FDA-Cleared

Clozapine Assay

Assay Highlights

The Only FDA Cleared Clozapine Test

Clozapine is the most effective antipsychotic drug for reducing positive symptoms, hospital admissions, and all-cause mortality in patients with schizophrenia1. Saladax’s test offers clozapine blood levels within hours instead of days. Testing is performed on automated analyzers already present in clinical laboratories.

Clozapine Product DocumentsAssay Highlights

Intended Use

The MyCare Psychiatry Clozapine Assay Kit is intended for the in vitro quantitative measurement of clozapine in adult human serum using automated clinical chemistry analyzers. Measurements obtained can be used to aid in the management of individuals prescribed clozapine for treatment-resistant schizophrenia. This assay should be used in conjunction with other clinical and laboratory findings and results from this test alone should not be used to make treatment decisions.

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

The only FDA cleared clozapine assay

Clozapine is the most effective antipsychotic drug 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

 

Schizophrenia is one of the top 15 prevalent diseases in the United States, causing chronic disability that affects more than 2.5 million adults, or over 1% of the US population.3

 

The direct annual healthcare costs for schizophrenia in the United States are over $37 billion.4

Patients with schizophrenia have hospital stays that last more than twice as long compared to non-mental health patients (10.4 vs. 4.8 days).5

 

Schizophrenia and other psychotic disorders rank #1 for 7-day and #2 for 30-day hospital readmission rates of all diagnoses.6

 

Multiple clinical guidelines recommend or strongly recommend the routine measuring and monitoring of clozapine levels.7, 8, 9

1. Siskind, et al. 2020. J Psychiatry Neuroscience; 45(4):200061.
2. Kelly, et al. 2018. Psychiatric Services; 69:224-227
3. Predmore, et al. 2015. Psychiatric Services; 66:343-345.
4. Cloutier, et al. 2016. Clin Psychiatry; 77(6):764-71.
5. Heslin, et al. 2012. HCUP Statistical Briefs #189.
6. Fingar, et al. 2014. HCUP Statistical Briefs #230.
7. The American Psychiatric Association Practice Guidelines for the Treatment of Patients with Schizophrenia; The Maudsley Prescribing Guidelines in Psychiatry; AGNP Consensus Guidelines for Therapeutic Drug Monitoring in Psychiatry
8. AGNP Consensus Guidelines for Therapeutic Drug Monitoring in Psychiatry.
9. The Maudsley Prescribing Guidelines in Psychiatry.

Clozapine

Antipsychotic Product Performance

Assay Range ng / mL Within-Laboratory Precision, %CV Method Comparison to LC-MS/MS
Low Control Medium Control High Control Slope Intercept Correlation Coefficient
68 – 1500 5.4 4.4 4.5 1.037 -27.8 0.9269

Expected Values

As for any laboratory test, the clinical context should be taken into consideration when interpreting clozapine result. 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 therapeutic reference range of 350 – 600 ng/mL in which therapeutic drug monitoring is strongly recommended.1


Request Information

If you are interested in ordering a test kit, please contact our USA headquarters via the contact information below, or fill out the contact form.

 

USA Headquarters

116 Research Drive,
Bethlehem, PA 18015
+1 (610) 419-6731