UMA CO., LTD.

MEASURE H-FABP
2-19-6 Yokosuka
Matsudo, Chiba, Japan Reagent for Heart-type fatty acid binding protein
Latex Immunoturbidimetric Method

　2 ~ 8 °C IVD In vitro Diagnostics Packages

R1 1  30 mL R2 1  30 mL
　DO NOT freeze  18 months/block from light R1 1  10 mL R2 1  10 mL

1. PURPOSE OF USE human H-FABP antibody (mouse monoclonal antibody)

In vitro determination of Heart-type fatty acid binding sensitized latex in the latex reagent with a specific antigen-
protein (H-FABP) in blood serum or blood plasma. antibody reaction. Since the degree of turbidity is
proportional to the concentration of H-FABP in the sample,
2. GENERAL INSTRUCTION
the H-FABP concentration in the sample can be determine
1. For in vitro diagnostics use only.
by measuring the change in turbidity.
2. Diagnosis should be made in a comprehensive manner,
in accordance with other related test results and clinical 7. STANDARD MEASUREMENT OPERATION
symptoms by the doctor in attendance. Specimen Calibrator Blank
3. For guaranteed results, usage of this product must (S) (Std) (B)
comply with the instruction in this manual. Specimen (L) 80 - -
4. For automatic analyzers, follow the instruction carefully. Calibrator (L) - 80 -

3. MATERIALS REQUIRED BUT NOT INCLUDED Saline (L) - - 80

- Saline 0.9 % and high grade purified water R-1 (L) 1000 1000 1000

- Micropipet and other basic laboratory equipment. Incubate at 37 C in 5 minutes

- Calibrators and Controls (separatedly sold)
4. REAGENT COMPOSITION & PREPARATION
- Reagent R-1: Good buffer (pH 7.4).
- Reagent R-2: Anti-human H-FABP antibody-conjugated
latex solution.
- Calibrators & Controls (separatedly sold): Calibrators
(Level 1 – Level 6) and controls (L, H) are ready for use
wthout dilution.
5. SAMPLE PREPARATION & STORAGE
- Use serum or plasma as specimens.
- Collect samples by normal method and determine while
they are fresh.
- Analyze sample soon after collection. In case, it could
not be analyzed soon, store samples at -20 ℃ in freezer
and analyze within 1 month (avoid freeze and thaw).
- When using frozen samples, thaw them in room
temperature and determine after mixing it well (transparent
solution) before use.
6. MEASUREMENT PRINCIPLE
When a sample is reacted with a Good buffer and a latex
reagent solution, H-FABP in the sample reacts with anti-
R-2 (L) 1000 1000 1000
Mix well; incubate at 37 C for 5 minutes; measure
absorbance at 570 nm
Note: See sample preparation for details of specimen
8. CALCULATION & UNIT CONVERSION
Calculation
- Calculate ∆Abs of specimen & standards vs blank
- Plot a calibration curve H-FABP (ng/mL) = f(∆Abs)
- Calculate H-FABP in specimen using the curve
(doing same procedure for Controls)
Unit conversion
N/A
9. PERFORMANCE & CORRELATION TEST
Performance
- Sensitivity: Absorbance was less than 0.02 at 700 nm
when purified water was used as sample, and change
around 0.01 ~ 0.03/min when standard solution of H-FABP
of 30 ng/mL was used as sample.
- Specificity: The accuracy is within ±10.0%.
- Reproducibility: CV value < 10.0%.

1/2 Revision 01/2017

- Measuring range: 2 ~ 160 ng/mL wash it immediately with plenty of water and consult the
Correlation test doctor if needed.
Company A (same principle) 3. If reagents are spilled, dilute with water and wipe it out. If
Regression equation: Y = 1.0211X – 0.3480 (n = 60) specimen is spilled, spray 80% of alcohol over the
Correlation coefficient: R = 0.994 specimen and wipe it out.
Company B (different principle) Usage
Regression equation: Y = 1.0009X + 0.5076 (n = 52) 1. Store reagents under specified condition. Do not use
Correlation coefficient: R = 0.993 after expiration date.
(Y: Value obtained from using UMA’s reagent) 2. Do not use the container and auxiliaries included in this
- Between Serum and Plasma kit for other purposes.
Regression equation: Y = 1.0129X – 0.1130 (n=52) 3. Do not mix reagents of different lot for use.
Correlation coefficient: R = 0.999 4. Do not add to the reagent being used even if it is the
(Y: Serum; X: Plasma) same lot number.
Reference Materials for Calibration Disposal
- N/A 1. All specimens, as well as all instruments (e.g. test tubes)
that come in contact with the specimens, must be treated
10. EXPECTED VALUES
by the following methods:
- Less than 6.2 ng/mL
・ Sterilize with an autoclave, subjecting them to high
- Reference range should be established at each facility
pressure saturated steam at 121 °C for more than 20
and judgement should base on measurement results in a
minutes. Do not process waste containing sodium
comprehensive manner together with clinical symptoms
hypochlorite solution with an autoclave.
and other measurement results.
・ Immerse at least one hour in sodium hypochlorite
11. INTERFERENCES
solution (active chloride concentration of over 1000 ppm).
No influence of conjugated bilirubin upto 50 mg/dL, free
2. This reagent contains sodium azide. Sodium azide can
bilirubin upto 50 mg/dL, hemolysis (500 mg/dL), lipemia
react with lead pipe and/or steel pipe and can generate
and ascorbic acid (50 mg/dL) against determination were
explosive metal azide. Make sure to use plenty of water at
observed by internal experiments.
disposal. Concentration of sodium azide in R-2 is 0.05%.
12. INFORMATION FOR AUTOANALYZERS
14. OTHER INSTRUCTIONS AND CAUTION
Calculation Method 2-end point (fix)
- Results may differ depending on the sample/reagent
Temperature 37 C ratio. Adjust parameters for different analyzer.
Specimen 8.0 - Prepare the calibration curve on the day of
Volume (μL) R1 100 determination.
R2 100
Main 700
Wavelength (nm)
Sub- -
Point 1 10
Measurement
Point 2 19
(cycle) Point 3 34

Calibration type Spline

Unit ng/mL

13. HANDLING, USAGE & DISPOSAL

Handling
1. Specimen can be potentially positive for infectious
agents including hepatitis B virus and HIV. Wear glove and
goggle when needed.
2. In case reagents got into skin, eye or mouth by mistake,

2/2 Revision 01/2017