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Clozapine Assay Kit

Runs on Automated Clinical Chemistry Analysers

Clozapine is the most effective antipsychotic drug for reducing positive symptoms, hospital admissions, and all-cause mortality in patients with schizophrenia.1 Saladax’s test offers clozapine blood levels within hours instead of days.

Assay Highlights

Intended Use

The MyCare Psychiatry Clozapine Assay Kit is intended for the in vitro quantitative measurement of clozapine in human serum and plasma using automated clinical chemistry analysers. Measurements obtained are used for monitoring patient adherence to clozapine therapy to help ensure appropriate treatment.

View Product Performance & Expected Values

Rapid, accurate, easy to perform diagnostic test

Ready for use on automated analyzers already present in clinical labs

<30 minutes to generate a result after receipt in lab

Testing can be performed STAT

Testing can be offered 24 x 7

Cost Effective

CE Marked

Clozapine is the most effective antipsychotic for reducing positive symptoms, hospital admissions, and all-cause mortality in patients with schizophrenia.1


Obtaining timely clozapine drug levels is a significant barrier to clozapine use.2


Drug level monitoring may reduce the risk of relapse or recurrence by increasing the doctor’s awareness of the patient’s adherence to the medication.3

Readily available methods for rapidly measuring antipsychotic levels in clinical settings are needed for clinicians to make reliable assessments.4


TDM-based prevention of atypical antipsychotic overdosing is, for the majority of patients, a matter of the patient’s quality of life rather than of safety.3


Clinical guidelines strongly recommend routine monitoring of clozapine drug levels in blood.3,5

1. Siskind, et al. 2020. J Psychiatry Neuroscience; 45(4):200061
2. Kelly, et al. 2018. Psychiatric Services; 69:224-227
3. Hiemke, et al. 2018. Consensus Guidelines for Therapeutic Pharmacopsychiatry; 51: 9–62
4. Lopez, et al. 2017. J Clin Psychopharmacology; 37(3): 310-314
5. The Maudsley Prescribing Guidelines in Psychiatry. 2021. John Wiley & Sons, Ltd.

MyCare Psychiatry Clozapine Assay Kit

Product Performance

Sample N Mean Repeatability1 Within-Laboratory1
(ng/mL) CV CV
Control 1 80 156 3.6% 5.7%
Control 2 80 474 2.4% 4.8%
Control 3 80 945 2.9% 5.2%
Clinical 1 80 148 3.6% 6.6%
Clinical 2 80 338 2.2% 4.2%
Clinical 3 80 577 2.6% 4.3%
Clinical 4 80 926 3.6% 5.1%

1Verified according to CLSI Guideline EP05-A3

Expected Values

As for any laboratory test, the clinical context should be taken into consideration when interpreting clozapine results. Compare assay results to results expected based on previous measurements, subject’s baseline, suggested therapeutic range, or values expected for the individual. Clozapine has a recommended therapeutic reference range of 350 – 600 ng/mL. Guidelines strongly recommend therapeutic drug monitoring for clozapine.1

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