Rapid Antigen Test, Variant 1 -Nasal (SARS/COV-2/# 09365397043 )

Roche SARS‐CoV‐2 (COVID-19) Rapid Nasal Lateral Flow Diagnostic Antigen Test (Box of 25 Tests) In comparison to the existing Roche SARS-CoV-2 Rapid Antigen Test, the SARS-CoV-2 Rapid Antigen Test Nasal collects the sample from the front area of the nose instead of the nasopharynx, resulting in a simplified, more comfortable and faster testing procedure(1). This testing method can help to reduce overall patient discomfort, particularly in sensitive individuals such as children, elderly people and/or people with disabilities. Besides being less invasive, the test also provides patients with the option to self-collect their nasal sample under the supervision of a healthcare professional. Through reduced physical contact, this method of testing can help to decrease the risk of exposure to the virus for healthcare professionals. Whether the test could also be used without supervision of a healthcare professional will depend on local regulatory requirements. Rapid Point of Care testing for SARS-CoV-2 antigens with results in 15-30 minutes Fast triaging and decision making to help control further virus spreading Support healthcare systems with the strategy to perform extensive testing Highly accurate: 98.6% Specificity / 90.6% Sensitivity Less invasive and more convenient testing Reduced patient discomfort for sensitive individuals such as children or elderly people Simplified and faster testing procedure Supervised self-collection of samples upon preference of tested individuals Increase protection of healthcare workers Reduced risk of coughing and sneezing during specimen collection Supervised self-collection to keep a physical distance between HCP and patient Reduced duration of sampling procedure The SARS-CoV-2 Rapid Antigen Test Nasal is able to quickly and reliably detect specific antigen of SARS-CoV-2 in 15 minutes with a specificity of 98.6 % and a sensitivity of 90.6 % (Ct ≤ 30). At Roche Diagnostics we believe wide accessibility to such high-performance, instrument-free and reliable Point of Care tests can contribute significantly to better managing the ongoing pandemic crisis. In collaboration with our partner, SD Biosensor, Roche is planning on an accelerated distribution in large quantities around the world, responding to the increasing need for testing where it is needed. The following components are included in the kit: Test device (individually in a foil pouch with desiccant) Extraction buffer tube and buffer tube rack Nozzle cap Sterile swab Instruction for Use and Quick Reference Guide Positive and negative controls Technical Specification Brand - Roche Test Sample Type - Nasal Only Detailed Technical Information - Assay format: Lateral flow test / immunochromatographic Instrument: No Testing time: 15-30 minutes Specificity: 98.6% Sensitivity: 90.6% (Ct value ≤ 30) Antigen: N Sample material: Nasal Swab Reagents: mAb anti-COVID19 antibody, mAb anti-Chicken IgY, mAb anti-COVID-19 antibody‑gold conjugate, Purified chicken IgY‑gold conjugate Tested against new variants View Roche's statement in response to new Omicron variant of SARS-CoV-2 (B.1.1.529) CLICK HERE The Roche Antigen Tests have been checked against the new Indian variant including B.1.617.1 and B.1.617.2 and are suitable for detecting these SARS-CoV-2 variants. The tests have also been checked against Kent B.1.1.7 lineage, South Africa B.1.351 and Brazil P.1 lineage. Please contact Wellcare Medical Supplies & Health Care Products Ltd.