Infliximab drug level

Immunology

Tumor Necrosis Factor alpha (TNFɑ) belongs to the proinflammatory cytokines which promote and sustain inflammatory reactions. It is produced by macrophages and T cells and plays a central role in both acute and chronic inflammations. Consequently, chronic inflammatory diseases like Crohn’s disease, ulcerative colitis, rheumatoid arthritis, or psoriasis are increasingly being treated with antibodies against TNFɑ, which target directly the underlying inflammatory process.

During recent years, reports of an association between anti-drug antibodies (ADAs) and adverse effects of treatments both in CD and UC have surfaced. Development of ADAs is usually considered to be associated to immunogenicity of monoclonal antibodies. The clinical efficacy of an anti-TNFɑ therapy usually correlates with the trough level of the therapeutic antibody, or the drug level just before the next application of the anti-TNFɑ antibody. Several factors influence the trough level, among them dosage and frequency of anti-TNFɑ blocker infusion, disease activity, individual pharmacokinetics and immune reaction (formation of anti-drug antibodies, ADA)

The IDKmonitor® infliximab drug level ELISA for the determination of the drug level of infliximab (eg REMICADE®) measures quantitatively free infliximab in EDTA plasma and serum. In combination with the detection of ADA against infliximab, the IDKmonitor®infliximab drug level ELISA is an opportunity for the treating physician to monitor and optimize treatment early on.

Preparation of Patient: No special preparation.

Sample Type:

Serum (Gold and red cap); Plasma (lavender cap)

Temperature: + 4ºC or spun, separated and frozen at -20°C

Turnaround Time:

10 working days

Sample Stability:

Whole blood: unknown.

Separated: RT 7 days. Longer @ -20ºC

Instrument / Procedure:

ELISA

Units:
Reference Range:

(ug/mL) A detectable anti-TNF trough level (immediately pre-dose) is associated with a higher rate of clinical and endoscopic remission

Precautions:
Download full Primary Sample Management Document
Source:

IDK Infliximab drug level IFU

Accreditation Status:
Accredited
Non-Accredited

SAMPLE REQUIREMENTS FOR COAGULATION TESTS

PROCEDURE

Sample Requirements and Collection

  • Patients should be relaxed pre-venepuncture. Excessive stress and exercise will increase FVIII, vWF antigen and fibrinolysis. Venous occlusion should be avoided.  
  • Difficult venepuncture with trauma may lead to platelet activation with release of PF4 from alpha granules.
  • Venous blood should be collected into coagulation tubes containing Sodium Citrate 3.2%, 0.105M.
  • Specimens must be mixed immediately post venepuncture to avoid clot activation, by GENTLY inverting the tubes 5 to 10 times.
  • The ratio of whole blood to anticoagulant is crucial to clotting times. A target blood to anticoagulant ratio of 9:1 is optimal.  Under- or over- filled specimens will not be processed this can adversely affect results.  
  • Any warfarin treatment should be mentioned on the request form.
  • Sample rejection Criteria: Clotted sample, grossly hemolyzed sample, underfilled/overfilled specimen, unlabeled sample, mismatched patient ID, aged samples, wrong sample tube (citrate tube only).

Transportation and Storage

  • PT/INR specimens should be transported to the laboratory at room temperature.
  • Coagulation specimens should ideally be analysed within 4 hours of collection. Where this is not possible, centrifuge specimens at room temperature (RT) @ 1500RCF for at least 15 minutes, and then carefully remove the plasma from the cells, transfer to a fresh plastic plain tube and freeze at -20oC.  
  • Non-frozen coagulation specimens should be transported at RT ASAP to avoid deterioration of labile factors V and VIII.
  • Collection of blood through intravenous lines that have been previously flushed with heparin should be avoided. In the event blood is drawn from an indwelling catheter, the line should be flushed with 5ml of saline, and the first 5ml of blood or 6 times the line volume be drawn off and discarded before coagulation tube is filled.
  • Effect of freezing on Coagulation Specimens.
  • A 14days in-house study on the effect of freezing, on coagulation specimens at -20oC, showed that there was negligible and clinically non-significant effect of freezing on coagulation specimen results. Therefore frozen citrated coagulation samples are stable for 14 days at -20oC, post centrifugation. This study is available in-house for reference.
ESR Ref Ranges
Units of Measurement
MALE
FEMALE
>50 Years
mm/hr
0 - ≤12
0 - ≤15
<50 Years
mm/hr
0 - ≤8
0 - ≤10
Download Brochure
Download Sample Report
Analyte
Units of Measurement
MALE
FEMALE
WBC
10^9/L
4.0–10.0
4.0 - 10.0
RBC
10^12/L
5.0 ± 0.5
4.3 ± 0.5
HB
g/dL
15.0 ± 2.0
13.5 ± 1.5
HCT
L/L
0.45 ± 0.05
0.41 ± 0.05
MCV
fL
92 ± 9
92 ± 9
MCH
pg
29.5 ± 2.5
29.5 ± 2.5
MCHC
g/dL
33.0 ± 1.5
33.0 ± 1.5
PLT
10^9/L
280 ± 130
280 ± 130
MPV
fL
N/A
N/A
RDW
%
11.6 - 14.0
11.6 - 14.0
#Neut
10^9/L
2.0 – 7.0
(40 - 80%)
#Lymph
10^9/L
1.0 – 3.0
(20 - 40%)
#Mono
10^9/L
0.2 – 1.0
(2 - 10%)
#Eos
10^9/L
0.02 – 0.5
(1 - 6%)
#Baso
10^9/L
0.02 – 0.1
(<1 - 2%)
Analyte
Units of Measurement
MALE & FEMALE
WBC
10^9/L
Birth: 18 ± 8
Day 3: 15 ± 8
Day 7: 14 ± 8
Day 14: 14 ± 8
1 Month: 12 ± 7
2 Months: 10 ± 5
3–6 Months: 12 ± 6
1 Year: 11 ± 5
2–6 Years: 10 ± 5
6–12 Years: 9 ± 4
RBC
10^12/L
Birth: 6.0 ± 1.0
Day 3: 5.3 ± 1.3
Day 7: 5.1 ± 1.2
Day 14: 4.9 ± 1.3
1 Month: 4.2 ± 1.2
2 Months: 3.7 ± 0.6
3–6 Months: 4.7 ± 0.6
1 Year: 4.5 ± 0.6
2–6 Years: 4.6 ± 0.6
6–12 Years: 4.6 ± 0.6
HB
g/dL
Birth: 18.0 ± 4.0
Day 3: 18.0 ± 3.0
Day 7: 17.5 ± 4.0
Day 14: 16.5 ± 4.0
1 Month: 14.0 ± 2.5
2 Months: 11.2± 1.8
3–6 Months: 12.6 ± 1.5
1 Year: 12.6 ± 1.5
2–6 Years: 12.5 ± 1.5
6–12 Years: 13.5 ± 2.0
HCT
L/L
Birth: 0.60 ± 0.15
Day 3: 0.56 ± 0.11
Day 7: 0.54 ± 0.12
Day 14: 0.51 ± 0.12
1 Month: 0.43 ± 0.10
2 Months: 0.35 ± 0.07
3–6 Months: 0.35 ± 0.08
1 Year: 0.34 ± 0.04
2–6 Years: 0.37 ± 0.03
6–12 Years: 0.40 ± 0.05
MCV
fL
Birth: 110 ± 10
Day 3: 105 ± 13
Day 7: 107 ± 19
Day 14: 105 ± 19
1 Month: 104 ± 12
2 Months: 95 ± 8
3–6 Months: 76 ± 8
1 Year: 78 ± 6
2–6 Years: 81 ± 6
6–12 Years: 86 ± 9
MCH
pg
Birth: 34 ± 3
Day 3: 34 ± 3
Day 7: 34 ± 3
Day 14: 34 ± 3
1 Month: 33 ± 3
2 Months: 30 ± 3
3–6 Months: 27 ± 3
1 Year: 27 ± 2
2–6 Years: 27 ± 3
6–12 Years: 29 ± 4
MCHC
g/dL
Birth: 33.0 ± 3.0
Day 3: 33.0 ± 4.0
Day 7: 33.0 ± 5.0
Day 14: 33.0 ± 5.0
1 Month: 33.0 ± 4.0
2 Months: 32.0 ± 3.5
3–6 Months: 33.0 ± 3.0
1 Year: 34.0 ± 2.0
2–6 Years: 34.0 ± 3.0
6–12 Years: 34.0 ± 3.0
PLT
10^9/L
Birth: 100 – 450
Day 3: 210 – 500
Day 7: 160 – 500
Day 14: 170 – 500
1 Month: 200 – 500
2 Months: 210 – 650
3–6 Months: 200 – 550
1 Year: 200 – 550
2–6 Years: 200 – 490
6–12 Years: 170 – 450
Reticulocytes
10^9/L
Birth: 120 – 400
Day 3: 50 – 350
Day 7: 50 – 100
Day 14: 50 - 100
1 Month: 20 – 60
2 Months: 30 – 50
3–6 Months: 40 – 100
1 Year: 30 – 100
2–6 Years: 30 – 100
6–12 Years: 30 – 100
#Neut
10^9/L
Birth: 4 – 14
Day 3: 3 – 5
Day 7: 3 – 6
Day 14: 3 – 7
1 Month: 3 – 9
2 Months: 1.0 – 5
3–6 Months: 1 – 6
1 Year: 1 – 7
2–6 Years: 1.5 – 8
6–12 Years: 2 – 8
#Lymph
10^9/L
Birth: 3 – 8
Day 3: 2 – 8
Day 7: 3 – 9
Day 14: 3 – 9
1 Month: 3 – 16
2 Months: 4 – 10
3–6 Months: 4 – 12
1 Year: 3.5 – 11
2–6 Years: 6 - 9
6–12 Years: 1 - 5
#Mono
10^9/L
Birth: 0.5 – 2.0
Day 3: 0.5 – 1.0
Day 7: 0.1 – 1.7
Day 14: 0.1 – 1.7
1 Month: 0.3 – 1.0
2 Months: 0.4 – 1.2
3–6 Months: 0.2 – 1.2
1 Year: 0.2 – 1.0
2–6 Years: 0.2 – 1.0
6–12 Years: 0.2 – 1.0
#Eos
10^9/L
Birth: 0.1 – 1.0
Day 3: 0.1 – 2.0
Day 7: 0.1 – 0.8
Day 14: 0.1 – 0.9
1 Month: 0.2 – 1.0
2 Months: 0.1 – 1.0
3–6 Months: 0.1 – 1.0
1 Year: 0.1 – 1.0
2–6 Years: 0.1 – 1.0
6–12 Years: 0.1 – 1.0
Reference Ranges:
Age
Absolute Reference Range
Age
% Reference Range
0 - 1 day
324 - 617 x109/L
0 - 1 day
1.72 - 8.62%
1 - 5 days
85 - 400 x109/L
1 - 5 days
1.9 - 9.1%
5 days - 1 mth
34.2 - 724 x109/L
5 days - 1 mth
0.1 - 6.9%
1 - 3 mths
21.3 - 205 x109/L
1 - 3 mths
0.1 - 6.27%
3 - 12 mths
8.0 - 171 x109/L
3 - 12 mths
0.1 - 4.7%
1 - 3 yrs
55.6 - 120 x109/L
1 - 3 yrs
0.35 - 2.95%
3 - 7yrs
16.4 - 120.7 x109/L
3 - 7yrs
0.25 - 2.57%
Adult
35.2 - 122.8 x109/L
Adult
0.75 - 2.7%
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