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Test Code HCQWB Hydroxychloroquine, Blood


Specimen Required


Container/Tube: Lavender top (EDTA)

Specimen Volume: 1 mL

Collection Instructions:

1. Collect specimen immediately before next scheduled dose.

2. Send whole blood specimen in original tube. Do not aliquot.


Secondary ID

623295

Useful For

Monitoring whole blood hydroxychloroquine concentrations, assessing compliance, and adjusting dosage in patients

Method Name

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

Reporting Name

Hydroxychloroquine, B

Specimen Type

Whole Blood EDTA

Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time
Whole Blood EDTA Refrigerated (preferred) 28 days
  Ambient  28 days
  Frozen  28 days

Reject Due To

Gross hemolysis OK
Gross lipemia OK
Gross icterus OK
Clotted specimens Reject

Clinical Information

Hydroxychloroquine is used to treat symptoms of acute or chronic rheumatoid arthritis and lupus erythematosus. Adult doses range from 400 mg/week for suppressive therapy to 1200 mg/day for acute malaria attacks. Typical daily doses of 200 to 600 mg are used for lupus and rheumatoid diseases. Hydroxychloroquine has a long terminal elimination half-life in blood (>40 days), which exceed those in plasma. The oral bioavailability averages 79%.

 

Hydroxychloroquine accumulates in several organs, especially melanin-containing retina and skin. Mild to moderate overdose can result in gastrointestinal effects (ie, nausea, vomiting, and abdominal pain), headache, visual/hearing disturbances, and neuromuscular excitability. Acute hepatitis, cardiotoxicity, and retinopathy may occur with therapeutic doses. The effects of over dosage with hydroxychloroquine include headache, drowsiness, visual disturbances, convulsions, cardiovascular collapse and respiratory arrest. Toxic retinopathy has also been associated with higher doses and longer duration of use.

Reference Values

≥200 ng/mL

Interpretation

For systemic lupus erythematosus, therapeutic target whole blood concentrations of hydroxychloroquine of 1000-2000 ng/mL have been proposed.(1-3)

 

An effective therapeutic reference range of whole blood hydroxychloroquine concentrations of 750 to 1200 ng/mL was associated with 71% lower odds of active lupus and maintaining levels within this range reduced odds of flares by 26%.(4)

 

Whole blood hydroxychloroquine concentrations below 200 ng/mL denote noncompliance and risk of flare in lupus.(1) Concentrations of 500 ng/mL or higher are consistent with adherence.(2) Whole blood hydroxychloroquine monitoring is more stable, precise, and better correlated to efficacy than serum/plasma concentrations.(5)

Cautions

Specimens that are obtained from serum gel tubes are not acceptable, as the drug can absorb on the gel and lead to falsely decreased concentrations.

Clinical Reference

1. Costedoat-Chalumeau N, Houssiau F, Izmirly P, et al. A prospective international study on adherence to treatment in 305 patients with flaring sle: assessment by drug levels and self-administered questionnaires. Clin Pharmacol Ther. 2019;106(2):374-382. doi:10.1002/cpt.1194

2. 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

3. Costedoat-Chalumeau N, LE Guern V, Piette JC. Routine hydroxychloroquine blood concentration measurement in systemic lupus erythematosus reaches adulthood. J Rheumatol. 2015;42(11):1997-1999. doi:10.3899/jrheum.151094

4. Garg S, Chewning B, Hutson P, Astor BC, Bartels CM. Reference range of hydroxychloroquine blood levels that can reduce odds of active lupus and prevent flares. Arthritis Care Res (Hoboken). 2024;76(2):241-250. doi:10.1002/acr.25228

5. Petri M, Elkhalifa M, Li J, Magder LS, Goldman DW. Hydroxychloroquine blood levels predict hydroxychloroquine retinopathy. Arthritis Rheumatol. 2020;72(3):448-453

6. 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

7. Wang LZ, Ong RY, 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

8. Blanchet B, Jallouli M, Allard M, et al. SATO188 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.

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

Method Description

Reagent is added to the whole blood sample following the addition of deuterium-labeled internal standard. The mixture is centrifuged, and a portion of the supernatant is diluted with mobile phase for analysis and detection by liquid chromatography tandem mass spectroscopy.(Unpublished Mayo method)

Day(s) Performed

Tuesday, Thursday

Report Available

3 to 7 days

Specimen Retention Time

14 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
HCQWB Hydroxychloroquine, B 95921-3

 

Result ID Test Result Name Result LOINC Value
623295 Hydroxychloroquine, B 95921-3