti-tTG IgA criteria for serologic diagnosis of CD were also evaluated. Design.—: Sera samples from 703 patients were tested for anti-tTG IgA, anti-tTG immunoglobulin G (IgG), anti-DGP IgA, and anti-DGP IgG antibodies on both platforms. In total, 127 patients had medical information and were classified as CD-positive (n = 58) and CD-negative (n = 69) based on biopsy results. Clinical performance characteristics were evaluated. Results.—: Anti-tTG IgA detection showed equal clinical sensitivity and specificity of 91% sensitivity and 99% specificity on both platforms. Anti-tTG IgG resulted in moderate sensitivity of 69% and 72%, but high specificity of 100% and 94% on Aptiva and QUANTA Lite, respectively. Anti-DGP IgG displayed comparable sensitivity of 90% and 81%, and a specificity of 94% and 99%, on Aptiva and QUANTA Lite, respectively. Anti-DGP IgA demonstrated greater sensitivity on QUANTA Lite (83%) than Aptiva (69%) and similar specificities of 97% and 98% on QUANTA Lite and Aptiva, respectively. At ≥10× ULN levels for anti-tTG IgA, Aptiva displayed a sensitivity of 72% and a specificity of 100%, and QUANTA Lite showed a sensitivity of 69% and a specificity of 100%. Conclusions.—: Aptiva is a reliable method to measure CD biomarkers with reduced hands-on necessity and high-throughput capabilities. This study supports the use of a ≥10× ULN anti-tTG IgA biopsy-free approach for serologic diagnosis of CD.
MeSH term(s)	Humans ; Transglutaminases ; Celiac Disease ; Immunoglobulin G ; Immunoglobulin A ; Sensitivity and Specificity ; Autoantibodies ; Biopsy ; Gliadin ; Biomarkers
Chemical Substances	Transglutaminases (EC 2.3.2.13) ; Immunoglobulin G ; Immunoglobulin A ; Autoantibodies ; Gliadin (9007-90-3) ; Biomarkers
Language	English
Publishing date	2023-02-14
Publishing country	United States
Document type	Journal Article
ZDB-ID	194119-7
ISSN	1543-2165 ; 0363-0153 ; 0096-8528 ; 0003-9985
ISSN (online)	1543-2165
ISSN	0363-0153 ; 0096-8528 ; 0003-9985
DOI	10.5858/arpa.2022-0385-OA
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Article ; Online: Evaluation of plasma ACTH stability using the Roche Elecsys immunoassay.

Nandakumar, Vijayalakshmi / Paul Theobald, J / Algeciras-Schimnich, Alicia

Clinical biochemistry

2020 Volume 81, Page(s) 59–62

Abstract: Background: Adrenocorticotropic hormone (ACTH) has been reported to be labile in blood due to proteolytic degradation and stringent procedures are followed to prevent in vitro degradation after sample collection.: Objective: The purpose of this study ...

Abstract	Background: Adrenocorticotropic hormone (ACTH) has been reported to be labile in blood due to proteolytic degradation and stringent procedures are followed to prevent in vitro degradation after sample collection. Objective: The purpose of this study was to examine the effect of time and temperature before and after separation of plasma from cells in the quantitation of plasma ACTH. Methods: Our current protocol includes sample collection in a pre-chilled tube, transport on ice and immediate centrifugation at 4 °C. These reference conditions were compared against sample processing in tubes and centrifuge set at room-temperature; using delayed centrifugation at 4 °C. ACTH stability was evaluated at ambient and refrigerated temperatures after collection and plasma separation using the reference protocol. Plasma samples were analyzed using the Roche Elecsys ACTH immunoassay. Results: Quantification of ACTH was not impacted by the use of non-chilled tubes and centrifuge and up to a 4 h delay in separation of plasma from cells. Average percent differences in plasma ACTH concentration from time 0 was <10% up to 12 h at ambient temperature. Refrigeration of plasma did not preserve ACTH stability at 12 h and longer storage resulted in significant ACTH degradation at both ambient and refrigerated temperatures. Conclusions: As supported by these data, previously recommended strict specimen collection and processing requirements are not necessary for measuring ACTH with the Roche Elecsys immunoassay.
MeSH term(s)	Adrenocorticotropic Hormone/blood ; Clinical Chemistry Tests/standards ; Humans ; Immunoassay/methods ; Plasma/chemistry ; Plasma/metabolism ; Temperature
Chemical Substances	Adrenocorticotropic Hormone (9002-60-2)
Language	English
Publishing date	2020-04-18
Publishing country	United States
Document type	Evaluation Study ; Journal Article
ZDB-ID	390372-2
ISSN	1873-2933 ; 0009-9120
ISSN (online)	1873-2933
ISSN	0009-9120
DOI	10.1016/j.clinbiochem.2020.04.004
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Zs.A 624: Show issues

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Article ; Online: Effect of pH on the Quantification of Common Chemistry Analytes in Body Fluid Specimens Using the Roche cobas Analyzer for Clinical Diagnostic Testing.

Nandakumar, Vijayalakshmi / Dolan, Christopher T / Baumann, Nikola A / Block, Darci R

American journal of clinical pathology

2021 Volume 156, Issue 5, Page(s) 722–727

Abstract: Objectives: To determine the influence of pH on recovery of analytes in body fluids (BFs), investigate the mechanism of pH interference, measure the frequency of abnormal-pH BFs received, and compare pH measured by meter and paper.: Methods: We ... ...

Abstract	Objectives: To determine the influence of pH on recovery of analytes in body fluids (BFs), investigate the mechanism of pH interference, measure the frequency of abnormal-pH BFs received, and compare pH measured by meter and paper. Methods: We performed pH titration in residual BFs. A low-pH BF was spiked and neutralized to investigate pH interference. We measured analytes on a Roche cobas c501 analyzer (Roche Diagnostics) and calculated the percent recovery. Measurement of pH using a meter and paper was conducted on 122 BF samples received in the laboratory. Results: Enzyme activity in BFs was unaffected when pH = 7.4-8.5 lactate dehydrogenase, pH = 7.3-10.2 amylase, pH = 6.0-9.9 lipase, and pH = 1.3-11.7 all other analytes. BFs had mean (range) pH of 8.0 (5.1-8.9), with a mean (range) difference (paper ‒ meter) of ‒0.4 (‒0.6 to 1.1). Conclusions: Irreversible loss of enzyme activity occurs in BFs at low pH. Few clinical BFs have pH < 7.0, but laboratories should incorporate pH measurement in BF workflows.
MeSH term(s)	Amylases/analysis ; Body Fluids/chemistry ; Diagnostic Tests, Routine/instrumentation ; Diagnostic Tests, Routine/methods ; Enzyme Assays/methods ; Humans ; Hydrogen-Ion Concentration ; L-Lactate Dehydrogenase/analysis ; Lipase/analysis
Chemical Substances	L-Lactate Dehydrogenase (EC 1.1.1.27) ; Lipase (EC 3.1.1.3) ; Amylases (EC 3.2.1.-)
Language	English
Publishing date	2021-06-02
Publishing country	England
Document type	Journal Article
ZDB-ID	2944-0
ISSN	1943-7722 ; 0002-9173
ISSN (online)	1943-7722
ISSN	0002-9173
DOI	10.1093/ajcp/aqab025
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Article ; Online: Paranasal Sinus Carcinoma Dissimulating as Alveolar Osteitis

Arulmozhi Nandakumar / K Vijayalakshmi / Ramya Ramados / A Kannan

Journal of Clinical and Diagnostic Research, Vol 12, Iss 2, Pp ZJ03-ZJ

2018 Volume 04

Keywords	diagnostic imaging ; malignant neoplasm ; maxillary sinus cancers ; paranasal sinus neoplasm ; Medicine ; R
Language	English
Publishing date	2018-02-01T00:00:00Z
Publisher	JCDR Research and Publications Private Limited
Document type	Article ; Online
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