Diagnostic Tests: What Physicians Need to Know

The Diagnostic Tests department uses a structured approach to provide concise reviews of new diagnostic tests, including discussions of test accuracy, benefits, harms, cost, and clinical bottom line.

Mar 1, 2021 Issue
Serum Lactate Testing to Predict Mortality in Patients with Sepsis
Management of patients with sepsis is challenging and mortality is high. Early diagnosis and prompt initiation of therapy are essential. Higher lactate levels correlate with increased risk of mortality, particularly with lactate levels greater than 4.0 mmol per L and in the setting of hypotension.

Feb 1, 2021 Issue
QuantiFERON-TB Gold+ for the Diagnosis of Mycobacterium tuberculosis Infection
QuantiFERON-TB Gold+ testing for the diagnosis of active or latent TB is easily interpreted and more specific than tuberculin skin testing in BCG-vaccinated populations. In environments with an easily accessible laboratory, it may be a preferred option for diagnosing latent TB.

Jan 1, 2021 Issue
CT Colonography for Colorectal Cancer Screening
Computed tomography colonography performs well for colorectal cancer screening. Long-term studies are needed to demonstrate its impact on patient morbidity and mortality, as well as to determine the risks, benefits, and costs.

Nov 1, 2020 Issue
KardiaMobile for ECG Monitoring and Arrhythmia Diagnosis
KardiaMobile is a mobile single lead ECG device that is FDA approved for detection of atrial fibrillation, bradycardia, and tachycardia.

Sep 1, 2020 Issue
Placental Alpha Macroglobulin-1 (PartoSure) Immunoassay to Assess the Risk of Spontaneous Preterm Birth
Placental alpha macroglobulin-1 (PartoSure) is an immunoassay that measures the presence of placental alpha macroglobulin-1 (PAMG-1). PartoSure is used to assess the risk of spontaneous preterm birth and may be a useful adjunct to determine which patients with threatened preterm labor might benefit from corticosteroid administration to improve neonatal outcomes.

Jul 1, 2020 Issue
PAULA’s Test for Lung Cancer Screening
Because of insufficient evidence of benefit, no recommendations can be made regarding PAULA's test. Prospective cohort studies of a screening population and randomized controlled trials comparing cancer mortality outcomes using PAULA's test vs. low-dose CT and no screening are needed before the test can be recommended as a screening option.

May 1, 2020 Issue
IBSchek for Irritable Bowel Syndrome
IBSchek is a blood test marketed to assist in the diagnosis of irritable bowel syndrome with predominant diarrhea (IBS-D) or with mixed bowel habits (IBS-M) in adults.

Mar 1, 2020 Issue
IDx-DR for Diabetic Retinopathy Screening
IDx-DR is a reliable screening tool used to diagnose diabetic retinopathy in the primary care office and may reduce barriers to screening and improve gaps in eye care for those with diabetes.

Jan 1, 2020 Issue
PLAC Test for Lp-PLA2 Activity to Predict Coronary Heart Disease
The PLAC test is a blood test used to measure serum activity of lipoprotein-associated phospholipase A2 (Lp-PLA2), an enzyme that breaks down oxidized low-density lipoprotein in the vascular wall.

Nov 1, 2019 Issue
Allopurinol Hypersensitivity Assay HLA-B*58:01 Genotyping
The allopurinol hypersensitivity assay, or HLA-B*58:01 test, is a blood test to detect the presence of a human leukocyte antigen B (HLA-B) genetic variant that increases the risk of life-threatening, severe cutaneous adverse reactions in patients taking allopurinol.

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