COMPLEMENT C4

Cat.No. Pack name Packing (Content)

BLT20008 C4 5 x 25 ml Buffer
1 x 10 ml Antiserum
1 x 1 ml Calibrator Sample collection Specificity : Monospecific
Use fresh serum. If the test can not be carried out on the same day, Interferences : No interference for : Haemoglobin (1000 mg/dl),
IVD the serum may be stored at 2 - 8°C for 48 hours. If stored for a longer Na-citrate (1000 mg/dl), Heparin (50 mg/dl), Turbidity (5%), Billirubin
period, the sample should be frozen. (20 mg/dl) and Triglyceride (2500 mg/dl).
Intended Use
Quantitative determination of Complement C4 (C4) in human Limitations : None
Automation
serum by turbidimetric immunoassay. Comparison with Nephelometry :
Application procedures on clinical chemistry analyzers are available
Diagnostic Implications upon request.
Complement C4 is a constituent of C3 convertase and C5 y= 0.9341x-0.1518
Manual Procedure
convertase. r = 0.9940
Sample/Control: dilute 1:10 in saline 9 g/l
Decreased levels are found in hereditary angioneurotic oedema,
Reference curve: generate a reference curve by diluting the standard
immune complex diseases and congenital deficiencies.
high level 1:10, 1:20, 1:40, 1:80, 1:160 in saline 9 g/l Use saline 9 g/l
Precautions and warnings
as zero point.
Method Test: Mix 100 µl diluted samples, standards and control(s) with 900 µl 1. In vitro diagnostic use only.
Measurement of antigen-antibody reaction by the end-point buffer. Read optical density (OD1) of samples, standards and 2. Sodium azide has been reported to form lead or copper azide in
method. control(s) at 340 nm. Add 70 µl of C4 Antiserum. Mix and incubate for laboratory plumbing which may explode on percussion. Flush
5 minutes at room temperature. Read optical density (OD2) of drains with water thoroughly after disposing of fluids containing
Reagents Provided samples, standards and control(s) at 340 nm. sodium azide.
3. Polyethylene glycol is non biohazardous.
Buffer Calculate ∆OD’s, plot a standard curve and read the concentration of 4. Each donor unit used in the preparation of the standards and
Phosphate buffered saline (pH 7.43) controls and samples. controls was found to be negative for the presence of HIV1 and
Polyethylene glycol (40 g/l) HIV2 antibodies, as well as for the hepatitis B surface antigen
Sodium azide (0.95 g/l) Reference Values and anti-hepatitis C antibodies, using a method approved by the
9 - 36 mg/dl (IFCC) FDA.
Antiserum This range is given for orientation only. Each Laboratory should
Phosphate buffered saline (pH 7.43) establish its own reference values.
Polyclonal goat anti-human C4C (variable)
Sodium azide (0.95 g/l) Performances
The performance characteristics for the Complement C4 reagents
were measured on a clinical chemistry analyzer.
Calibrator
Defibrinated human plasma, liquid stabilised. Contains 0.09 %
sodium azide. Measuring Range : 0 - 80 mg/dl
Concentration: See the bottle label Detection Limit : 2 mg/dl
Hook effect : > 1000 mg/dl
Preparation and Stability of Reagents Sensitivity : 0.0022 ABS units / concentration unit

Reagent Preparation
Precision: Low Medium High
Liquid reagents, ready to use.
[%CV] Intra-Run 4.54 2.18 3.97
Inter-Run 4.17 3.08
Stability and Storage
The reagents are stable until expiry date when kept at 2-8°C.
Stability in the instrument is at least 4 weeks if contamination is Accuracy : Control Assigned Measured
avoided. Do not freeze. [mg/dl] Biorad 1 16 (13-19) 16.7
Biorad 2 52 (42-62) 47.4
Reagents required but not supplied
0.9 g % sodium chloride QUALITY SYSTEM CERTIFIED
ISO 9001 ISO 13485

12000141 Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ

e-mail: diagnostics@erbalachema.com, www.erbamannheim.com
N/180/16/A/INT Date of Revision: 27.1.2016
References
1. Dati, F. et al., Lab. Med. 13, 87 (1989)
2. Müller-Eberhard, H.H., Ann. Rev. Biochem. 44, 697 (1975)
3. Lachmann, P.J., Hobart, M.J. and Ashton, W.P. (1973) in
Handbook of Experimental Immunology, 2nd Ed., 16, Ed.
D.M. Weir, Blackwell Scientific Publications

USED SYMBOLS:

REF Catalogue No CE Mark - Device comply

with the Directive 98/79/EC
LOT Batch Code IVD In Vitro Diagnostics

Expiry Date Consult Instruction for Use

Manufactured by Storage temperature

COMPLEMENT C4 Product Name CONT Content

12000141 Erba Lachema s.r.o., Karásek 1d, 621 00 Brno, CZ

e-mail: diagnostics@erbalachema.com, www.erbamannheim.com
N/180/16/A/INT Date of Revision: 27.1.2016