Test Catalog

Test Id : HCQWB

Hydroxychloroquine, Blood

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Method Name
A short description of the method used to perform the test

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

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Hydroxychloroquine, B

Aliases
Lists additional common names for a test, as an aid in searching

Axemal

Dolquine

Plaquenil

Quensyl

Specimen Type
Describes the specimen type validated for testing

Whole Blood EDTA

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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.

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

0.5 mL

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

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

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

> or =200 ng/mL

Interpretation
Provides information to assist in interpretation of the test results

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
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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
Recommendations for in-depth reading of a clinical nature

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
Describes how the test is performed and provides a method-specific reference

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Tuesday, Thursday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

3 to 7 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

14 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Mayo Clinic Laboratories - Rochester Superior Drive
CLIA Number: 24D1040592

Fees :
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

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
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

80220

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
HCQWB Hydroxychloroquine, B 95921-3
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
623295 Hydroxychloroquine, B 95921-3

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2025-12-30