Venient Fx Inflammatory Response Comprehensive

Test Description
Venient Fx Inflammatory Response Comprehensive is a ground-breaking blood-based screening test that provides extensive information about the systemic inflammatory response and status of autoimmune activity. 

This is an Evidence-Based Laboratory Medicine (EBLM) test developed not only in compliance with the American College of Rheumatology (ACR) guidelines, but also incorporating the latest scientific findings. Thanks to our proprietary machine learning (ML) algorithms, this test is able to detect a wide range of inflammatory and autoimmune disorders, such as Sjögren's disease, rheumatoid arthritis, mixed connective tissue disease, scleroderma or systemic lupus erythematosus, among others. 

United States Preventative Services Task Force (USPSTF) screening recommendations
Currently, there is no USPSTF (United States Preventative Services Task Force) screening recommendation for inflammatory and autoimmune diseases. However, Kience Inc. recommends our laboratory-developed test (LDT) Venient Fx Inflammatory Response Comprehensive to target patients with clinical symptoms or suspicion of: rheumatoid arthritis (RA), Sjögren’s disease, reactive arthritis, arthritis due to systemic lupus erythematosus (SLE) and psoriasis, or infectious arthritis, among others.

Intended Use
The intended population of Venient Fx Inflammatory Response Comprehensive are patients with clinical symptoms or suspicion of: rheumatoid arthritis (RA), Sjögren’s disease reactive arthritis, arthritis due to systemic lupus erythematosus (SLE) and psoriasis, or infectious arthritis, among others.

Sample Clinical Vignette
A 40-year-old female presented to the clinic for medical evaluation after a two year history of pain, edema and wrist redness. Her knees have morning stiffness and some mobility limitations. Physical exam revealed arthritis, swelling and Heberden's nodes in the distal interphalangeal joints with ulnar deviation. Her left knee and right wrist were swollen as well. Serum is submitted to detect for autoimmune inflammatory connective tissue-related diseases, such as rheumatoid arthritis.

Required Laboratory Determinations
Hemogram —Red Blood Cell Count, Hemoglobin, Hematocrit, Erythrocyte Sedimentation Rate (ESR)—; Red Blood Cell Indices —Mean Corpuscular Volume (MCV), Mean Corpuscular Hemoglobin (MCH), Mean Corpuscular Hemoglobin Concentration (MCHC), Red Cell Blood Distribution Width (RDW)—; Leukocyte Count —Total Leukocytes Absolute, Total Neutrophil Absolute, Total Lymphocyte Absolute, Total Monocyte Absolute, Total Eosinophil Absolute, Total Basophil Absolute—; Platelets —Total Platelet Count, Mean Platelet Volume (MPV), Platelet Distribution Width (PDW)—; Serum Antibodies —Antinuclear Antibody (ANA), Cyclic Citrullinated Peptides Antibodies (Anti-CCP), Anti-Histidyl Transfer RNA Synthase Antibodies (Anti-Jo-1), Anti-Ribonucleoprotein Antibodies (Anti-RNP), Scleroderma Antibodies (Anti-Scl-70), Smith Antibodies (Anti-Sm), Sjögren Syndrome A Antibodies (Anti-SS-A), Sjögren Syndrome B Antibodies (Anti-SS-B), Rheumatoid Factor (RF)—; Serum Proteins —High Sensitivity C-Reactive Protein (hs-CRP), Ferritin—; Serum Hepatic Enzymes —Creatine Kinase (CK)—.