Hema Diagnostic Systems (HDS) is a manufacturer of in-vitro medical diagnostic devices for both point of care and laboratory-based tests, primarily for infectious diseases. Established in Miami, Florida on December 1, 2000, HDS is currently headquartered in Miramar, Florida.
Strategically, the Company’s mission has been to develop, manufacture and market a series of diagnostic tests that yields repeatable and reliable test results for an antibody or antigenic response to a specific disease in such samples as whole blood, plasma, or serum. Currently, our product line includes such tests for infectious diseases such as HIV ½, Syphilis, Tuberculosis, Malaria, Hepatitis-B, and Hepatitis-C.
HDS has developed rapid diagnostic assays capable of delivering test results within 10-15 minutes, and requiring a small amount of whole blood usually taken from a finger stick; serum or plasma samples are approved for use when performing the test in a laboratory. HDS has produced and validated multiple diagnostic test strips, each developed for a particular disease and carefully produced following strict ISO 13485, and ISO 9001 standards. Our test strips are assembled into any of the two available delivery devices, the RAPID 1-2-3® HEMA EXPRESS®, and the RAPID 1-2-3® HEMA CASSETTE. Any of these two formats facilitate the rapid and easy use of the diagnostic in the field, clinic or office.
The particular design characteristics of the RAPID 1-2-3® HEMA EXPRESS® sets it apart from all other rapid testing devices currently in the market. These characteristics give HDS a competitive advantage over other rapid diagnostic devices in the following scenarios:
- Fewer steps required when administering the test.
- Requires fewer components. No sample transferring devices such as loops or pipettes are required, lessening the risk of spills or cross-contamination.
- A pre-measured buffer solution pod is provided for each test individually. No need for counting or transferring drops, reducing the error margin.
- Once the sample is applied, and the buffered solution pod properly placed as indicated on the instructions, the EXPRESS device contains the sample, and the buffer solution mix closed inside the device avoiding any possible cross-contamination, or spills.
- The simplicity of use of the EXPRESS devices provides confidence and a feeling of safety to the persons administering the test.
- Requires minimum training by the personnel administering the test to learn the required steps.
- All HDS rapid diagnostic tests are color-coded; this helps the personnel administering the tests to identify the disease they are about to test for by the color on the pouch. Ex.: HIV tests use color code RED on the certain components of the express device, and on the outside of the pouch.
- The pouch illustrates images explaining all steps required to perform the test as well as an explanation of the test result interpretation printed on its back.
The key and outstanding characteristics that surround the EXPRESS device design permits HDS to bring into the market a medical device that is discernibly different from other diagnostics and which is simple to use and available for use with a number of different analytes. The RAPID 1-2-3® HEMA EXPRESS® is a perfect choice.