Effective May 2, 2022.
Discontinued by Vendor (ARUP)
CDC does not recommend serology: https://www.cdc.gov/legionella/clinicians/diagnostic-testing.html
Legionella culture (LEGCUL)
Legionella Urinary Ag (LEGUAG)
Legionella pneumophila PCR (LEGPCR)
Effective April 14, 2022.
Specimens submitted for A1APHE testing will be stored frozen while reagents are unavailable; stability is three months.
ARUP Laboratories anticipates testing to resume in late May and will complete the backlog of specimens as soon as possible.
All changes effective May 16, 2022.
6 months – 29 years:
238-1019 pg/mL
30-39 years:
225-936 pg/mL
40-49 years:
182-801 pg/mL
50-59 years:
161-737 pg/mL
60-69 years:
132-752 pg/mL
70 years or greater:
118-776 pg/mL
Premenopausal:
136-689 pg/mL
Postmenopausal:
177-1015 pg/mL
9 components have been removed
5-fluoro-PINACA 3-methylbutanoic acid
4-fluoro-BINACA 3,3-dimethylbutanoic acid
5-fluoro-PICA 3,3-dimethylbutanoic acid
5-fluoro-PINACA3,3-dimethylbutanoic acid
MDMB-4en-PINACA butanoic acid
FUBINACA 3-methylbutanoic acid
FUBINACA 3,3-dimethylbutanoic acid
4-carboxy-NA-PIM
Reason for Discontinuation:
Vendor test discontinuation
Alternative Test:
Drug Detection Panel, Meconium, Qualitative (MECDRG) – Available 05/16/22
Effective February 26, 2022.
Updates:
Previously:
Change Overview
The majority of Cleveland Clinic Laboratories’ hematology analyzers are FDA-approved to report “immature granulocytes” (IG), which represent “left-shifted” myeloid precursors that are more mature than blasts (e.g. myelocytes). A small number of IG can be seen in a variety of benign conditions.
The reference range for IG is age-dependent, as listed below; however, normal individuals may occasionally have IG higher than the reference range. Because the hematology analyzers are highly accurate and precise, a staff (pathologist) review is unlikely to add additional information in the setting of a small population of IG.
IG have not been specified in previous reports because of concern for over-interpretation of small numbers of IG. However, reporting IG is in accordance with the analyzer manufacturer’s recommendations, will improve laboratory efficiency, and is becoming the norm among laboratories using these instruments, including in major medical centers.
IG are NOT blasts. Any sample with blasts will have a manual differential performed and a separate blast % will be reported.
Immature Granulocyte Reference Ranges, by patient age (cells/µL):
≤ 2 days:
< 0.29
2 < 14 days:
< 0.28
14 – 30 days:
< 0.23
31 – 90 days:
< 0.10
91 – 180 days:
< 0.07
0.5 – < 2 years:
< 0.15
2 – < 6 years:
< 0.07
6 – < 12 years:
< 0.05
12 – < 18 years:
< 0.04
>/= 18 years:
< 0.01
Reactive lymphocytes have been added to the absolute lymphocyte count (ALC) because they are physiologically active and should be included in this measurement of a patient’s immune function.
Name
Updated Reporting
Previous Reporting
CBCDIF with <2.0% Immature Granulocytes (IG)
IG% reported in chart
IG% added to neutrophil%
CBCDIF with >1.9% IG
Manual differential performed
Manual differential performed
CBCDIF with Suspected Blasts
Manual differential performed, blast % reported
Manual differential performed, blast % reported
Absolute Lymphocyte Count (ALC)
ALC = WBC x (lymphocyte % + reactive lymphocyte %)
ALC = WBC x lymphocyte %
Effective February 28, 2022.
The upright reference interval for adults has been updated to < 35.4 ng/dL (from 3.1 – 35.4 ng/dL).
The following interpretative comment will be appended to the results:
The reference interval for plasma/serum aldosterone is based on a normal sodium intake and upright position. High sodium intake may suppress aldosterone, and low sodium intake may increase aldosterone. The supine reference interval is <23.7 ng/dL.
A ratio of aldosterone in ng/mL to direct renin in pg/mL greater than or equal to 3.8 is a positive screening test result for primary aldosteronism when aldosterone is greater than or equal to 15 ng/dL.
Effective February 28, 2022.
The supine reference intervals will display next to the results as:
< 41 years:
4.2 – 52.2 pg/mL
41 – 99 years:
3.6 – 81.6 pg/mL
The following interpretative comment will be appended to the results:
The reference interval for direct renin is based on an upright position. The supine reference intervals are:
< 41 years:
3.2 – 33.2 pg/mL
> 41 years:
2.5 – 45.1 pg/mL
A ratio of aldosterone in ng/mL to direct renin in pg/mL greater than or equal to 3.8 is a positive screening test result for primary aldosteronism when aldosterone is greater than or equal to 15 ng/dL.
Effective February 28, 2022.
The reference interval will be updated to <3.8 (from < 4.0).
The following interpretative comment will be appended to the results:
A ratio of aldosterone in ng/mL to direct renin in pg/mL greater than or equal to 3.8 is a positive screening test result for primary aldosteronism when aldosterone is greater than or equal to 15 ng/dL.
April 7, 2022: Digoxin, Free, Serum (DIGFR) testing has resumed, and DIGFR ordering has been re-enabled.
For more information, please contact Client Services for assistance.
Effective February 28, 2022.
Any new DIGFR orders placed after February 28, 2022 will be canceled.
Cleveland Clinic Laboratories will provide an update when Digoxin, Free, Serum testing is available again.
Specimen Type:
Endocervical
Collection Container:
APTIMA Unisex Collection Kit
Transport Temperature:
Refrigerated
Specimen Type:
Urethral
Collection Container:
APTIMA Unisex Collection Kit
Transport Temperature:
Refrigerated
Specimen Type:
Vaginal/Genital
Collection Container:
Aptima Multitest Swab (STM)
Transport Temperature:
Refrigerated
Specimen Type:
Urine, random
Volume:
2 mL
Collection Container:
APTIMA Urine Tube
Transport Temperature:
Refrigerated
Normal Range:
Negative
Clients anticipated to be affected by this change have already been notified by a CCL representative.
If you or your organization has not been contacted, no action is required at this time.
Following the February 26 go-live:
If you experience issues placing orders or receiving test results, please contact your CCL Account Manager immediately or call Client Services at 800.628.6816 for assistance.
Following the implementation of Beaker, Cleveland Clinic Laboratories will begin sending daily client reports via Secure Messaging. This new system enables safe, protected transferring of sensitive information.
Recipients can only read a Secure Message by logging into the Secure Messaging portal. Reports will be available within the Secure Messaging portal for ten days. Requests for information older than ten days can be placed through Technical Sales Support.
All changes effective February 22, 2022.
Specimen Type:
Plasma
Volume:
1 mL
Minimum Volume:
0.5 mL
Collection Container:
Light Green Lithium Heparin PST
Note: Plasma specimens in Sodium Heparin tubes are no longer acceptable.
Transport Temperature:
Refrigerated
Additional Information:
Remove plasma ASAP or within 2 hours of collection.
Specimen Type:
Plasma
Volume:
1 mL
Minimum Volume:
0.4 mL
Collection Container:
Light Green Lithium Heparin PST
Note: Plasma specimens in Sodium Heparin tubes are no longer acceptable.
Transport Temperature:
Refrigerated
Additional Information:
Separate plasma from cells within 2 hours of collection and transfer to a standard aliquot tube.
Specimen Type:
Plasma
Volume:
1 mL
Minimum Volume:
0.5 mL
Collection Container:
Lavender K2EDTA
Transport Temperature:
Refrigerated
Additional Information:
Morning fasting specimen preferred.
Patient Prep:
For patients receiving therapy with high biotin doses (e.g. greater than 5 mg/day), the specimen should not be drawn until at least 8 hours after the last biotin administration.
Centrifuge and separate plasma from cells ASAP or within 2 hours of collection. Transfer plasma to a standard aliquot tube.
Specimen Type:
Plasma
Volume:
3 mL
Minimum Volume:
2.5 mL
Collection Container:
Lavender K2EDTA
Transport Temperature:
Frozen
Additional Information:
Separate plasma from cells within 24 hours and transfer plasma to a standard aliquot tube. Please submit the most recent viral load and test date, if available.
Specimen Type:
Plasma
Volume:
1 mL
Minimum Volume:
0.5 mL
Collection Container:
Light Green Lithium Heparin PST
Note: Plasma specimens in Sodium Heparin tubes are no longer acceptable.
Transport Temperature:
Refrigerated
Additional Information:
Separate plasma from cells ASAP or within 2 hours of collection and transfer to a standard aliquot tube.
13-99 Years:
28 – 100 U/L
18-99 Years:
13 – 53 U/L
18-49 Years:
25 – 122 nmol/L
50-99 Years:
17 – 125 nmol/L
18-49 Years:
17 – 56 nmol/L
50-99 Years:
19 – 76 nmol/L
18 Years and Older:
26 – 192 U/L
18 Years and Older:
39 – 308 U/L
Female, Premenopausal:
25 – 573 pg/mL
Less than 9 U:
Negative – No significant level of Schistosoma IgG antibody detected.
9 – 11 U:
Equivocal – Recommend repeat testing in 2-4 weeks with a fresh sample.
Greater than 11 U:
Positive – IgG antibodies to Schistosoma detected, which may suggest current or past infection.
Add component CYP2C19 Phenotype
Reason for Discontinuation:
No longer offered by vendor
Alternative Test:
von Willebrand Disease (VWF) Sequencing (VWFSEQ) – Available 02/26/22
Reason for Discontinuation:
No longer offered by vendor
Effective December 14, 2021.
HIV-1 by Western Blot (HIV1CO) testing performed by CCL’s partnered reference laboratory is experiencing extended test delays caused by a nationwide shortage of testing kits.
These delays are anticipated to affect HIV1CO testing until February 2022.
Test name:
HIV-1/2 Ab Confirmatory
Order code:
HIV12M
Specimen type:
Serum
Collection container:
Gold Serum Separation Tube (SST)
Alternative specimen type:
Plasma
Alternative collection container:
Lavender K2EDTA Tube
Transport temperature:
Refrigerated
There may also be delays in fulfilling requests for these items, or an approved alternative swab may be provided instead.
If you have any questions, please contact your CCL Account Manager or Client Services.
