Skip to content

Technical Specification: Hepatotoxicity & Clinical Chemistry Assay Kits

Official Source Verification

This documentation is published by Beijing Solarbio Science & Technology Co., Ltd. For product procurement and commercial inquiries, visit the Solarbio Store.

1. Product Range

Assay SKU Principle Wavelength Detection Limit Linear Range Sample Types
ALT (GPT) BC1550 Reitman-Frankel (2,4-DNPH) 505 nm 1 U/L 2–150 U/L Serum, plasma
AST (GOT) BC1560 Reitman-Frankel (2,4-DNPH) 505 nm 2 U/L 5–200 U/L Serum, plasma
ALP BC2140 pNPP hydrolysis (kinetic) 405 nm 1 U/L 3–500 U/L Serum, plasma
γ-GT (GGT) BC1225 L-γ-glutamyl-p-nitroanilide 405 nm 0.5 U/L 2–300 U/L Serum, plasma
LDH BC0680 NADH → NAD⁺ (kinetic, UV) 340 nm (↓A) 2 U/L 5–600 U/L Serum, cell lysate, tissue
5′-Nucleotidase (5′-NT) BC1230 Adenosine → NH₃ detection 640 nm 0.5 U/L 1–100 U/L Serum, plasma
Creatinine BC4780 Jaffe reaction (picric acid, alkaline) 510 nm 5 μmol/L 10–500 μmol/L Serum, plasma, urine
BUN (Urea) BC1520 Urease-indophenol (Berthelot) 630 nm 0.5 mmol/L 1–25 mmol/L Serum, plasma
Total Protein BC3740 Biuret method 540 nm 0.1 g/L 0.5–100 g/L Serum, plasma
Total Bilirubin BC1800 Diazotized sulfanilic acid (Jendrassik-Grof) 540 nm 1 μmol/L 2–200 μmol/L Serum, plasma

2. Detailed Assay Principles and Reaction Equations

2.1 ALT (Alanine Aminotransferase / GPT) — Reitman-Frankel Method

ALT catalyzes the transfer of an amino group from L-alanine to α-ketoglutarate, producing pyruvate and L-glutamate. Pyruvate reacts with 2,4-dinitrophenylhydrazine (DNPH) to form a hydrazone chromophore in alkaline solution.

L-Alanine + α-Ketoglutarate ──[ALT (pH 7.4, 37°C)]──→ Pyruvate + L-Glutamate

Pyruvate + DNPH (2,4-dinitrophenylhydrazine)
    ──[Alkaline]──→ Pyruvate-2,4-dinitrophenylhydrazone (brown, 505 nm)
Parameter Specification
Substrate L-Alanine (200 mM) + α-KG (2 mM) in PBS, pH 7.4
Incubation 30 min at 37°C
DNPH incubation 2,4-DNPH (0.1% in 1 M HCl), 20 min at 37°C
Alkaline development 0.4 M NaOH, 10 min at RT
Wavelength 505 nm
Detection limit 1 U/L
Linear range 2–150 U/L
Intra-assay CV <5% (n=20, 50 U/L)
Inter-assay CV <10% (n=10 lots)
Sample volume 50 μL
Calibrator 50 U/L pyruvate calibrator (included)
Unit definition 1 U = 1 μmol pyruvate formed per min at 37°C

2.2 AST (Aspartate Aminotransferase / GOT) — Reitman-Frankel Method

AST transfers an amino group from L-aspartate to α-ketoglutarate, producing oxaloacetate (OAA) and L-glutamate. OAA is unstable and spontaneously decarboxylates to pyruvate, which is detected with DNPH.

L-Aspartate + α-Ketoglutarate ──[AST (pH 7.4, 37°C)]──→ Oxaloacetate + L-Glutamate

Oxaloacetate (spontaneous) → Pyruvate + CO₂

Pyruvate + DNPH → Pyruvate-2,4-dinitrophenylhydrazone (505 nm)
Parameter Specification
Substrate L-Aspartate (200 mM) + α-KG (2 mM)
Incubation 30 min at 37°C
Detection limit 2 U/L
Linear range 5–200 U/L
Intra-assay CV <5%
Calibrator Included (50 U/L)

ALT and AST Clinical Interpretation:

AST/ALT Ratio Condition
<1 (ALT > AST) Acute viral hepatitis, NAFLD
>1.5 (AST > ALT) Alcoholic hepatitis, cirrhosis
>2 (AST 2–20× ALT) Alcoholic liver disease
ALT > 300 U/L Consider drug-induced liver injury (DILI)
Both > 1000 U/L Massive hepatic necrosis, acetaminophen overdose

2.3 ALP (Alkaline Phosphatase) — pNPP Method

ALP hydrolyzes p-nitrophenyl phosphate (pNPP) to p-nitrophenol and inorganic phosphate. The reaction is performed at pH 10.3 (2-amino-2-methyl-1-propanol buffer) and stopped with NaOH.

pNPP (colorless) + H₂O ──[ALP, pH 10.3, 37°C]──→ p-Nitrophenol (yellow, 405 nm) + Pi
Parameter Specification
Substrate pNPP (10 mM in AMP buffer, pH 10.3)
Incubation 30 min at 37°C
Stop 0.1 M NaOH
Wavelength 405 nm
Detection limit 1 U/L
Linear range 3–500 U/L
Intra-assay CV <4%
Unit definition 1 U = 1 μmol pNPP hydrolyzed per min

Isoform Note: ALP exists as tissue-specific isoforms (liver/bone/kidney, intestinal, placental). Elevated liver ALP indicates cholestasis. For bone-specific ALP, heat inactivation at 56°C for 15 min selectively inactivates bone ALP by ~50%.

2.4 γ-GT (Gamma-Glutamyl Transferase / GGT)

GGT transfers the γ-glutamyl group from L-γ-glutamyl-p-nitroanilide to glycylglycine, releasing p-nitroaniline (yellow).

L-γ-Glutamyl-p-nitroanilide + Glycylglycine
    ──[GGT pH 8.6, 37°C]──→ L-γ-Glutamyl-Glycylglycine + p-Nitroaniline (yellow, 405 nm)
Parameter Specification
Substrate L-γ-Glutamyl-p-nitroanilide (4 mM)
Acceptor Glycylglycine (50 mM)
Buffer Tris-HCl, pH 8.6
Wavelength 405 nm
Detection limit 0.5 U/L
Linear range 2–300 U/L
Intra-assay CV <4%
Unit definition 1 U = 1 μmol p-nitroaniline formed per min

Clinical Note: GGT is the most sensitive marker for alcohol-induced hepatotoxicity. Elevated GGT with normal ALP suggests chronic alcohol consumption; elevation of both GGT and ALP indicates cholestasis.

2.5 LDH (Lactate Dehydrogenase) — Kinetic UV Method

LDH catalyzes reversible conversion of lactate to pyruvate with NAD⁺/NADH as cofactor. The kit measures the forward reaction (lactate → pyruvate), detected as NADH production (↑A₃₄₀).

L-Lactate + NAD⁺ ──[LDH, pH 9.0, 37°C]──→ Pyruvate + NADH + H⁺
(NADH production monitored at 340 nm, ↑A)
Parameter Specification
Assay type Kinetic (endpoint reading or rate)
Wavelength 340 nm
Detection limit 2 U/L
Linear range 5–600 U/L
Intra-assay CV <5%
Sample volume 20–50 μL
Unit definition 1 U = 1 μmol NADH formed per min at 37°C
ε (NADH) 6.22 × 10³ L·mol⁻¹·cm⁻¹

LDH Isoenzyme Distribution:

Isoenzyme Tissue Origin Clinical Significance
LDH-1 (H₄) Heart, RBC Elevated in MI, hemolysis
LDH-2 (H₃M) Heart, RBC Dominant in serum normally
LDH-3 (H₂M₂) Lung, spleen Elevation in pulmonary disease
LDH-4 (HM₃) Liver, skeletal muscle Hepatocellular injury
LDH-5 (M₄) Skeletal muscle, liver Liver disease, muscle damage

LDH-1/LDH-2 ratio >1 is a classic pattern for acute myocardial infarction (the "flipped" ratio).

2.6 5′-Nucleotidase (5′-NT)

5′-NT hydrolyses adenosine monophosphate (AMP) to adenosine and inorganic phosphate. The phosphate is detected via the molybdenum blue method.

Adenosine-5′-monophosphate + H₂O ──[5′-NT, pH 7.5, 37°C]──→ Adenosine + Pi

Pi + (NH₄)₂MoO₄ + Reducing agent → Molybdenum blue (640 nm)
Parameter Specification
Detection limit 0.5 U/L
Linear range 1–100 U/L
Intra-assay CV <6%

Clinical Note: 5′-NT is specific for hepatobiliary diseases. Unlike ALP, it is not elevated in bone disease, making it useful for distinguishing hepatic versus bone-origin ALP elevations.

2.7 Creatinine — Jaffe Reaction

Creatinine reacts with picric acid in alkaline solution to form an orange-red complex.

Creatinine + Picric acid ──[NaOH, pH ~12]──→ Creatinine-picrate complex (orange-red, 510 nm)
Parameter Specification
Wavelength 510 nm
Detection limit 5 μmol/L
Linear range 10–500 μmol/L
Intra-assay CV <5% (n=20, 100 μmol/L)
Inter-assay CV <10%
Deproteinization Required (tungstic acid precipitation included)
Reaction time 15 min at RT
Interference Ketone bodies, glucose (>20 mmol/L), cephalosporins — auto-blank correction included

Critical Notes: - Serum creatinine reference: 44–106 μmol/L (human). Rodents: 15–40 μmol/L (mouse), 20–60 μmol/L (rat). - Urine creatinine: used to normalize analyte excretion (e.g., urinary albumin/creatinine ratio).

2.8 BUN (Blood Urea Nitrogen) — Urease-Indophenol Method

Urease hydrolyzes urea to ammonia and CO₂. Ammonia reacts with hypochlorite and salicylate to form a green indophenol dye (Berthelot reaction).

Urea + H₂O ──[Urease, 37°C, 15 min]──→ 2 NH₃ + CO₂

NH₃ + Salicylate + NaOCI ──[Nitroprusside catalyst]──→ Indophenol (green-blue, 630 nm)
Parameter Specification
Wavelength 630 nm
Detection limit 0.5 mmol/L
Linear range 1–25 mmol/L urea
Intra-assay CV <4%
Inter-assay CV <8%
Standard 10 mmol/L urea (included)

Reference Ranges:

Species BUN (mmol/L) Creatinine (μmol/L)
Human 2.5–7.5 44–106
Mouse 5–12 15–40
Rat 4–10 20–60
Dog 2.5–9.5 44–130

2.9 Total Protein — Biuret Method

Peptide bonds in proteins form a violet complex with Cu²⁺ in alkaline solution (biuret reaction).

Protein (peptide bonds) + Cu²⁺ ──[NaOH, pH ~12]──→ Cu²⁺-peptide complex (violet, 540 nm)
Parameter Specification
Wavelength 540 nm
Detection limit 0.1 g/L
Linear range 0.5–100 g/L
Intra-assay CV <3%

2.10 Total Bilirubin — Jendrassik-Grof Method

Bilirubin reacts with diazotized sulfanilic acid (diazo reagent) to form azobilirubin (red-purple). Caffeine-sodium benzoate accelerates the reaction by disrupting bilirubin-albumin binding.

Bilirubin + Diazotized sulfanilic acid ──[Caffeine, 30 min]──→ Azobilirubin (540 nm)
Parameter Specification
Wavelength 540 nm
Detection limit 1 μmol/L
Linear range 2–200 μmol/L
Intra-assay CV <5%

3. Optimized Reaction Parameters

3.1 ALT/AST Modified Protocol (High Sensitivity)

Step Standard High Sensitivity (Low Activity)
Sample volume 50 μL 100 μL (reduce calibrator volume)
Substrate volume 100 μL 50 μL (concentrated)
Incubation 30 min 60 min
DNPH incubation 20 min 30 min
NaOH development 0.4 M, 10 min 0.4 M, 15 min

Note: The high-sensitivity modification achieves a detection limit of 0.5 U/L. Validate linearity when modifying incubation times.

3.2 ALP Optimization by Sample Type

Sample Incubation Time Expected Activity Dilution Factor
Human serum (normal) 30 min 40–150 U/L None
Serum (cholestasis) 15 min 200–800 U/L 1:2 with saline
Bone tissue extract 30 min 50–300 U/L None
Intestinal mucosa 30 min 100–500 U/L 1:2
Cell lysate 30–60 min 10–200 U/L Variable

4. Sample Preparation Guide

Assay Sample Prep Storage Notes
ALT/AST Serum, no hemolysis 2–8°C, 48 h; -20°C, 1 month Hemolyzed samples give invalid results (RBC contains AST)
ALP Serum, fresh preferred 2–8°C, 5 days ALP activity decreases on freezing; avoid freeze-thaw
GGT Serum, no special prep 2–8°C, 7 days; -20°C, 1 month Stable; pregnancy can falsely elevate
LDH Serum (separate from cells promptly) 2–8°C, 3 days RBC LDH is ~100× serum; even minimal hemolysis invalidates results
Creatinine Serum or urine 2–8°C, 7 days; -20°C, 3 months Deproteinize before measurement
BUN Serum or plasma 2–8°C, 1 week; -20°C, 1 month Ammonium heparin anticoagulant invalidates assay
Bilirubin Serum, protect from light 2–8°C, 2 days (dark) Protect from light — bilirubin is photolabile

5. Interference Table

Substance ALT (DNPH) AST (DNPH) ALP (pNPP) LDH (NADH) Creatinine (Jaffe) BUN (Indophenol)
Hemoglobin (>0.5 g/L) Strong Strong None Strong Moderate None
Triglycerides (>5 mM) Moderate Moderate None None None None
Bilirubin (>200 μmol/L) Moderate Moderate None None None None
Pyruvate (>1 mM) Strong Strong None None None None
Ascorbic acid (>1 mM) None None None None None Strong
EDTA None None Inhibits (chelates) None None None
Ammonium heparin None None None None None Strong
Glucose (>20 mM) None None None None Moderate None

6. Reference Ranges (Rodent)

Assay Mouse Serum Rat Serum Human Serum
ALT (U/L) 25–80 20–60 7–40
AST (U/L) 50–150 40–120 10–35
ALP (U/L) 40–120 60–200 40–120
GGT (U/L) 0–5 0–5 5–40
LDH (U/L) 200–600 150–500 100–250
Creatinine (μmol/L) 15–40 20–60 44–106
BUN (mmol/L) 5–12 4–10 2.5–7.5

Note: Reference ranges are provided for the C57BL/6 mouse (8–12 weeks, male) and Sprague-Dawley rat. Significant strain, age, and sex differences exist. Always run age- and sex-matched controls.

7. Drug-Induced Liver Injury Markers — Suggested Panel

Injury Pattern Key Markers Typical Findings
Hepatocellular ALT ⬆, AST ⬆, ALT > AST APAP, CCl₄, CCl₃-induced injury
Cholestatic ALP ⬆, GGT ⬆, Bilirubin ⬆ ANIT, α-naphthylisothiocyanate
Mixed ALT ⬆, ALP ⬆, GGT ⬆ Various drugs
Mitochondrial AST > ALT, LDH ⬆ Fialuridine, valproic acid

For full product range, pricing, and ordering: solarbio.store