Soluble Complement 5b-9 (sC5b-9) - Machaon Diagnostics

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Soluble Complement 5b-9 (sC5b-9)

Justification

Elevations in soluble Complement 5b-9 (sC5b-9) have been associated with increased activation of the alternative complement pathway. Increased complement activation may be seen with aHUS and other TMAs, and may be a sensitive early predictor of the development of transplant associated TMA. In a cohort of 67 pediatric patients who had an allogeneic HSCT, an increase in sC5b-9 concentration from baseline had 100% sensitivity and 53% specificity for TA-TMA.

STAT: < 24 hours (7 days a week)

ELISA

Draw Tube: Purple Top

Sample Type: EDTA Plasma

Test Summary

Specimen Requirements

	Sample Type	Volume Required	Minimum Volume	Stability
PREFERRED	EDTA Plasma	1mL	0.5mL	Frozen (-20C): 72 hours Frozen (-80C): 6 months
ALTERNATIVE	-	-	-	-

REJECTION CRITERIA	Thawed in transit if shipped frozen, refrozen, clotted sample
SPECIAL INSTRUCTIONS	Process and freeze samples within two hours of collection. Transport under dry ice.

General Information

METHODOLOGY	ELISA
STAT TAT	< 24 hours (7 days a week)
STAT TAT Performance	> 90% of results released in 21.2 hours 7 days a week
ROUTINE TAT	< 48 hours (Monday-Friday)
ALTERNATIVE NAMES	soluble C5b-9, sC5b-9, soluble MAC, sMAC, membrane attack complex, TCC, terminal complement, complement activation
DESCRIPTION	Chromogenic ELISA for the quantitative detection of soluble complement 5b-9, also known as the soluble membrane attack complex (sMAC).
LIMITATIONS	-
NORMAL RANGE	< 250 ng/mL
ASSOCIATED TESTING	-
REFERENCES	Bomback AS et al. Clin J Am Soc Nephrol. 2012 May;7(5):748-56. Nicolas C et al. Pediatr Nephrol. 2014;29(1):85. Mezö B, Horváth O, et al. Validation of Early Increase in Complement Activation Marker sC5b-9 as a Predictive Biomarker for the Development of Thrombotic Microangiopathy After Stem Cell Transplantation. Front. Med. 2020 Oct 6; 7:569291. doi: 10.3389/fmed.2020.569291 Horváth O, Kállay K, et al. Early Increase in Complement Terminal Pathway Activation Marker sC5b-9 Is Predictive for the Development of Thrombotic Microangiopathy after Stem Cell Transplantation. Biol Blood Marrow Transplant 2018 May; 24(5):989-996.
SAMPLE REPORT	Upon request
NEW YORK STATE APPROVED	Yes

Test Codes

ORDER CODE	P3364
CPT CODE	86160
LOINC CODE	93244-2