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COVID-19 Severe Disease Progression Risk Profile

CPT: 82728; 83520; 83615; 83880; 84145; 85025; 85379; 86140
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Test Includes

C-Reactive Protein (CRP), Quantitative; D-Dimer; Ferritin, Serum; Interleukin-6, Serum; Lactic Acid Dehydrogenase (LD); Neutrophil to Lymphocyte Ratio (NLR), Complete Blood Count (CBC) With Differential and Platelet; NT-proBNP; Procalcitonin


Special Instructions

This test may exhibit interference when sample is collected from a person who is consuming a supplement with a high dose of biotin (also termed as vitamin B7 or B8, vitamin H, or coenzyme R). It is recommended to ask all patients who may be indicated for this test about biotin supplementation. Patients should be cautioned to stop biotin consumption at least 72 hours prior to the collection of a sample.


Related Documents


Specimen Requirements


Specimen

Serum, plasma, and whole blood


Volume

5 mL serum, 2 mL plasma (sodium citrate), and 4 mL whole blood (EDTA)


Minimum Volume

3.5 mL serum, 1 mL plasma (sodium citrate), and 4 mL whole blood (Note: This volume does not allow for repeat testing.)


Container

Gel-barrier tube, blue-top (sodium citrate) tube, and lavender-top (EDTA) tube


Collection

Blood should be collected in a blue-top tube containing 3.2% buffered sodium citrate. Evacuated collection tubes must be filled to completion to ensure a proper blood to anticoagulant ratio. The sample should be mixed immediately by gentle inversion at least six times to ensure adequate mixing of the anticoagulant with the blood. A discard tube is not required prior to collection of coagulation samples. When noncitrate tubes are collected for other tests, collect sterile and nonadditive (red-top) tubes prior to citrate (blue-top) tubes. Any tube containing an alternate anticoagulant should be collected after the blue-top tube. Gel-barrier tubes and serum tubes with clot initiators should also be collected after the citrate tubes. Centrifuge and carefully remove the plasma using a plastic transfer pipette, being careful not to disturb the cells.Transfer the plasma into a Labcorp PP transpak frozen purple tube with screw cap (Labcorp No 49482). Freeze plasma within four hours of blood collection and maintain frozen until tested. To avoid delays in turnaround time when requesting multiple tests on frozen samples, please submit seperate frozen specimens for each test requested.


Storage Instructions

Frozen: Serum and plasma

Room temperature: Serum and whole blood (EDTA)


Test Details


Use

Comprehensive panel for the assessment of patients at risk of severe COVID-19 disease progression


Limitations

For Interleukin-6, Serum [140916]: This test has not been FDA cleared or approved. This test has been authorized by FDA under and EUA for use by authorized laboratories. This test has been authorized only to assist in identifying severe inflammatory response, when used as an aid in determining the risk of intubation with mechanical ventilation in confirmed COVID-19 patients. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of medical devices under Section 564(b)(1) of the Act, 21 U.S.C. & 360bbb-3(b), unless the authorization is terminated or revoked sooner.

Further limitations include:

• For diagnostic purposes, the results should always be assessed in conjunction with the patient's medical history, clinical examination and other findings.

• Individual IL-6 levels need to be considered in combination with other clinical findings to mitigate the possible risks of false positive or false negative IL-6 results.

• In the event of a false positive result, risk to patients could include additional unnecessary intensive care admission, intubation with mechanical ventilation, and other unnecessary supportive therapy.

• Low IL-6 levels indicate that it is less likely that the patient suffers from a cytokine release syndrome and the risk for respiratory support is reduced. However, low levels if IL-6 do not preclude disease progression and future development of severe inflammatory response.

• A false negative result may occur if the test reports lower values than actual levels of IL-6 that are in the sample. When diagnostic testing is negative, the possibility of a false negative result should be considered in the context of a patient's clinical presentation and the presence of clinical signs and symptoms consistent with severe inflammatory response.

• Risk to a patient of a false negative result include: delayed or lack of supportive respiratory treatment, or other unintended adverse events.

• In rare cases, interference due to extremely high titers of antibodies to analyte-specific antibodies, streptavidinor ruthenium can occur. These effects are minimized by suitable test design.


Methodology

See individual test components.


References

Aloisio E, Chibireva M, Serafini L, et al. A Comprehensive Appraisal of Laboratory Biochemistry Tests as Major Predictors of COVID-19 Severity. Arch Pathol Lab Med. 2020 Dec 1;144(12):1457-1464.32649222
Cicculo A, Borghetti A, Dal Verme LZ, et al. Neutrophil-to-lymphocyte ratio and clinical outcome in COVID-19: a report from the Italian front line. Int J Antimicrob Agents. 2020 Aug;56(2):106017.32437920
Gao Y, Li T, Han M, et al. Diagnostic utility of clinical laboratory data determinations for patients with the severe COVID-19. J Med Virol. 2020 Jul;92(7):791-796.32181911
Kerboua KE. NLR: A Cost-effective Nomogram to Guide Therapeutic Interventions in COVID-19. Immunol Invest. 2021 Jan;50(1):92-100.32482134
Tatum D, Taghavi S, Houghton A, Stover J, Toraih E, Duchesne J. Neutrophil-to-lymphocyte ratio and outcomes in Louisiana COVID-19 patients. Shock. 2020 Nov;54(5):652-658.32554992
Tjendra Y, Al Mana AF, Espejo AP, et al. Predicting Disease Severity and Outcome in COVID-19 Patients. Arch Pathol Lab Med. 2020 Dec 1;144(12):1465-1474.32818235
Velavan TP, Meyer CG. Mild versus severe COVID-19: Laboratory markers. Int J Infect Dis. 2020 Jun;95:304-307.32344011
Yang AP, Liu JP, Tao WQ, Li HM. The diagnostic and predictive role of NLR, d-NLR and PLR in COVID-19 patients. Int Immunopharmacol. 2020 Jul;84:106504.32304994

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
164049 COVID-19 Severe Disease Risk 001115 LDH IU/L 2532-0
164049 COVID-19 Severe Disease Risk 004598 Ferritin, Serum ng/mL 2276-4
164049 COVID-19 Severe Disease Risk 140922 Interleukin-6, Serum pg/mL 26881-3
164049 COVID-19 Severe Disease Risk 143001 NT-proBNP pg/mL 33762-6
164049 COVID-19 Severe Disease Risk 164752 Procalcitonin ng/mL 33959-8
164049 COVID-19 Severe Disease Risk 006627 C-Reactive Protein, Quant mg/L 1988-5
164049 COVID-19 Severe Disease Risk 115206 D-Dimer mg/L FEU 48065-7
164049 COVID-19 Severe Disease Risk 005025 WBC x10E3/uL 6690-2
164049 COVID-19 Severe Disease Risk 005033 RBC x10E6/uL 789-8
164049 COVID-19 Severe Disease Risk 005041 Hemoglobin g/dL 718-7
164049 COVID-19 Severe Disease Risk 005058 Hematocrit % 4544-3
164049 COVID-19 Severe Disease Risk 015065 MCV fL 787-2
164049 COVID-19 Severe Disease Risk 015073 MCH pg 785-6
164049 COVID-19 Severe Disease Risk 015081 MCHC g/dL 786-4
164049 COVID-19 Severe Disease Risk 105007 RDW % 788-0
164049 COVID-19 Severe Disease Risk 015172 Platelets x10E3/uL 777-3
164049 COVID-19 Severe Disease Risk 015107 Neutrophils % 770-8
164049 COVID-19 Severe Disease Risk 015123 Lymphs % 736-9
164049 COVID-19 Severe Disease Risk 015131 Monocytes % 5905-5
164049 COVID-19 Severe Disease Risk 015149 Eos % 713-8
164049 COVID-19 Severe Disease Risk 015156 Basos % 706-2
164049 COVID-19 Severe Disease Risk 115398 Immature Cells n/a
164049 COVID-19 Severe Disease Risk 015909 Neutrophils (Absolute) x10E3/uL 751-8
164049 COVID-19 Severe Disease Risk 015917 Lymphs (Absolute) x10E3/uL 731-0
164049 COVID-19 Severe Disease Risk 015912 Neut/Lymph Ratio ratio n/a
164049 COVID-19 Severe Disease Risk 015925 Monocytes(Absolute) x10E3/uL 742-7
164049 COVID-19 Severe Disease Risk 015933 Eos (Absolute) x10E3/uL 711-2
164049 COVID-19 Severe Disease Risk 015941 Baso (Absolute) x10E3/uL 704-7
164049 COVID-19 Severe Disease Risk 015108 Immature Granulocytes % 71695-1
164049 COVID-19 Severe Disease Risk 015911 Immature Grans (Abs) x10E3/uL 53115-2
164049 COVID-19 Severe Disease Risk 015945 NRBC % 58413-6
164049 COVID-19 Severe Disease Risk 015180 Hematology Comments: 18314-5
164049 COVID-19 Severe Disease Risk 164046 Severe Disease Progression n/a
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115400 Bands % 35332-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115401 Metamyelocytes % 28541-1
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115403 Myelocytes % 26498-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115404 Promyelocytes % 26498-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115405 Blasts/blast like cells % 26498-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115406 Megakaryocytes % 19252-6
Reflex Table for Immature Cells
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 115399 Immature Cells 115265 Other, Lineage Uncertain % 55433-7

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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2021, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf