Download pdf - Elecsys® Assay interferences - Dialog Roche · Elecsys® Assay interferences Page 1 Version 4.6 Sep. 2014 The assay is unaffected by Reagent type Assay cat.no. Bilirubin (µmol/l)#

Elecsys® Assay interferences

Page 1 Version 4.6 Sep. 2014

The assay is unaffected by Reagent type

Assay cat.no.

Bilirubin (µmol/l)#

Hemolysis (HB mmol/l)#

Lipemia (Intralipid or triglycerides mg/dl)# Ë

Biotin (nmol/l)#

Rheumatoid factors (U/ml)#

Dialysis

Others

Thyroid FT3 III 06437206

< 1128 < 0.621 < 2000 < 286 < 1200 IgG < 7 g/dl IgM < 1 g/dl

IgA < 1.6 g/dl FT4 II

06437281 < 701 < 0-621 < 2000 < 81.8 < 339 IgG < 7 g/dl

IgM < 1 g/dl IgA < 1.6 g/dl

T3 11731360

< 599 < 1.2 < 1800 < 40.9 > 40.9 ↑

< 1500 no interference

T4 12017709

< 633 < 1.4 < 2500 < 409 < 2400 no interference

TSH 11731459

< 701 < 0.621 > 0.621 ↓

< 1800 < 102 > 102 ↓


T-uptake 11731394

< 701 < 1.2 < 2000 < 164 > 164 ↓


Calcitonin 06445853

< 1128 < 0.124 < 2000 < 163 < 1200 IgG < 4 g/dl IgM < 0.7 g/dl IgA < 1.6 g/dl

Tg II 05118921

< 1128 < 0.373 < 2000 < 123 < 600 IgG ≤ 2 g/dl IgM ≤ 0.5 g/dl IgA ≤ 1.6 g/dl

Anti-Tg 06368697

< 1129 < 1.05 < 2000 < 246 < 300

Anti-TPO 06368590

< 1129 < 0.93 < 2000 < 40.9 < 1500

Anti-TSHR

04388780

< 427 < 0.248 < 1500 < 41 < 600



The assay is unaffected by

Reagent type

Assay cat.no.


Hemolysis (HB

mmol/l)#


Biotin (nmol/l)

#


Dialysis

Others

Cardiac CK-MB STAT 05957648

CK-MB 05894808

< 581 < 0.311 < 1500 < 123 < 1500 no interference

IgG < 7 g/dl IgM < 1 g/dl IgA < 6 g/dl

Albumin < 20 g/dl Digoxin

11820796 < 1112 < 0.621 < 1500 < 409 < 1630

Digitoxin 03002659

< 633 < 0.683 > 0.683 ↑

< 1500 < 205 < 1500

Myoglobin STAT 11820788 Myoglobin 12178214

< 1112 < 0.869 < 2200 < 205 < 1500

proBNP II STAT 05390109 proBNP II 04842464

< 428 < 0.621 < 1500 < 123 < 1500

Troponin I STAT 04660307 Troponin I 05094810

< 428 < 0.247 > 0.247 ↓

< 1500 < 123 < 1500

Troponin T hs STAT

05092728 Troponin T hs

05092744

< 428 < 0.062 > 0.062 ↓

< 1500 < 82 > 82 ↓

< 1500




Reagent type

Assay cat.no.


Hemolysis (HB

mmol/l)#


Biotin (nmol/l)

#


Dialysis

Others

Hormones ACTH 03255751

< 428

< 0.25 > 0.25 ↓

< 1500 < 246 < 400 > 400 ↑

AMH 06331076

< 1129 < 0.621 < 1000

< 143

< 1000 IgG ≤ 2.5 g/dl IgM ≤ 0.5 g/dl IgA ≤ 1.8 g/dl

Cortisol 11875116

< 1026 < 1.2 < 2700 < 123 < 1100

DHEA-S 03000087

< 222 > 222 ↑

< 0.35 > 0.35 ↑

< 2000 < 123 > 123 ↑

< 600 > 600 ↑

Estradiol II 03000079

< 1129 < 0.621 < 1000 > 1000 ↓

< 147 > 147 ↑

< 1200

FSH 11775863

< 1094 < 0.621 < 1900 < 246 > 246 ↓

< 2250

HCG STAT 03300811

< 496 > 496 ↓

< 0.932 < 2400 < 164 < 667 > 667 ↑

no interference

no interference

HCG+b 03271749

< 410

< 0.621 < 1400 < 327 < 3400

no interference

no interference

LH 11732234

< 1129 < 0.621 < 1900 < 205 > 205 ↓

< 1500

Progesterone II

12145383

< 923 > 0.923 ↑

< 0.621 < 720 > 720 ↓

< 82 > 82 ↑

< 2000




Reagent type

Assay cat.no.


Hemolysis (HB

mmol/l)#


Biotin (nmol/l)

#


Dialysis

Hormones Prolactin II 03203093

< 513 < 0.932 < 1500 > 1500 ↓

< 164 < 1100

SHBG 03052001

< 1026 < 1.8 < 2700 < 246 < 1160

Testosterone II 05200067

< 513 < 0.372 < 1000 > 1000 ↓

< 123

< 1000

Diabetes C-Peptide 03184897

< 855 < 0.186 > 0.186 ↓

< 2000 < 246 < 1200

Insulin 12017547

< 1539 Hemolysis interferes, as insulin-degrading peptidases

are released

from erythrocytes

< 1800 < 246 < 18900 > 18900 ↑

Pree-clampsia

PlGF 05144671

< 428 < 0.311 < 1500

< 123 < 600

sFlt-1 05109523

< 427 < 0.311 < 1400 < 123 > 123 ↓

< 600




Reagent type

Assay cat.no.


Hemolysis (HB

mmol/l)#


Biotin (nmol/l)

#


Dialysis

Tumor Marker

AFP 04481798

< 1112 < 1.4 < 1500 < 246 < 1500

CA 125 II 11776223

< 1129 < 2.0 < 2000 < 143 > 143 ↓

< 1200

CA 15-3 II 03045838

< 1112 < 1.9 < 1500 < 409 < 1500

CA 19-9 11776193

< 1129 < 1.4 < 1500 < 409 > 409 ↓

< 1500

CA 72-4 11776258

< 1129 < 1.4 < 1500 < 246 > 246 ↓

< 1500

CEA 11731629

< 1129 < 1.4 < 1500 < 491 < 1500

Cyfra 21-1 11820966

< 1112 < 0.93 < 1500 < 205 < 1500

HE4 05950929

< 1130 < 0.621 < 2000 < 205 < 1500

NSE 12133113

< 1231 NSE in erythro-

cytes and platelets leads to elevated results in

hemolyzed samples

< 2000 < 409 < 1500




Reagent type

Assay cat.no.


Hemolysis (HB

mmol/l)#


Biotin (nmol/l)

#


Dialysis

Others

Tumor Marker

ProGRP 06505961

≤ 1130 < 0.621 ≤ 2000 ≤ 35 < 540 IgG ≤ 17 g/l IgM < 2.9 g/l IgA < 10 g/l Albumin <

200 g/l free PSA

03289788 < 1112 < 0.621 < 1500 < 123 < 1500

total PSA 04641655

< 1112 < 1.4 < 1500 < 246 < 1500

S 100 03175243

< 428 > 428 ↑

< 0.621 > 0.621 ↓

< 1500 > 1500 ↑

< 205 > 205 ↓

< 1000

Down’s Syndrome

free ßHCG 0484071

< 428 > 428 ↓

< 0.621 < 1500 < 123 < 1000

Screening PAPP-A 04854098

< 205 > 205 ↓

< 0.621 > 0.621 ↓

< 1500 < 123 > 123 ↓

< 1000




Reagent type

Assay cat.no.




Biotin (nmol/l)

#


Dialysis

Anaemia Vitamin B12 04745736

< 1112 < 0.621 < 1500 < 205 < 1500

Ferritin 03737551 04491785

< 1112 < 0.31 > 0.31 ↑

< 3300 < 205 < 2500

Folate III 04476433

< 564 > 564 ↑

Hemolysis may significantly

increase folate values due to high concentrations of folate in red blood cells. Therefore

hemolyzed samples are not suitable for use in this assay.

< 1500 < 21 > 21 ↓

< 1000

Folate RBC 05944295

< 564

- < 1500 < 21 < 1000




Assay cat.no.




Biotin (nmol/l)#


Dialysis

Others

Bone b-CrossLaps/ serum

11972308

< 1112 < 0.3 > 0.3 ↓

< 1500 < 368 > 368 ↓

< 1500

hGH 05390125

< 428 < 0.310 < 1500 < 123 < 600

N-MID Osteocalcin 12149133

< 1112 Erythrocytes contain proteases which

degrade osteocalcin

< 1500 < 205 < 2200

Total P1NP 03141071

< 1112 < 1.1 < 2000 < 205 > 205 ↓

< 2490

PTH 11972103

< 1112 < 0.09* > 0.09 ↓

< 1500 < 205 > 205 ↓

< 1500

PTH STAT 04892470

< 1112 < 0.155 < 1500 < 205 < 1500

PTH (1-84) 05608546

< 1112 < 0.062* < 1500 < 205 < 1500 IgG < 28 g/l IgM < 8 g/l IgA < 16 g/l

Albumin < 120 g/l

Vitamin D total 05894913

< 1129 < 0.124* > 0.124 ↑

< 400 < 287

-

Varia IgE II 04827031

< 633 < 0.06 > 0.06 ↓

< 2700 < 409 < 6000

* Samples showing visible signs of hemolysis may cause interference.




Assay cat.no.




Biotin (nmol/l)#


Dialysis

Others

Rheuma-toid Arthritis

Anti-CCP 05031656

< 427 > 427 ↓

< 0.311 < 1500 < 123 < 150

Sepsis BRAHMS PCT 05056888

< 428 < 0.559 < 1500 < 123 > 123 ↓

< 1500

IL-6 05109442

< 428 < 0.621 > 0.621 ↓

< 1500 < 123 > 123 ↓

< 1500

ISDs Cyclosporine 05889014

≤ 1026 - ≤ 1500 ≤ 123 < 500 IgG ≤ 12 g/l Albumin ≤ 12 g/l

Cholesterol ≤ 500 mg/dL

HAMA ≤ 50 µg/mL Hematokrit 15-60%

Uric acid ≤ 20 mg/dL Tacrolimus

05889057 ≤ 1026 - ≤ 1500 ≤ 123 < 500 IgG ≤ 12 g/l

Albumin ≤ 12 g/l Cholesterol ≤ 500

mg/dL HASA ≤ 10 µg/mL Hematokrit 15-60%

Uric acid ≤ 20 mg/dL




Assay cat.no.




Biotin (nmol/l)

#


Dialysis

Hepatits Anti-HAV 11820605

< 855 < 0.745 > 0.745 ↓

< 1000 > 1000 ↓

< 205 < 1600

Anti-HAV IgM 11820591

< 855 < 1.09 < 2000 < 205 < 3200

Anti-HBc 11820559

< 428 < 1.0 > 1.0 ↓

< 1000 < 123 > 123 ↓

< 676 > 676 ↓

Anti-HBc IgM 11820567

< 428 < 1.2 < 1500 < 409 < 4200

Anti-HBe 11820613

< 85.5 > 85.5 ↓

< 1.2 < 1500 < 409 < 2400

HBeAg 11820583

< 428 < 0.99 > 0.99 ↑

< 1500 < 164 > 164 ↑

< 2400

Anti-HBs 11820524

< 513 > 513 ↓

< 0.93 < 1500 < 123 > 123 ↓

< 2100 > 2100 ↓

HBsAg II 04687787

< 684 < 1.24 > 1.24 ↓

< 2000 < 164 > 164 ↓

< 6210

HBsAg II quant 05957435

< 684 < 0.311 < 2000 < 164

< 1200

Anti-HCV II 06368921

< 1129 < 0.621 < 2000 < 172 < 1200



Reagent type

Assay cat.no.




Biotin (nmol/l)

#


Dialysis

Others

Sexually transmitted diseases (STD)

HIV antigen 11971611

< 428 < 1.2 < 1500 < 409 < 2400

HIV combi PT

05390095

< 1026 < 0.31 < 1500 < 123 < 1500

Syphilis 06923348

≤ 1129 ≤ 0.310 ≤ 2000 ≤ 246 < 1500 Human serum albumin ≤ 100 g / dl

Human IgG ≤ 32 g/l Human IgM ≤ 10 g/l Human IgA ≤ 2 g /dl




Assay cat.no.




Biotin (nmol/l)

#


Dialysis

Torch CMV IgG 04784596

<1129 < 0.31 < 2000 < 246 < 1500

CMV IgG Avidity

05909708

< 1129 < 0.31 < 2000 < 246 < 1500

CMV IgM 04784618

< 342 < 0.31 < 1500 < 410 < 2000

HSV-1 IgG 05572185

<1130 <0.621 <2000 <205 <1500

HSV-2 IgG 05572193

<1130 <0.621 <2000 <205 <1500

Rubella IgG 04618793

< 513 < 3.47 < 1500 < 205 < 6210

Rubella IgM 04618831

< 428 < 1.49 < 1500 < 205 < 6210

Toxo IgG 04618815

< 684 < 1.24 < 2000 < 246 < 6210

Toxo IgG Avidity

05802571

< 684 < 1.24 < 2000 < 246 < 6210

Toxo IgM 04618858

< 684 < 1.24 < 2000 < 246 < 3720



# Criterion: recovery within +/- 10% of initial value, when no other information is stated in the corresponding method sheet. Ë Please refer to method sheet whether Intralipid or tryglycerides have been used for interference testing of the Assay.



Used Documents: Assay Method Sheet FT3 III 1212/01 FT4 II 1212/01 T3 0811/20 T4 1011/16 TSH 0911/20 T-uptake 1111/18 Calcitonin 0213/01 Tg II 0313/01 Anti-Tg 0911/02 Anti-TPO 0811/02 Anti-TSHR 0911/09 CK-MB 0812/03 Myoglobin 0812/14 proBNP II 0512/07 Troponin I 0712/05 Troponin T hs STAT 0512/07 Digoxin 0512/18 Digitoxin 0612/11 HCG STAT 0412/15 HCG+b 0412/15 ACTH 1211/07 AMH 0714/01 Cortisol 0512/08 DHEA-S 0912/16 Estradiol II 0312/02 FSH 0412/18 LH 0412/18 Progesterone II 0712/15



Used Documents: Assay Package insert Prolactin II 0312/05 SHBG 0512/10 Testosterone II 0512/06 C-Peptide 0412/08 Insulin 0412/13 PlGF 0512/05 sFlt-1 0512/05 AFP 0911/10 CA 125 II 0412/15 CA 15-3 II 0512/16 CA 19-9 0911/20 CA 72-4 0312/10 CEA 0512/20 Cyfra 21-1 0812/15 HE4 0612/05 NSE 0812/11 ProGRP 0913/01 free PSA 0211/10 total PSA 0510/07 S100 0510/07 Free ßhCG 0812/06 PAPP-A 0411/03 Vitamin B12 0112/10 Ferritin 0312/12 Folate III 0712/10 Folate RBC 1011/01 IgE II 0312/06 b-CrossLaps/serum 1211/12 hGH 0211/02



Used Documents: Assay Package insert N-MID Osteocalcin 1211/14 PTH 1012/22 PTH STAT 1211/01 PTH (1-84) 1012/02 Total P1NP 0812/09 Vitamin D total 0812/04 Anti-CCP 0611/04 BRAHMS PCT 0712/07 IL-6 0512/05 Cyclosporine 0913/01 Tacrolimus 0913/02 Anti-HAV 0712/09 Anti-HAV IgM 1012/12 Anti-HBc 0610/20 Anti-HBc IgM 0212/14 Anti-HBe 0610/13 HBeAg 0610/15 Anti-HBs 0610/16 HBsAg II 1112/11 HBsAg II quant 0111/02 Anti-HCV II 1112/02 HIV Ag 0712/11 HIV combi PT 1212/03 Syphilis 0114/01 CMV IgG 1012/06 CMV IgG Avidity 0712/03 CMV IgM 0712/05 HSV-1 IgG 1211/02



HSV-2 IgG 1211/02



Assay Package insert Rubella IgG 1012/06 Rubella IgM 1012/07 Toxo IgG 0612/10 Toxo IgG Avidity 0712/03 Toxo IgM 1211/07 For this document are the contents of the current ElecsysÒ method sheets used. The used method sheet versions are listed above. Original datas are available in the corresponding method sheets.