Exim Group LLC is an Authorized Agent for RxGenesis, the international distributor for MedMira Rapid HIV Tests, for sales to International Agencies and in India  and Thailand.

MiraWell Rapid HIV Tests Overview

HIV Type Detection. HIV 1& 2 (subtypes M, O)

Multi-Purpose Rapid Test. MiraWell Rapid Tests can be used in single or batch testing through to employee exposure. Provides Quick Results - Test completed in 3 minutes and easy to read.

Visual Interpretation. MiraWell Flow-Through tests use the same test components as ELISA and are visually interpreted for easy result reading. Positive results may be confirmed using ELISA or Western Blot traditional assays

International Approval. FDA US, SFDA China, Health Canada, Peru, CE pending.

Technology. All of MedMira's products are based on the same unique flow-through membrane technology, which relies on highly specific antigen-antibody reactions allowing for the detection of disease-specific markers in clinical specimens. In our rapid tests, a special membrane is coated with disease-specific antigens or antibodies to capture the corresponding marker in the test sample, thus allowing for the detection of the disease. The simple testing procedure involves placing a drop of the test sample on the coated test membrane and allowing it to flow through the membrane. If the sample contains the target antibodies or antigens, they are captured on the test membrane and result in a highly specific antigen-antibody complex. The test result is visualized at a colored end point through a reaction with a proprietary detection agent and can be interpreted immediately.

Where and when to use. To perform in vitro diagnostic & screening in Hospitals, Medical Clinics, MDs Offices, Labs, Medical Diagnostic Settings and Homes.

Ready To Use. Contains all reagents and materials required to perform the assay. Do not have to purchase any additional materials.

Doesn’t Require Refrigeration. Stored anywhere temperature between 2–30 degrees C.

Doesn’t Require Special Equipment. Whole blood individual tests are self-contained and have all test items required for testing.  A standard centrifuge used for serum/plasma version of tests.

Multiple Formats, Adaptable to Needs of User

- Format A (serum/plasma). Used in MDs’ office and hospitals where a centrifuge is available.
- Format B (whole blood). Used in hospital, MDs office where no centrifuge is available or required.
- Format C (whole blood, serum/plasma). Used in institutions or labs where multiple testing is performed and where a centrifuge may or may not be available.
- MiraCare OTC (whole blood, serum/plasma). Sold in retail outlets. Centrifuge may or may not be available. May be for home use. Individually packaged, with complete set of test items.

Technical Specifications.
Tests can be conducted using serum, plasma or whole blood depending on where the test is being conducted.
                Sensitivity Specificity
Serum             99.8%     100%
Plasma            99.8%       99.8%
Whole Blood     99.8%     100%

Quality Assured. All MiraWell and MiraCare tests are manufactured in a US FDA approved GMP & ISO9001:2002 certified facility. MedMira manufactures all tests under the ISO: 13485 Medical Devices Standards for Canada. All products are manufactured and tested in Canada.

Weight of Evidence (Studies):     US CDC               Ranked # 1
                                                   South Africa NIDC             # 1
                                                   Curacao                           # 1
                                                   China CDC                       # 1
                                                   Spanish Ministry Health    # 1

Packaging MiraWell HIV: Other than the OTC individual test, each Kit contains 50 tests.

Shelf-Life: 1 year

Please contact Exim Group LLC for additional information and pricing.

Disclaimer: Sale of MedMira's products is controlled by the governing regulatory agencies in specific regions. Certain statements in this article do not apply to all MedMira products. Specifically, in a growing number of countries MedMira's products are allowed and/or approved for sale in medical settings, point-of-care, and for home use. Details on each product's situation can be obtained from Exim Group LLC. Due to each country's requirements, MedMira Rapid HIV Tests are sold in the USA under the trade name Reveal, and under the trade name MiraWell in other countries.
 

Copyright © 2003 - 2007 Exim Group LLC
Last modified: 05/08/07