SERO
SERO
SERO
The independent control sera specialist since 1963.
SERO is a Norwegian expertise-based biotechnology company manufacturing and marketing quality control materials worldwide. SERO has been a pioneer in the field of QC materials for laboratories. SERO’s founder, Professor Dr Med. Lorentz Eldjarn, started developing control sera as early as in the 1950s. Professor Eldjarn’s extensive professional knowledge and passionate interest in laboratory quality led to the establishment of SERO in 1963. In 1975, he received the Clinical Chemistry Award from the IFCC (International Federation of Clinical Chemistry).
Accelerated stability studies are widely used in pharmaceuticals and in vitro diagnostics (IVD) to predict product shelf-life. Based on the Arrhenius equation, these tests assume that degradation rates double for every 10°C increase in temperature. But is that assumption valid for complex biomolecules like enzymes and proteins in serum controls? In this article, we explore how accelerated stability testing can sometimes misrepresent real-world product performance — and how to interpret these results wisely.
The Problem: Non-linear Behavior in Real-World Conditions
Many assume that results from high-temperature storage can be linearly extrapolated to normal storage conditions (typically +2 to +8 °C). However, this is often not the case for biological materials like serum-based quality controls. Why? Because biomarkers don’t always behave predictably under heat stress. Elevated temperatures can trigger molecular changes – such as protein denaturation, enzyme inactivation, or light-induced degradation – that don’t occur under recommended storage conditions. This can lead to:
- False negatives: assuming a product won’t meet shelf-life requirements when it actually does.
- Poor decisions: discarding stable biomarker sources or altering formulations unnecessarily.
Study Insights: What We Observed at SERO
We conducted a series of accelerated (+20 and +30 °C) and real-time (+4 °C) stability studies on lyophilized clinical chemistry (CC) and cardiac immunoassay (IA) control materials.
Here’s what stood out:
Mismatch Between Accelerated and Real-Time Stability
- Biomarkers like ALT, AST, ALP, LDH, CK, glucose, and bilirubin failed accelerated testing – but were stable for 4 years at +4 °C.
- In contrast, creatinine and total protein showed consistent stability in both settings.
🔹 Cardiac Immunoassay Controls
- 8 out of 15 markers failed accelerated testing.
- Yet all passed real-time testing over a 3-year period.
Key Takeaways for Labs and Manufacturers
Don’t Rely on Q10 Alone
The common Q10 = 2 rule oversimplifies degradation in biological systems. Protein folding, enzyme activity, and oxidation are not purely temperature-driven.
Use Accelerated Studies for What They Are Good At
- Identifying vulnerable biomarkers early in development
- Screening alternative sources (e.g. PTH variants)
- Monitoring lot-to-lot consistency or formulation changes
- Investigating transport-related temperature excursions
Always Validate with Real-Time Data
Accelerated testing is valuable – but only when supported by long-term, real-time data. Relying on one without the other risks underestimating product performance.
Conclusion
Accelerated stability studies can’t fully predict the shelf-life of serum-based control materials, but they can guide smarter decisions when used correctly. Understanding the non-linear behavior of biomarkers is essential for developing robust, reliable IVD controls.
Products
Immunoassay (5)
Seronorm®
Immunoassay Liq
Lab’s Best Friend – All your essential immunoassay tests in one reliable liquid control. Integrates a broad spectrum of immunoassay analytes including hormones, cardiac, fertility, and cancer markers for comprehensive testing. Extensive documentation for a diversity of plattforms.
17-OH-Progesterone, 25-OH-Vitamin D, total 25-OH-Vitamin D3, AFP Aldosterone, AMH, Androstenedione, Anti-Tg, Anti-TPO, β2-microglobulin, β-hCG, total CA 125, CA 15-3, CA 19-9, CEA, CK-MB, Cortisol, C-peptide, DHEA-Sulfate, Digoxin, EPO, Estradiol, Ferritin, Folate, FSH, hCG, total HE4, hGH, Homocysteine, IgE IGFBP-3, IGF-1, Insulin LH, Methylmalonic acid, Myoglobin, NT-proBNP, Ostase, Progesterone, Prolactin, Prostatic acid, phosphatase PSA, complexed PSA, free PSA, total PTH, intact SHBG T3, free T3, total T4, free T4, total TBG Testosterone Theophylline Thyroglobulin Troponin I Troponin T TSH Vitamin B12.
Human – 3 Levels – Extensive documentation – Bestseller
Seronorm®
Immunoassay Lyo
Lab’s Best Friend — All your essential immunoassay tests in one reliable lyophilized control. Integrates a broad spectrum of immunoassay analytes including hormones, cardiac markers, fertility, and cancer markers for comprehensive testing. Extensive documentation for a diversity of plattforms.
17-OH-Progesterone, 25-OH-Vitamin D, total 25-OH-Vitamin D3, AFP Aldosterone, AMH, Androstenedione, Anti-Tg, Anti-TPO, β2-microglobulin, β-hCG, total CA 125, CA 15-3, CA 19-9, CEA, CK-MB, Cortisol, C-peptide, DHEA-Sulfate, Digoxin, EPO, Estradiol, Ferritin, Folate, FSH, hCG, total HE4, hGH, Homocysteine, IgE IGFBP-3, IGF-1, Insulin LH, Methylmalonic acid, Myoglobin, NT-proBNP, Ostase, Progesterone, Prolactin, Prostatic acid, phosphatase PSA, complexed PSA, free PSA, total PTH, intact SHBG T3, free T3, total T4, free T4, total TBG Testosterone Theophylline Thyroglobulin Troponin I Troponin T TSH Vitamin B12.
Human – 3 Levels
Autonorm®
Immunoassay Lyo
All your essential immunoassay tests in one reliable liquid control. Integrates a broad spectrum of immunoassay markers including hormones, cardiac markers, fertility, and cancer markers for comprehensive testing. Limited documentation for users setting their own target values.
AFP, AMH, Anti-Tg, Anti-TPO, β-hCG, total, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, Cortisol, C-peptide, DHEA-Sulfate, Digoxin, EPO, Estradiol, Ferritin, Folate, FSH, hGH, Homocysteine, IgE, total, Insulin, LH, Myoglobin, NT-proBNP, Ostase, Progesterone, Prolactin, PSA, free, PSA, total, PTH, intact, SHBG, T3, free, T3, total, T4, free, T4, total, Testosterone, Thyroglobulin, Troponin I, TSH, Vitamin B12, 25-OH-Vitamin D, total.
Human – 3 Levels
Autonorm®
Immunoassay Liq
Lab’s Best Friend – All your essential immunoassay tests in one reliable liquid control. Integrates a broad spectrum of immunoassay analytes including hormones, cardiac, fertility, and cancer markers for comprehensive testing. Extensive documentation for a diversity of plattforms.
17-OH-Progesterone, AFP, Aldosterone, AMH, Androstenedione, Anti-Tg, Anti-TPO, β2-microglobulin, β-hCG, total, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, Cortisol, C-peptide, DHEA-Sulfate, Digoxin, EPO, Estradiol, Ferritin, Folate, FSH, HE4, hGH, Homocysteine, IgE, total, IGF-1, Insulin, LH, Methylmalonic acid, Myoglobin, NT-proBNP, Progesterone, Prolactin, Prostatic acid phosphatase, PSA, free, PSA, total, PTH, intact, SHBG, T3, free, T3, total, T4, free, T4, total, TBG, Testosterone, Theophylline, Thyroglobulin, Troponin I, Troponin T, TSH, Vitamin B12, 25-OH-Vitamin D, total.
Human – 3 Levels
Seronorm®
Immunoassay Liq Low
Immunoassay Liq LowAn additional fourth lower level of Seronorm® Immunoassay. This product complements Seronorm® Immunoassay with clinically relevant low levels of selcted analytes.
17-OH-Progesterone 25-OH-Vitamin D, total 25-OH-Vitamin D3 Aldosterone Androstenedione Cortisol Ferritin IgE PSA, total T4, free TBG Testosterone TSH Vitamin B12.
Human
Clinical Chemistry (3)
Seronorm®
Urine
Ready from the Fridge’ — Ensuring accurate analysis with a stable, ready-to-use human urine control for a wide range of analytes.
Albumin/Creatinine quota, Amylase, Calcium, Chloride, Cortisol, free, Creatinine, Glucose, Magnesium, Microalbumin, Osmolality, pH, Phosphorus, Potassium, Pregnancy, Protein, total, Sodium, Specific gravity, Urea, Uric Acid.
Human – 2 Levels – Urine
Seronorm®
Human
Lab Lifeline – A multi-component control crafted from human serum for precision and accuracy across a wide range of analyses.
ALAT, Albumin, ALP, Amylase, pancreas, Amylase, total, Apolipoprotein A1, Apolipoprotein B, ASAT, Bile Acid, Bile acid, Bilirubin, direct, Bilirubin, total, Calcium, Chloride, Cholesterol, HDL, Cholesterol, LDL, Cholesterol, total, Cholinesterase, CK, CK-MB, Copper, Creatinine, CRP, Digoxin, GGT, GLDH, Glucose, HBDH, IgA, IgG, IgM, Iron, Lactate, LDH, Lipase, Lithium, Magnesium, NEFA, Osmolality, Phosphorus, Potassium, Protein, total, Sodium, Theophylline, Transferrin, Triglycerides, UIBC, Urea, Uric Acid, Zinc.
Human – 3 Levels – Lyophilized
Autonorm®
Clin Chem Liq
Your all-in-one chemistry solution. Includes a broad spectrum of clinical chemistry analytes, lipids, enzymes, proteins, hormones, cardiac markers, bicarbonate and several therapeutic drugs for all-encompassing testing.
α1-acid-glycoprotein, α1-antitrypsin, α2-macroglobulin, ALAT, Albumin, ALP, Amikacin, Amylase, pancreas, Amylase, total, Apolipoprotein A1, Apolipoprotein B, ASAT, ASO, Bicarbonate, Bile acid, Bile Acid, Bilirubin, direct, Bilirubin, total, C3c, C4, Calcium, Carbamazepine, Ceruloplasmin, Chloride, Cholesterol, HDL, Cholesterol, LDL, Cholesterol, total, Cholinesterase, CK, total, CK-MB, Copper, Creatinine, CRP, Digoxin, Ethanol, Ferritin, Gentamicin, GGT, Glucose, Haptoglobin, IgA, IgG, IgM, Iron, Lactate, LDH, Lipase, Lithium, Magnesium, Methotrexate, Osmolality, Paracetamol, Phenobarbitone, Phenytoin, Phosphorus, Potassium, Prealbumin, Protein, total, Quinidine, Salicylate, Sodium, Theophylline, TIBC, Tobramycin, Transferrin, Triglycerides, UIBC, Urea, Urea Nitrogen, Uric Acid, Valproic Acid, Vancomycin, Zinc.
Human – 3 Levels
Cardiac and Acute Markers (4)
Seronorm®
Cardiac Acute Lyo
The Critical Care Companion — Integrating a full panel of cardiac and acute markers for swift, life-saving diagnostics.
BNP, β-hCG, total, CK, total, CK-MB, CRP, D-dimer, Digoxin, hCG, total, Homocysteine, IL-6, Myoglobin, NT-proBNP, Procalcitonin, S-100 beta, Troponin I, Troponin T.
Human – 4 Levels – News
Seronorm®
Immunoassay Liq
Lab’s Best Friend – All your essential immunoassay tests in one reliable liquid control. Integrates a broad spectrum of immunoassay analytes including hormones, cardiac, fertility, and cancer markers for comprehensive testing. Extensive documentation for a diversity of plattforms.
17-OH-Progesterone, 25-OH-Vitamin D, total, 25-OH-Vitamin D3, AFP, Aldosterone, AMH, Androstenedione, Anti-Tg, Anti-TPO, β2-microglobulin, β-hCG, total, CA 125, CA 15-3, CA 19-9, CEA, CK-MB, Cortisol, C-peptide, DHEA-Sulfate, Digoxin, EPO, Estradiol, Ferritin, Folate, FSH, hCG, total, HE4, hGH, Homocysteine, IgE, IGFBP-3, IGF-1, Insulin, LH, Methylmalonic acid, Myoglobin, NT-proBNP, Ostase, Progesterone, Prolactin, Prostatic acid phosphatase, PSA, complexed, PSA, free, PSA, total, PTH, intact, SHBG, T3, free, T3, total, T4, free, T4, total, TBG, Testosterone, Theophylline, Thyroglobulin, Troponin I, Troponin T, TSH, Vitamin B12.
Human – 3 Levels – Extensive documentation – Bestseller
Seronorm®
Cardiac Acute Liq
The Critical Care Companion – Integrating a full panel of cardiac and acute markers for swift, life-saving diagnostics. Extensive documentation for a diversity of plattforms.
BNP, β-hCG, total, CK, total, CK-MB, CRP, D-dimer, Digoxin, hCG, total, Homocysteine, IL-6, Myoglobin, NT-proBNP, Procalcitonin, S-100 beta, Troponin I, Troponin T.
Human – 4 Levels – Extensive documentation – Popular
Seronorm®
Immunoassay Lyo
Lab’s Best Friend – All your essential immunoassay tests in one reliable lyophilized control. Integrates a broad spectrum of immunoassay analytes including hormones, cardiac markers, fertility, and cancer markers for comprehensive testing. Extensive documentation for a diversity of plattforms.
17-OH-Progesterone, 25-OH-Vitamin D, total 25-OH-Vitamin D3, AFP Aldosterone, AMH, Androstenedione, Anti-Tg, Anti-TPO, β2-microglobulin, β-hCG, total CA 125, CA 15-3, CA 19-9, CEA, CK-MB, Cortisol, C-peptide, DHEA-Sulfate, Digoxin, EPO, Estradiol, Ferritin, Folate, FSH, hCG, total HE4, hGH, Homocysteine, IgE IGFBP-3, IGF-1, Insulin LH, Methylmalonic acid, Myoglobin, NT-proBNP, Ostase, Progesterone, Prolactin, Prostatic acid, phosphatase PSA, complexed PSA, free PSA, total PTH, intact SHBG T3, free T3, total T4, free T4, total TBG Testosterone Theophylline Thyroglobulin Troponin I Troponin T TSH Vitamin B12.
Human – 3 Levels
Proteins (3)
Seronorm®
Immunoprotein Lyo
Protein Powerhouse – Expertly crafted for comprehensive immunoprotein testing. Contains over 20 crucial proteins including Cystatin C, anti-CCP, RF, Digitoxin and high CRP, covering a broad spectrum of immunodiagnostic needs.
α1-acid-glycoprotein, α1-antitrypsin, α2-macroglobulin, Albumin, Anti-CCP, Apolipoprotein A1, ASL, β2-microglobulin, C3c, C4, Ceruloplasmin, CRP, Cystatin C, Digitoxin, Ferritin, Haptoglobin, IgA, IgE, IgG, IgM, Myoglobin, Prealbumin, Protein, total, RF, Transferrin, Electrophoresis.
Human – 2 Levels – Lyophilized
Seronorm®
CRP Liquid
Top-quality CRP control, ready from the fridge. Five year long-term stability. Values provided for both laboratory and Point-of-Care instrumentation.
CRP.
Human – 3 Levels
Seronorm®
Immunoprotein Liq
Protein Powerhouse – Expertly crafted for comprehensive immunoprotein testing. Contains over 20 crucial proteins including Cystatin C, anti-CCP, RF, Digitoxin and high CRP, covering a broad spectrum of immunodiagnostic needs.
α1-acid-glycoprotein, α1-antitrypsin, α2-macroglobulin, Albumin, Anti-CCP, Apolipoprotein A1, ASL, β2-microglobulin, C3c, C4, Ceruloplasmin, CRP, Cystatin C, Digitoxin, Ferritin, Haptoglobin, IgA, IgE, IgG, IgM, Myoglobin, Prealbumin, Protein, total, RF, Transferrin, Electrophoresis.
Human – 2 Levels
Newborn (1)
Seronorm®
Paediatric
Specially made for the newborn with high Bilirubin levels.
ALP, Bilirubin, direct, Bilirubin, indirect, Bilirubin, total, Calcium, Chloride, Glucose, Magnesium, Phosphorus, Potassium, Sodium.
Human – Lyophilized
Diabetes (1)
Seronorm®
HbA1c Liquid
Your ethically produced HbA1c control for diabetic monitoring. Created via in-vitro glycation of human blood from healthy donors.
HbA1c.
Human – 2 Levels
Urine (2)
Seronorm®
Urine
Ready from the Fridge – Ensuring accurate analysis with a stable, ready-to-use human urine control for a wide range of analytes.
Albumin/Creatinine quota, Amylase, Calcium, Chloride, Cortisol, free, Creatinine, Glucose, Magnesium, Microalbumin, Osmolality, pH, Phosphorus, Potassium, Pregnancy, Protein, total, Sodium, Specific gravity, Urea, Uric Acid.
Human – 2 Levels – Urine
Seronorm®
Trace Elements Urine
Trusted Accuracy for each element. Used in a wide variety of appications such as nutrition, occupational health, environmental health, toxicology, food safety, veterinary and biological studies. Contains over 60 different elements.
Aluminium, Antimony, Arsenic, Beryllium, Cadmium, Chromium, Cobalt, Copper, Fluoride, Iodine, Iron, Lead, Magnesium, Manganese, Mercury, Molybdenum, Nickel, Selenium, Tellurium, Thallium, Tin, Vanadium, Zinc.
Human – 2 Levels – Urine
Trace Elements (6)
Seronorm®
Trace Elements Urine RUO
Trusted Accuracy for each element. Used in a wide variety of appications such as nutrition, occupational health, environmental health, toxicology, food safety, veterinary and biological studies. Contains over 60 different elements. This Research Use Only product is not intended to be used for medical in vitro diagnostic (IVD) purposes.
Aluminium, Antimony, Arsenic, Beryllium, Cadmium, Chromium, Cobalt, Copper, Fluoride, Iodine, Iron, Lead, Magnesium, Manganese, Mercury, Molybdenum, Nickel, Selenium, Tellurium, Thallium, Tin, Vanadium, Zinc.
Urine – 2 Levels
Seronorm®
Trace Elements Whole Blood RUO
Trusted Accuracy for each element. Used in a wide variety of appications such as nutrition, occupational health, environmental health, toxicology, food safety, veterinary and biological studies. Contains over 60 different elements. This Research Use Only product is not intended to be used for medical in vitro diagnostic (IVD) purposes.
Aluminium, Antimony, Arsenic, Beryllium, Bismuth, Cadmium, Calcium, Chromium, Cobalt, Copper, Fluoride, Iodine, Lead, Lithium, Magnesium, Manganese, Mercury, Methyl Mercury, Molybdenum, Nickel, Selenium, Silver, Strontium, Thallium, Tin, Vanadium, Zinc.
3 Levels – Human
Seronorm®
Trace Elements Serum RUO
Trusted Accuracy for each element. Used in a wide variety of appications such as nutrition, occupational health, environmental health, toxicology, food safety, veterinary and biological studies. Contains over 60 different elements. This Research Use Only product is not intended to be used for medical in vitro diagnostic (IVD) purposes.
Aluminium, Calcium, Chromium, Cobalt, Copper, Fluoride, Iron, Lithium, Magnesium, Manganese, Mercury, Nickel, Phosphorus, Potassium, Selenium, Sodium, Zinc.
Human – Lyophilized
Seronorm®
Trace Elements Whole Blood
Trusted Accuracy for each element. Used in a wide variety of appications such as nutrition, occupational health, environmental health, toxicology, food safety, veterinary and biological studies. Contains over 60 different elements.
Aluminium, Antimony, Arsenic, Beryllium, Bismuth, Cadmium, Calcium, Chromium, Cobalt, Copper, Fluoride, Iodine, Lead, Lithium, Magnesium, Manganese, Mercury, Methyl Mercury, Molybdenum, Nickel, Selenium, Silver, Strontium, Thallium, Tin, Vanadium, Zinc.
Human – 3 Levels
Seronorm®
Trace Elements Urine
Trusted Accuracy for each element. Used in a wide variety of appications such as nutrition, occupational health, environmental health, toxicology, food safety, veterinary and biological studies. Contains over 60 different elements.
Aluminium, Antimony, Arsenic, Beryllium, Cadmium, Chromium, Cobalt, Copper, Fluoride, Iodine, Iron, Lead, Magnesium, Manganese, Mercury, Molybdenum, Nickel, Selenium, Tellurium, Thallium, Tin, Vanadium, Zinc.
Human – 2 Levels – Urine
Seronorm®
Trace Elements Serum
Trusted Accuracy for each element. Used in a wide variety of appications such as nutrition, occupational health, environmental health, toxicology, food safety, veterinary and biological studies. Contains over 60 different elements.
Aluminium, Calcium, Chromium, Cobalt, Copper, Fluoride, Iron, Lithium, Magnesium, Manganese, Mercury, Nickel, Phosphorus, Potassium, Selenium, Sodium, Zinc.
Human – 2 Levels
Therapeutic Drugs (2)
Autonorm®
Clin Chem Liq
Your all-in-one chemistry solution. Includes a broad spectrum of clinical chemistry analytes, lipids, enzymes, proteins, hormones, cardiac markers, bicarbonate and several therapeutic drugs for all-encompassing testing.
α1-acid-glycoprotein, α1-antitrypsin, α2-macroglobulin, ALAT, Albumin, ALP, Amikacin, Amylase, pancreas, Amylase, total, Apolipoprotein A1, Apolipoprotein B, ASAT, ASO, Bicarbonate, Bile acid, Bile Acid, Bilirubin, direct, Bilirubin, total, C3c, C4, Calcium, Carbamazepine, Ceruloplasmin, Chloride, Cholesterol, HDL, Cholesterol, LDL, Cholesterol, total, Cholinesterase, CK, total, CK-MB, Copper, Creatinine, CRP, Digoxin, Ethanol, Ferritin, Gentamicin, GGT, Glucose, Haptoglobin, IgA, IgG, IgM, Iron, Lactate, LDH, Lipase, Lithium, Magnesium, Methotrexate, Osmolality, Paracetamol, Phenobarbitone, Phenytoin, Phosphorus, Potassium, Prealbumin, Protein, total, Quinidine, Salicylate, Sodium, Theophylline, TIBC, Tobramycin, Transferrin, Triglycerides, UIBC, Urea, Urea Nitrogen, Uric Acid, Valproic Acid, Vancomycin, Zinc.
Human – 3 Levels
Autonorm®
Pharmaca Liq
Pharmacy in a bottle. Contains more than 20 drugs covering a wide range of therapeutic areas.
Amikacin, Carbamazepine, Clonazepam, Cyclosporine, Diazepam, Digoxin, Gentamycine, Haloperidol, Lamotrigine, Levetiracetam, Lithium, Methotrexate, Paracetamol, Phenobarbitone, Phenytoin, Teicoplanin, Theophylline, Tobramycin, Topiramate, Valproic Acid, Vancomycin, Zonisamide.
Human – 2 Levels