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New Lithium In-Office Test Receives CLIA Waiver
Lithium is as important to a person with bipolar disorder as insulin is to someone with diabetes. Patients who stop taking the medication are just as likely to fall back into a manic or depressive episode
as patients who have neverbeen treated. Therapeutic
monitoring of lithium blood levels is a necessary part of
the standard approach to the prescription of this drug.
Unfortunately, the average prescriber and patient would
prefer to employ therapeutic monitoring as little as
necessary. The reasons for this are found in the
burden of blood monitoring.

From the physician's perspective the burdens include:

1. ordering testing
2. ensuring that a patient follows through for venipunture
3. communicating with the centralized laboratory that analysis has been completed
4. charting the results. In a recent survey, 65% of psychiatrists reported that they would test more patients if a rapid, point-of-care test were available (ReliaLAB, 2002). Increased tests would result from convenience and the prescriber's interest in monitoring compliance.

The burdens to the patient include:

1. The patient's time traveling to a laboratory
2. a family member's or caregiver's traveling time when accompanying the patients
3. transportation costs. The resulting lag time between the venipuncture and the test results impacts on the continuity and quality of treatment. Given the variation in travel modalities, distance to the laboratory, time spent waiting for and receiving a blood draw, patient challenges are understandable.

An Unprecedented Advancement in Psychiatry
Until now, psychiatrists and their patients have had to rely on time-consuming and inconvenient laboratories for the monitoring of lithium blood levels. The new Lithium Test System can now provide instant and accurate blood levels right in the psychiatrist's office, bringing a finer level of control to patient therapy. While Point-of-Care testing is new to psychiatry, it is not a new approach in medicine. Just as instant glucose meters enabled increased levels of confidence and control in the treatment of diabetes, FDA clearance of the new Lithium Test System marks the beginning of an age when psychiatrists too can use rapid diagnostic tools in their own practice of medicine. Instead of an uncomfortable venous blood draw with a needle that is used in outside laboratories, the new Lithium Test System requires just a few drops of the patient's blood from a fingerstick. The availability of instant monitoring can help the psychiatrist manage against both side effects and noncompliance. This is a significant advancement in treatment quality for patients that depend upon lithium for the management of their psychiatric conditions.

Confidence and Control
The new Lithium Test System has been proven in rigorously-designed clinical trials to provide lithium levels as accurately as traditional laboratories. Now psychiatrists and patients alike can have confidence that therapeutic levels of lithium are maintained.

Also, because the new Lithium Test System is designed for use right in the office, hospital, or clinic where a patient sees their doctor, a new level of control can be realized in therapy with lithium. Psychiatrists can now instantly monitor lithium to:

• Detect or prevent unwanted side-effects
• Maintain a therapeutic lithium range
• Verify patient compliance

Ease of Use
The system consists of 3 key components: a blood cell separator, a lithium reagent, and the electronic analyzer. The blood cell separator prepares a patient's blood sample for analysis. The reagent that is used reacts with lithium in the blood sample to form a color. The analyzer interprets the color, and directly reports lithium concentrations on the digital display of the device. The test is quick, simple and convenient to use. Just a drop of blood from a fingerstick is all that is required to produce laboratory like results. The new lithium test is categorized as CLIA Waived and only requires a simple application to obtain a CLIA Certificate of Waiver. The test is easy enough for any member of the staff in an office, clinic or hospital to perform.