>>>NephstarTM Nephelometer: Performance
We have conducted repeated tests on NephstarTM before it enters the market and through comparision with international similar products we conclude that NephstarTM specific protein analyser and the related reagents are of high performance and they are equally good as international standard products, as you can see in the following products performance.
1. IgA kit
1) Intra-batch Precision
Three within-batch measurements were performed at two different concentrations, each experiment consisted of five repeated assays at each concentration. The average coefficient of variation (CV) of the fifteen results at each concentration was calculated:
| IgA（g/l） |
CV（%） |
5.2 |
2.55 |
2.1 |
2.97 |
2) Comparision study
A correlation study was performed on 30 normal and clinical serum samples using this kit on a Nephstar and a Behring IgA kit on a Behring Nephelometer Analyser. The study demonstrated a good agreement between the two systems and the following linear regression equation and correlation coefficient was yielded:
Y=0.96X+0.05 (Y= NEPHSTARTM IgA，X=BNA IgA),? г=0.979
2. IgG kit
1) Intra-batch Precision
Three within-batch measurements were performed at two different concentrations, each experiment consisted of five repeated assays at each concentration. The average coefficient of variation (CV) of the fifteen results at each concentration was calculated:
| IgG（g/l） |
CV（%） |
19.9 |
2.76 |
5.9 |
3.12 |
2) Comparision study
A correlation study was performed on 30 normal and clinical serum samples using this kit on a Nephstar and a Behring IgA kit on a Behring Nephelometer Analyser. The study demonstrated a good agreement between the two systems and the following linear regression equation and correlation coefficient was yielded:
Y=0.92X+0.28 (Y= NEPHSTARTM IgG，X=BNA IgG),? г=0.986
3. IgM kit
1) Intra-batch Precision
Three within-batch measurements were performed at two different concentrations, each experiment consisted of five repeated assays at each concentration. The average coefficient of variation (CV) of the fifteen results at each concentration was calculated:
| IgM（g/l） |
CV（%） |
3.35 |
2.68 |
0.48 |
1.89 |
2) Comparision study
A correlation study was performed on 30 normal and clinical serum samples using this kit on a Nephstar and a Behring IgA kit on a Behring Nephelometer Analyser. The study demonstrated a good agreement between the two systems and the following linear regression equation and correlation coefficient was yielded:
Y=1.13X - 0.10 (Y= NEPHSTARTM IgM，X=BNA IgM); г=0.988
4. ASO kit
1) Intra-batch Precision
Three within-batch measurements were performed at two different concentrations, each experiment consisted of five repeated assays at each concentration. The average coefficient of variation (CV) of the fifteen results at each concentration was calculated:
ASO（IU/mL） |
CV（%） |
88 |
2.45 |
587 |
3.16 |
2) Comparision study
A correlation study was performed on 30 normal and clinical serum samples using this kit on a Nephstar and a Behring IgA kit on a Behring Nephelometer Analyser. The study demonstrated a good agreement between the two systems and the correlation coefficient г=0.992
5. CRP kit
1) Intra-batch Precision
Three within-batch measurements were performed at two different concentrations, each experiment consisted of five repeated assays at each concentration. The average coefficient of variation (CV) of the fifteen results at each concentration was calculated:
CRP（mg/L） |
CV（%） |
11 |
2.98 |
74 |
1.58 |
2) Comparision study
A correlation study was performed on 30 normal and clinical serum samples using this kit on a Nephstar and a Behring IgA kit on a Behring Nephelometer Analyser. The study demonstrated a good agreement between the two systems and the correlation coefficient г=0.975
6. RF kit
1) Intra-batch Precision
Three within-batch measurements were performed at two different concentrations, each experiment consisted of five repeated assays at each concentration. The average coefficient of variation (CV) of the fifteen results at each concentration was calculated:
RF（IU/mL） |
CV（%） |
59 |
3.15 |
380 |
2.33 |
2) Comparision study
A correlation study was performed on 30 normal and clinical serum samples using this kit on a Nephstar and a Behring IgA kit on a Behring Nephelometer Analyser. The study demonstrated a good agreement between the two systems and the correlation coefficient г=0.981
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