Antiphospholipid Antibody Testing in a Maximum Care Hospital: Method-Dependent Differences
Abstract
:1. Introduction
2. Materials and Methods
2.1. Data Collection
2.2. Laboratory Assays
2.3. Statistical Analysis
3. Results
3.1. Concordances of Antiphospholipid Antibody Assays
3.1.1. Results of APL Measurements in the Entire Cohort
3.1.2. Results of APL Measurements in Patients with APS
3.2. Comparison of Antiphospholipid Antibody Levels between ELISA and CLIA Measurements
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Antiphospholipid Antibody | ELISA | CLIA |
---|---|---|
aCL IgG (GPL-U/mL) | >14.4 | >20 |
aCL IgM (MPL-U/mL) | >7.2 | >10 |
aß2GPI IgG (U/mL) | >14.4 | >20 |
aß2GPI IgM (U/mL) | >14.4 | >10 |
A | B | C | D | E | |
---|---|---|---|---|---|
Entire cohort | All aPL tests negative | Any aPL test positive | Any aPL test positive using ELISA | Any aPL test positive using CLIA | |
N | 946 | 810 | 136 | 92 | 94 |
Women | 466 (49%) | 386 (48%) | 80 (59%) | 56 (61%) | 56 (60%) |
Age | 51 (35–61) | 50 (33–61) | 54 (38–65) | 51 (36–65) | 54 (39–65) |
Clinical findings | |||||
Arterial or venous thrombosis | 143 (15%) | 89 (11%) | 54 (40%) | 25 (27%) | 30 (32%) |
Ischemic stroke | 482 (51%) | 436 (54%) | 46 (34%) | 29 (32%) | 34 (36%) |
Transient ischemic attack | 40 (4%) | 35 (4%) | 5 (4%) | 3 (3%) | 2 (2%) |
Obstetric complications | 36 (4%) | 27 (3%) | 9 (7%) | 8 (9%) | 8 (9%) |
Autoimmune diseases | |||||
Connective tissue diseases | 36 (4%) | 19 (2%) | 17 (13%) | 16 (17%) | 13 (14%) |
Vasculitis | 21 (2%) | 18 (2%) | 3 (2%) | 2 (2%) | 2 (2%) |
Others | 13 (1%) | 7 (1%) | 6 (4%) | 2 (2%) | 6 (6%) |
APS diagnosis | 55 (6%) | 4 (<1%) | 51 (38%) | 47 (51%) | 41 (44%) |
Primary APS | 38 (4%) | 3 (<1%) | 35 (26%) | 33 (36%) | 29 (31%) |
Secondary APS | 17 (2%) | 1 (<1%) | 16 (12%) | 14 (15%) | 12 (13%) |
Laboratory findings | |||||
LA (positive) | 46 (5%) | 22 (3%) | 24 (18%) | 23 (25%) | 20 (21%) |
dRVVT (screen) (s) | 31 (29–34) | 31 (29–34) | 33 (29–45) | 37 (31–52) | 32 (29–47) |
aPTT (Actin FS) (s) | 24 (23–27) | 24 (23–27) | 25 (23–27) | 26 (23–29) | 25 (23–28) |
aPTT (Actin FSL) (s) | 27 (25–28) | 26 (25–28) | 27 (25–31) | 29 (26–35) | 25 (27–31) |
Manufacturer thresholds | |||||
aCL IgG (positive) | 57 (6%) | - | 57 (42%) | 49 (53%) | 30 (32%) |
aCL IgM (positive) | 96 (10%) | - | 96 (71%) | 49 (53%) | 63 (67%) |
aß2GPI IgG (positive) | 54 (6%) | - | 54 (40%) | 31 (34%) | 30 (32%) |
aß2GPI IgM (positive) | 88 (9%) | - | 88 (65%) | 24 (26%) | 65 (69%) |
Moderate threshold (according to 2023 ACR/EULAR criteria) | |||||
aCL IgG (>40 GPL-U/mL) | 41 (4%) | - | 41 (30%) | 20 (22%) | 28 (30%) |
aCL IgM (>40 MPL-U/mL) | 24 (3%) | - | 24 (18%) | 6 (7%) | 20 (21%) |
aß2GPI IgG (>40 U/mL) | 29 (3%) | - | 29 (21%) | 10 (11%) | 28 (30%) |
aß2GPI IgM (>40 U/mL) | 25 (3%) | - | 25 (18%) | 12 (13%) | 21 (22%) |
CLIA | ||
---|---|---|
ELISA | ||
aCL IgG | negative | positive |
negative | 891 | 25 |
positive | 6 | 24 |
ELISA | ||
aCL IgM | negative | positive |
negative | 861 | 22 |
positive | 36 | 27 |
ELISA | ||
aß2GPI I IgG | negative | positive |
negative | 908 | 8 |
positive | 7 | 23 |
ELISA | ||
aß2GPI I IgM | negative | positive |
negative | 877 | 4 |
positive | 45 | 20 |
CLIA | ||
---|---|---|
ELISA | ||
aCL IgG | negative | positive |
negative | 20 | 3 |
positive | 8 | 24 |
ELISA | ||
aCL IgM | negative | positive |
negative | 23 | 8 |
positive | 7 | 17 |
ELISA | ||
aß2GPI I IgG | negative | positive |
negative | 25 | 6 |
positive | 3 | 21 |
ELISA | ||
aß2GPI I IgM | negative | positive |
negative | 33 | 5 |
positive | 1 | 16 |
ELISA | CLIA | p-Value | |
---|---|---|---|
aCL IgG (GPL-U/mL) | 30 (10–47) | 38 (0–304) | 0.0071 |
aCL IgM (MPL-U/mL) | 6 (3–23) | 10 (0–36) | 0.0258 |
aß2GPI IgG (U/mL) | 10 (2–34) | 56 (0–407) | 0.0003 |
aß2GPI IgM (U/mL) | 5 (2–22) | 7 (2–29) | 0.0022 |
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Kocijancic, M.; Goj, T.; Peter, A.; Klein, R.; Hörber, S. Antiphospholipid Antibody Testing in a Maximum Care Hospital: Method-Dependent Differences. J. Clin. Med. 2024, 13, 4528. https://doi.org/10.3390/jcm13154528
Kocijancic M, Goj T, Peter A, Klein R, Hörber S. Antiphospholipid Antibody Testing in a Maximum Care Hospital: Method-Dependent Differences. Journal of Clinical Medicine. 2024; 13(15):4528. https://doi.org/10.3390/jcm13154528
Chicago/Turabian StyleKocijancic, Marija, Thomas Goj, Andreas Peter, Reinhild Klein, and Sebastian Hörber. 2024. "Antiphospholipid Antibody Testing in a Maximum Care Hospital: Method-Dependent Differences" Journal of Clinical Medicine 13, no. 15: 4528. https://doi.org/10.3390/jcm13154528