*This should be used as a guide for identification purposes only. The average hemoglobin level for men is 16 g/dL and women is 14 g/dL. However, the definition of "normal" varies from person to person. Therefore, your healthcare provider will determine the level at which treatment would be appropriate for you.

What will BioSafe's Anemia Meter tell me?

Since a lower than normal hemoglobin level indicates anemia, anemia can be detected by testing the blood. The BioSafe Anemia Meter will show you your hemoglobin level; an important first step in determining whether you may have anemia.

The anemia meter is the first test device that can be used in the comfort of your home to check your hemoglobin level. It is as accurate and reliable as a lab test in measuring hemoglobin. It also gives you a  convenient way to show your results to your doctor, since your doctor is the only one who can diagnose a condition of anemia, and prescribe an appropriate treatment plan.

What do I do next?

Read through the instructions. Familiarize yourself with all the steps before you begin, to make the process quick and easy. If your result shows that your hemoglobin is in the "normal" range for your gender, write down your result for future reference and discard the Anemia Meter. If your result shows that you are "out of normal range" and possibly anemic, make an appointment with your doctor to discuss your result and what form of treatment would be appropriate for you. Your Anemia Meter result is stable for 30 days.

Performace Characteristics:

The performance characteristics of the Anemia Meter have been established in controlled clinical trials using volunteer adult subjects, and have been evaluated by the US Food and Drug Administration.

Claims:

• Quick and Easy-to-Use as evaluated in controlled clinical studies.

• Self-Testing for hemoglobin may assist in the screening of patients at risk for anemia

• As accurate as a laboratory based test for hemoglobin.

• Safe blood collection system, as evaluated during clinical trials, and in clinical use in several home-based blood tests from BioSafe.

Accuracy:

The Anemia Meter was evaluated through a two-part process. Blood samples were first collected and tested by volunteer subjects themselves and then again within 30 minutes by a professional healthcare worker. These hemoglobin results were compared against a hemoglobin result obtained with a laboratory-based method. comparisons between methods show that the Anemia Meter has an accuracy of over 96% and is more than 97% specific for identifying anemia as identified by a low hemoglobin level. Both the accuracy and specific of the Anemia Meter compare favorably with laboratory-based tests.

Comparisons between the Anemia Meter to paired venous samples tested on the Abbott Cell Dyn Laboratory analyzer showed a coefficient of 0.929, indicating a high degree of correlation, and a strong agreement between these methods. Comparisons between the BioSafe Anemia Meter and the HemoCue instrument using capillary blood showed a coefficient of 0.735, which indicates that the agreement between these methods is not as strong as was observed between the Anemia Meter and the Cell Dyn.

In side-by-side testing between volunteers performing a self-test and devices tested by medical professionals, the hemoglobin results agreed with a correlation coefficient of 0.945, demonstrating that untrained users following the directional insert were able to obtain results as accurate as those determined by a trained medical professional.

Reliability:

Laboratory studies were conducted to determine test reliablity by measuring the same blood sample several times under the same conditions. Results showed that hemoglobin concentration varied by less than 6.0% when the same person's blood was tested on 5 devices.

When the same sample was tested on 4 different days, the variations were again shown to be less than 6.0% Both precision studies compared favorably with laboratory-based tests.

Cautions and Limitations:

Failure to follow all instructions may affect the accuracy of the test results. Use device within 30 minutes of removing from the foil pouch. For in vitro diagnostic only. Not intended for individuals under 18 years of age. Do not use this product if your have blood clotting disorder (such as hemophilia) or are taking prescription medications that thin your blood (such as anti-coagulants) unless otherwise directed by your doctor or other healthcare professional. Store between 50*F (10*C) and 100*F (37*C). Avoid freezing. Intended for indoor use in non-condensing humidity. Keep out of reach of children. Results less than 8 g/dL and greater than 15 g/dL need to be confirmed by professional laboratory methods to determine the actual hemoglobin level.

References:

1. Ashwood, R. Edward and Burtis, A. Carl. Tietz Textbook of Clinical Chemistry. 1996
2. Pagana KD, Pagana TJ, Blood Studies. In: Mosby's Manual of Diagnostic and Laboratory tests. Philadelphia, PA: Mosby, Inc; 1998.

 

 

 

 

 

 

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