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Test Code HCQ Hydroxychloroquine, Serum

Useful For

Monitoring serum hydroxychloroquine concentrations, assessing compliance, and adjusting dosage in patients

Method Name

Liquid Chromatography Tandem Mass Spectrometry (LC-MS/MS)

Reporting Name

Hydroxychloroquine, S

Specimen Type

Serum Red


Specimen Required


Supplies: Sarstedt Aliquot Tube, 5 mL (T914)

Collection Container/Tube: Red top (gel tubes/SST are not acceptable)

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions:

1. Collect specimen immediately before next scheduled dose.

2. Within 2 hours of collection, centrifuge, and aliquot serum into a plastic vial.


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Red Refrigerated (preferred) 28 days
  Frozen  28 days
  Ambient  21 days

Reference Values

For suppressive treatment of malaria, suggested plasma or serum concentrations should be >10 ng/mL.

 

For systemic lupus erythematosus, proposed serum target concentrations should be ≥500 ng/mL.

Interpretation

The serum concentration should be interpreted in the context of the patient's clinical response and may provide useful information in patients showing poor response, noncompliance, or adverse effects. Concentrations less than 106 ng/mL have been associated with noncompliance.

Clinical Reference

1. McChesney EW BW, McAuliff JP: Laboratory studies on the 4-aminoquinoline antimalarials: II. Plasma levels of chloroquine and hydroxychloroquine in man after various oral dosage regimens. Antibiot Chemother (Northfield). 1962;12(9):583-594

2. Mok CC, Penn HJ, Chan KL, Tse SM, Langman LJ, Jannetto PJ. Hydroxychloroquine serum concentrations and flares of systemic lupus erythematosus: A longitudinal cohort analysis. Arthritis Care Res. 2016;68(9):1295-1302. doi:10.1002/acr.22837

3. Durcan L, Clarke WA, Magder LS, Petri M. Hydroxychloroquine blood levels in systemic lupus erythematosus: clarifying dosing controversies and improving adherence. J Rheumatol. 2015;42(11):2092-2097. doi:10.3899/jrheum.150379

4. Blanchet B, Jallouli M, Allard M, et al. Whole blood versus serum hydroxychloroquine levels for drug monitoring of patients with systemic lupus erythematosus: preliminary results of a pharmacological study. Ann Rheum Dis. 2019;78(2):1168-1169. Abstract SAT0188

5. Soichot M, Megarbane B, Houze P, et al. Development, validation and clinical application of a LC-MS/MS method for the simultaneous quantification of hydroxychloroquine and its active metabolites in human whole blood. J Pharm Biomed Anal. 2014;100:131-137. doi:10.1016/j.jpba.2014.07.009

6. Wang LZ, Ong RYL, Chin TM, et al. Method development and validation for rapid quantification of hydroxychloroquine in human blood using liquid chromatography-tandem mass spectrometry. J Pharm Biomed Anal. 2012;61:86-92. doi:10.1016/j.jpba.2011.11.034

7. Disposition of Toxic Drugs and Chemicals in Man. 10th ed. Biomedical Publications; 2014

8. Tett SE, Cutler DJ, Day RO, Brown KF. A dose-ranging study of the pharmacokinetics of hydroxy-chloroquine following intravenous administration to healthy volunteers. Brit J Clin Pharmacol. 1988;26(3):303-313

9. Gautret P, Lagier JC, Parola P, et al. Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020;56(1):105949. doi:10.1016/j.ijantimicag.2020.105949

10. Kim SH: Comparison of lopinavir/ritonavir or hydroxychloroquine in patients with mild coronavirus disease (COVID-19). US National Library of Medicine (NLM). 2020. Accessed April 23, 2024. Available at clinicaltrials.gov/ct2/show/NCT04307693

11. Lu H: Efficacy and safety of hydroxychloroquine for treatment of pneumonia caused by 2019-nCoV (HC-nCoV). US National Library of Medicine (NLM). 2020. Accessed April 23, 2024. Available at clinicaltrials.gov/ct2/show/NCT04261517

12. Post-exposure prophylaxis for SARS-coronavirus-2. US National Library of Medicine (NLM). 2020. Accessed April 23, 2024. Available at clinicaltrials.gov/ct2/show/NCT04308668

Report Available

3 to 7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

Test Classification

This test was developed and its performance characteristics determined by Mayo Clinic in a manner consistent with CLIA requirements. It has not been cleared or approved by the US Food and Drug Administration.

CPT Code Information

80220

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HCQ Hydroxychloroquine, S 3684-8

 

Result ID Test Result Name Result LOINC Value
64947 Hydroxychloroquine, S 3684-8

Day(s) Performed

Monday, Wednesday, Friday

Forms

If not ordering electronically, complete, print, and send a Therapeutics Test Request (T831) with the specimen.