A novel, accurate, and non-invasive liquid biopsy test to measure cellular immune responses as a tool to diagnose early-stage lung cancer: a clinical trials study.

INTRODUCTION: Lung cancer remains the leading cause of death from cancer, worldwide. Developing early detection diagnostic methods, especially non-invasive methods, is a critical component to raising the overall survival rate and prognosis for lung cancer. The purpose of this study is to evaluate two protocols of a novel in vitro cellular immune response test to detect lung cancer. The test specifically quantifies the glycolysis metabolism pathway, which is a biomarker for the activation level of immune cells. It summarizes the results of two clinical trials, where each deploys a different protocol's version of this test for the detection of lung cancer. In the later clinical trial, an improved test protocol is applied. METHOD: The test platform is based on changes in the metabolic pathways of the immune cells following their activation by antigenic stimuli associated with Lung cancer. Peripheral Blood Mononuclear Cells are loaded on a multiwell plate together with various lung tumor associated antigens and a fluorescent probe that exhibits a pH-dependent absorption shift. The acidification process in the extracellular fluid is monitored by a commercial fluorescence plate reader device in continuous reading for 3 h at 37 °C to document the fluorescent signal received from each well. RESULTS: In the later clinical trial, an improved test protocol was applied and resulted in increased test accuracy. Specificity of the test increased to 94.0% and test sensitivity increased to 97.3% in lung cancer stage I, by using the improved protocol. CONCLUSION: The improved protocol of the novel cellular immune metabolic response based test detects stage I and stage II of lung cancer with high specificity and sensitivity, with low material costs and fast results.

A multicenter study evaluating the flowcytometric-based kit for semen analysis.

OBJECTIVE: To evaluate the precision and accuracy of a flowcytometric-based semen analysis kit and its application in four fertility centers, as compared with routine microscopic evaluation. DESIGN: A prospective comparative study. SETTING: Four fertility centers, located in Israel and the United States. PATIENT(S): Patients referred to fertility clinic for sperm evaluation. INTERVENTION(S): The precision of semen analysis by both methods was evaluated by inter- and intra-technician studies. The accuracy of the sperm counts obtained was assessed by counting a diluted sample and comparing the obtained results with the expected results according to the dilution factor. MAIN OUTCOME MEASURE(S): Sperm count, morphology, motility, viability, white cell count, antisperm antibodies. RESULT(S): The flowcytometric-based kit for semen analysis is more precise and accurate than the manual routine method. Smaller coefficient of variance (CV%) with results were obtained by the flowcytometric-based kit for all semen parameters as compared with the routine manual methods. Sperm density values determined by the flowcytometric-based kit correlated better with the dilution factor. The agreement rates between the flowcytometric and manual methods are sperm count 90%, motility 82%, vitality 70%, round cell counts 78%, and sperm bound antibodies 100%. CONCLUSION(S): Semen analysis by flowcytometric-based kit is advantageous because of improved precision and accuracy compared with the routine method. It provides similar clinical information to that obtained by routine method for sperm count, motility, and antisperm antibodies, and more accurate results for round cell counts (labeled all subclasses) and vitality.

A malaria merozoite surface protein (MSP1)-structure, processing and function

Merozoite surface protein-1 (MSP-1, also referred to as P195, PMMSA or MSA 1) is one of the most studied of all malaria proteins. The proteins. The protein is found in all malaria species investigated and structural studies on the gene indicate that parts of the molecule are well-conserved. Studies on Plasmodium falciparum have shown that the protein is in a processed form on the merozoite surface, a result of proteolytic cleavage of the large percursor molecule. Recent studies have identified some of these cleavage sites. During invasion of the new red cell most of the MSP1 molecule is shed from the parasite surface except for a small C-terminal fragment which can be detected in ring stages. Analysis of the structure of this fragment suggests that it contains two growth factor-like domains that may have a functional role