Diagnostic Products For Home Use
No-step Strep A Test
Novamed’s No-step Strep A Test REF: R-6009 is a unique, instant individual immunochromatographic in-vitro diagnostic assay for the direct detection of beta-hemolytic Group A Streptococcus antigen in throat swab specimens to aid in the diagnosis of streptococcal pharyngitis.
Novamed’s No-step Strep A Test device is based on the traditional platform of streptococcal antigen extraction and lateral flow assay, but the reagents and extraction procedure are built-in into a plastic casing and the process runs automatically upon the pressing of the button by the user.
Novamed’s No-step Strep A Test device utilizes Novamed’s proprietary technology which facilitates minimal user involvement in the testing process.
For ease, simplicity of procedure and rapidity of results, the No-step Strep A Test is recognized as a true Point-of-Care Test, allowing to correctly diagnose the streptococcal pharyngitis directly in doctors' offices, polyclinics and at home. This can prevent antibiotic overuse and mishandling of the regular test.
SensAheart One Step Assay
SensAheart is a new, super-sensitive rapid immunoassay for the early diagnosis of acute myocardial infarction (AMI) in pre-hospital conditions.
SensAheart is a simple, easy-to-use rapid test that does not require any additional equipment and specially trained personnel to diagnose AMI at the earliest stage of the disease.
The uniqueness of the SensAheart is in the patent technology of using a combination of specific antibodies in a single test to detect one or both cardiac biomarkers (hFABP and Troponin I) simultaneously, in one drop of capillary blood, in the 30-th minute from onset of the disease.
A positive result, due to the additive and summarized reaction of specific antibodies to the presence of one or both biomarkers in the blood, is expressed by one color band, providing a YES / NO qualitative result within 15 minutes.
• At early chest pain / onset of a heart attack, when the concentration of cTnI in the blood just begins to rise, a positive result of the SensAheart is provided solely due to increased hFABP concentration.
• In the interim stage, when hFABP starts to decay, but cTnI is still below the cut-off value, a positive result of the SensAheart is provided by the additive effect of the presence of both markers.
• At the end of 24 hours after the onset of a heart attack, when the hFABP concentration reduces under the cut-off value, a positive test result is provided solely by increased cTnI concentration.
A comparative clinical study conducted in Hadassah Ein Kerem and Hadassah Mount Scopus hospitals in Jerusalem in 2013-2018 used 255 patients admitted with a suspected AMI or ACS. The results of Novamed SensAheart were compared to the hospital's Elecsys® Troponin T Roche automatic system’s final diagnosis based on discharge. The sensitivity level of SensAheart test (80.4%) was considerably higher for early comers than the hospital's Elecsys® Troponin T Roche automatic system (63.8%).
Novamed’s SensAheart One-Step Assay can be easily deployed at the bedside, at the point of patient care, at pharmacies, in physicians’ office, in triage rooms, emergency service areas, ambulances or designated lab areas or by the patient himself.
Novamed’s SensAheart One-Step Assay is available in two different formats: Kit packaging contains 20 SensAheart tests (REF: R-6503 -20) or individual packaging of 2 SensAheart tests (R-6503-2).