[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"American Laboratory Products Company\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":82},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,43],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":4,"eligibilityCriteria":14,"healthyVolunteers":15,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":22,"conditions":23,"keywords":26,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100578378","alpco-calprotectin-clia-assay---measurement-of-calprotectin-levels-in-human-stool-100578378",false,"NCT06810518","ALPCO Calprotectin CLIA Assay - Measurement of Calprotectin Levels in Human Stool","Inclusion criteria:\n\n* Male or female, ≥22 years of age (adults)\n* Suspected inflammatory bowel disease or irritable bowel syndrome with symptoms such as abdominal pain, diarrhea, altered appetite, weight loss, or anemia\n* Able to provide a sample according to the sampling protocol within 72-24 hours prior to the scheduled diagnostic endoscopy or 3-30 days after the colonoscopy.\n* Able to understand the study and the tasks required and sign the ICF\n\nExclusion criteria:\n\n* Unable or unwilling to provide a stool specimen\n* Known active intestinal cancer or in remission with abnormal levels (per physician assessment)\n* Known active intestinal infection or history of treated intestinal infection with persistent abnormal levels (per physician assessment)\n* IBD patients receiving chemotherapy or systemic immunosuppressive drugs without completing an 8-week washout period\n* IBD patients who have previously diagnosed IBD managed with immunomodulators, 5-ASA or biologic therapies without completing an 8-week washout period for biologics and immunomodulators or 4 weeks for 5-ASA\n* IBD patients who have previously been diagnosed with IBD and have undergone a surgical resection or diversion procedure.\n* Known upper Gl disease such as esophagitis or gastritis that might influence the study test's ability to detect intestinal inflammatory disease\n* Have taken NSAIDS (including aspirin) on 7 or more days during the 2 weeks before providing the sample\n* Samples are not collected according to sampling protocol.\n* Any condition that in the opinion of the investigator should preclude participation in the study.\n\nUsing an IRB approved consent form, all study participants will be advised of study requirements and potential risks associated with study participation.",true,"ALL","22 Years",{"count":19,"type":20},220,"ESTIMATED","OBSERVATIONAL","The ALPCO Calprotectin CLIA is an in vitro diagnostic test intended to quantitatively measure concentrations of fecal calprotectin in human stool samples. Calprotectin is a protein biomarker of mucosal inflammation. Measurement of calprotectin can aid in the diagnosis of Inflammatory Bowel Diseases (IBD), specifically Crohn's Disease (CD) and Ulcerative Colitis (UC), as well as aid in the differentiation of IBD from Irritable Bowel Syndrome (IBS) when used in conjunction with other diagnostic testing and the total clinical picture. The goal of the study is to generate data to support positive and negative predictive value of the ALPCO Calprotectin assay in patients with signs and symptoms of IBS or IBD.",[24,25],"Inflammatory Bowel Disease (Crohn's Disease and Ulcerative Colitis)","Inflammatory Bowel Syndrome",[27,28,29],"calprotectin","IBD","IBS","RECRUITING","2026-04-27",{"date":33,"type":34},"2026-04-28","ACTUAL",{"date":36,"type":34},"2025-03-25",{"date":38,"type":20},"2026-12-31",{"name":40,"class":41},"American Laboratory Products Company","INDUSTRY",3,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":4,"eligibilityCriteria":49,"healthyVolunteers":15,"sex":16,"minAge":50,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":21,"phases":4,"briefSummary":53,"conditions":54,"keywords":62,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},"100599849","this-study-evaluates-the-alpco-syphilis-t-and-syphilis-nt-clia-kits-for-detecting-syphilis-antibodies-in-serum-and-plasma-samples-from-at-risk-hiv-positive-pregnant-and-healthy-individuals-will-assess-assay-performance-versus-established-comparator-tests-100599849","NCT07089836","This Study Evaluates the ALPCO Syphilis-T and Syphilis-NT CLIA Kits for Detecting Syphilis Antibodies in Serum and Plasma. Samples From At-risk, HIV-positive, Pregnant, and Healthy Individuals Will Assess Assay Performance Versus Established Comparator Tests.","ALPCO Syphilis-T and Syphilis-NT CLIA Kits: Detection of Antibodies to Treponema Pallidum and Against Lipoidal Antigens in Human Serum and Plasma","Inclusion Criteria:\n\n* Male, Female, or Other(s)\n* Patients undergoing routine syphilis testing (asymptomatic at risk, suspected with symptoms, prior history of syphilis, high risk for syphilis) or previously diagnosed with syphilis through a test performed in an accredited laboratory.\n* Participants must be willing to provide the required blood samples for the clinical study, in addition to any samples requested by their physician.\n* Pregnant individuals and children (under 22): 1 clinical study tube of blood.\n* All other participants (excluding pregnant individuals and children): 2 clinical study tubes of blood.\n* Participants must be able and willing to sign the informed consent form (ICF).\n* Participants aged 13 to 17 will be asked to sign an assent form. Written parental or guardian consent will also be required prior to enrollment. The assent form will use age-appropriate language and be reviewed with the participant before any procedures.\n\nExclusion Criteria:\n\n* Patients currently being treated with antibiotics or completed a course of antibiotics within the past 30 days\n* Patients with pre-existing conditions that would make blood collection difficult or harmful\n* If the samples are not collected in strict accordance with the established sampling protocol, as determined by the study team.\n* Any medical, psychological, or social condition that, in the judgment of the investigator, could interfere with the participant's ability to comply with study requirements, or pose a risk to their safety, or compromise the integrity of the study.","13 Years",{"count":52,"type":20},1000,"This study will evaluate the clinical performance of two investigational diagnostic kits developed by ALPCO: the Syphilis-T CLIA Kit and the Syphilis-NT CLIA Kit. These kits are designed to detect antibodies to Treponema pallidum and non-treponemal lipoidal antigens, respectively, in human serum and plasma using the automated KleeYa platform. The study will collect and analyze blood samples from individuals suspected of having syphilis, those at high risk, HIV-positive patients, pregnant individuals, and healthy controls. The aim is to determine the kits' Positive Percent Agreement (PPA) and Negative Percent Agreement (NPA) compared to established reference assays.",[55,56,57,58,59,60,61],"Treponema Pallidum","Treponema Pallidum Infection","Syphilis Infection","Serum","Plasma","Blooddraw","Sexually Transmitted Infection (STI)",[63,64,65,66,67,68,69,70,71,72],"Non Treponema","Treponema","Syphilis","Sample Collection","Treponema pallidum","Non-treponemal test","Chemiluminescent immunoassay","HIV-positive","Pregnant women","Blood sample collection","2026-02-09",{"date":75,"type":34},"2026-02-11",{"date":77,"type":34},"2025-12-10",{"date":79,"type":20},"2026-07",{"name":40,"class":41},6,""]