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Currently there are no clinical guidelines for the diagnosis of APS; the only available guidance is the classification criteria, which are primarily intended for clinical research. The classification criteria for APS require the identification of at least one clinical and one laboratory criterion.3
Vascular thrombosis. One or more clinical episodes of arterial, venous, or small-vessel thrombosis in any tissue or organ. Thrombosis must be confirmed by objective validated criteria. For histopathological confirmation, thrombosis should be present without significant evidence of inflammation in the vessel wall.
Pregnancy morbidity. One or more unexplained deaths of a morphologically normal fetus at or beyond the 10th week of gestation, OR one or more premature births of a morphologically normal neonate before the 34th week of gestation because of:
While thrombosis and fetal and obstetric complications are the most recognizable clinical signs of APS, and included in the classification criteria, there is growing evidence of APS presenting with other symptoms.
Some symptoms that should prompt you to consider diagnostic testing for APS include heart valve lesions, headaches, epilepsy, livedo reticularis, and other autoimmune conditions.3
The hallmark serological testing result that defines APS is the presence of persistent antiphospholipid antibodies (aPL). To be classified as APS, international consensus of the classification criteria state that a patient must have elevated titers of one of the following antiphospholipid antibody (aPL):3,5
These antiphospholipid antibodies are considered to be diagnostic markers and pathogenic drivers of APS.6 The classification criteria for APS states a patient who fulfills clinical criteria can be classified as APS dependent when the patient exhibits a persistently positive aPL result on two or more occasions at least 12 weeks apart.3,7
Deep vein thrombosis, sometimes accompanied by pulmonary embolism, is the most frequently reported manifestation in this syndrome (about 39 percent). Cerebrovascular accidents—either stroke (20 percent) or transient ischemic attacks (11 percent)—are the most common arterial thrombotic manifestations.
Adding diagnostic testing to aid in a differential diagnosis has been shown to increase confidence in diagnosis to 90 percent.i,ii Conventionally, a diagnosis of allergic or autoimmune disease relies on the case history and a physical examination. However, adding diagnostic testing to aid in a differential diagnosis has been shown to increase confidence in diagnosis.i,ii Diagnostic testing can also help to improve the patient’s quality of life and productivity, reduce costs associated with absenteeism, and optimize use of medication, in addition to decreasing unscheduled healthcare visits.iii,iv
i. Duran-Tauleria E, Vignati G, Guedan MJ, et al. The utility of specific immunoglobulin E measurements in primary care. Allergy. 2004;59 (Suppl78):35-41.
ii. NiggemannB, Nilsson M, Friedrichs F. Paediatric allergy diagnosis in primary care is improved by in vitro allergen specific IgE testing. Pediatr Allergy Immunol. 2008;19:325-331
iii. Welsh N, et al. The Benefits of Specific Immunoglobulin E Testing in the Primary Care Setting. J Am Pharm Assoc. 2006;46:627.
iv. Szeinbach SL, Williams B, Muntendam P, et al. Identification of allergic disease among users of antihistamines. J Manag Care Pharm. 2004; 10 (3): 234-238
Antiphospholipid syndrome (APS) is an acquired autoimmune condition that affects young patients, primarily women, in the most productive years of their lives, and the consequences of organic or tissue damage involve a decrease in health-related quality of life (HRQoL).9
APS is under-recognized and underdiagnosed and can have devastating results if untreated, mainly due to uncontrolled thrombosis. Treatment can reduce mortality and morbidity in young people who often present with stroke, myocardial infarction, and deep vein thrombosis.10
There are no clinical practice guidelines covering all aspects of the diagnosis and treatment of APS; the available guidance is the classification criteria that are primarily intended for clinical research. The classification criteria for APS require the identification of at least one clinical and one laboratory criterion.10
With no formal clinical guidelines in place in the United States, diagnosis and treatment of APS is largely based on consensus and expert opinion.11