K Logo Kamiya Biomedical Company
K-ASSAY
Since 1983
K-Assay
 
Clinical Diagnostics
Immunoassay Reagents
 
Lp(a) / Lipoprotein (a)
Cat. No.: KAI-044   or   KAI-017
Type.: Reagent
Method: Immunoturbidimetric
Format: Liquid
Linearity: 5 - 150 mg/dL
Sample: Serum


KIT COMPOSITION
Cat. No. KAI-044
R1:   1 X 21 mL buffer
R2:   1 X 3 mL antibody

Tests / Kit:   60 (Hitachi 717)
(Can Vary Based On Analyzer Model)
    
KAI-044
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheets (SDS):
Reagent-1 (R-1)
Reagent-2 (R-2)

Click here for information about recommended calibrators and controls.




Cat. No. KAI-017
R1:   3 X 21 mL buffer
R2:   3 X 3 mL antibody

Tests / Kit:   180 (Hitachi 717)
(Can Vary Based On Analyzer Model)

    
KAI-017
Click Image To Enlarge       

Click here for an example package insert.

Click here for the Safety Data Sheets (SDS):
Reagent-1 (R-1)
Reagent-2 (R-2)

Click here for information about recommended calibrators and controls.


INTENDED USE
For the quantitative determination of human lipoprotein(a) [Lp(a)] in human serum by immunoturbidimetric assay.  The test may provide in conjunction with other lipoprotein tests, the risk assessment of coronary artery disease for specific populations.
FOR IN VITRO DIAGNOSTIC USE.

REAGENT PREPARATION
The reagents are ready to use and do not require reconstitution.

STORAGE AND HANDLING
All reagents should be stored refrigerated (2-8°C).  Return all reagents to 2-8°C promptly after use.  Unopened reagents can be used for one year from the date of manufacture, as indicated by the expiration date on the package and bottle labels.  Opened reagents can be used for one month if stored at 2-8°C.

PERFORMANCE
Precision

Precision - Within Run
Sample I Sample II Sample III
N = 20 N = 20 N = 20
Mean = 10.5 Mean = 22.9 Mean = 44.9
S.D. = 0.317 S.D. = 0.490 S.D. = 0.587
C.V. = 3.02% C.V. = 2.14% C.V. = 1.31%

Precision - Between Runs
Sample I Sample II Sample III
N = 10 N = 10 N = 10
Mean = 9.7 Mean = 18.6 Mean = 45.1
S.D. = 0.35 S.D. = 0.40 S.D. = 0.81
C.V. = 3.65% C.V. = 2.15% C.V. = 1.80%

Accuracy / Correlation
A comparison of the K-ASSAY ®   Lp(a) and another company's Lp(a) ITA was performed with the following results:

y = 1.0084x + 1.1518
r = 0.9967
n = 85
x = another company's Lp(a) assay
y = K-ASSAY ®   Lp(a) assay

x min = 3.00 y min = 4.60
  max = 93.80   max = 97.00
  mean = 18.64   mean = 19.94

Assay Range
5 - 150 mg/dL

INTERFERENCE
Bilirubin F and C :     No interference up to 25 mg/dL
Hemoglobin :     No interference up to 500 mg/dL
Lipemia :     No interference up to 10%
Plasminogen :     No interference up to 150 mg/dL