HAV ELISA Kit:
1.Certificate:ISO13485/9001, GMP
2.Sensitivity< 2NCU/ml
3.Precision: Intra-assay(CV)<10%,Inter-assay(CV)<10%
HAV IgM ELISA
[For the detection of HAV IgM in human serum or plasma (in vitro)]
INTENDED USE
HAV IgM ELISA is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of HAV IgM in human serum or plasma.
COMPONENTS
| No. | Components | Volume | Quantity |
| 1 | Microplate | piece | 1 pc |
| 2 | Positive Control | 0.5ml | 1 vial |
| 3 | Negative Control | 0.5ml | 1 vial |
| 4 | Conjugate | 6ml | 1 vial |
| 5 | Wash Buffer (25´) | 30ml | 1 vial |
| 6 | Substrate Solution A | 6ml | 1 vial |
| 7 | Substrate Solution B | 6ml | 1 vial |
| 8 | Stop Solution | 6ml | 1 vial |
| 9 | Plate Covers | piece | 2 pcs |
| 10 | Instruction Manua | piece | 1 pc |
ANALYTICAL PERFORMANCE CHARACTERISTICS
1.Sensitivity
The sensitivity studies have been evaluated by using the national panel of HAV IgM prepared by National Institute For the Control of Pharmaceutical and Biological Products (China), the minimal concentration of detection was not above 2NCU/ml.
2.SpecificityThe specificity has been determinated on blood donors’ samples (8036samples tested) and on hospitalized patients (1670 samples tested). The specificity calculated is respectively 99.92% and 99.13%.
3.PrecisionAssay reproducibility was determined by assaying 3 specimens in replicates of 10 on 2 consecutive runs using the same production lot. The Intra-assay and Inter-assay standard deviation (S.D.) and the coefficient of variation (%CV) were calculated (Table I).
The mean signal to cut-off ratio (S/CO) is defined as the Mean Sample Absorbance divided by the calculated Cut-Off value.
DAAN Gene Co., Ltd. of Sun Yat-sen University was established in 1993 and was listed on the Shenzhen Stock Exchange on August 9, 2004.
With 20 years in development, DAAN Gene has an efficient technology and management team of over 800 staff, including more than 100 doctors, graduates and overseas scientists. As of today, DAAN Gene has set up a distribution network covering all of mainland China, and the products sale scale extends to overseas, including India,Germany, America and some Southeast Asia countries.
Taking “Innovative Technology, Quality First, Prime Integrity, and Service Foremost” as the quality guideline, DAAN Gene has successfully acquired the Certificate of ISO13485:2003 Registration on Nov.22, 2006, and subsequently it has obtained GMP and CE-Certificates for several varieties of diagnostic kits. We have full product line of rapid test, Elisa,TRF, food safety and PCR. Some of our products like LH, HCG, FSH, FOB, DOA and PSA are CE marked.
