HCV IgG ELISA Kit is an enzyme-linked immunosorbent assay (ELISA) for the qualitative determination of antibody to Hepatitis C Virus in human serum or plasma.
COMPONENTS
| No. | Components | Volume | Quantity |
| 1 | Microplate | 8 x 12 well | 1 plate |
| 2 | Positive Control | 0.5 ml | 1 vial |
| 3 | Negative Control | 0.5 ml | 1 vial |
| 4 | Conjugate | 6 ml | 1 vial |
| 5 | Sample Diluent | 11 ml | 1 vial |
| 6 | Wash Buffer (25x) | 30ml | 1 vial |
| 7 | Substrate Solution A | 6 ml | 1 vial |
| 8 | Substrate Solution B | 6 ml | 1 vial |
| 9 | Stop Solution | 6 ml | 1 bottle |
| 10 | Plate Covers | piece | 2 pcs |
| 11 | Instruction | piece | 1 pc |
ANALYTICAL PERFORMANCE CHARACTERISTICS
1. Sensitivity
The sensitivity studies have been made on a panel of 738 positive samples. DAAN HCV has presented a 99.8% sensitivity on true HCV positive panels.
2. Specificity
The specificity has been determinated on blood donors samples (2318 samples tested) and on hospitalized patients (348 samples tested). The specificity calculated is 98.9% and 98.5% respectively.
3. Precision
Assay 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.
Table I: Table shows reproducibility of assay results performed on DAAN HCV.
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.
DAAN Gene is a high-tech enterprise oriented in molecular diagnostic techniques. With the Certificate of GMP, DAAN Gene is consistently committed to R&D, production and service of in-vitro diagnostic products, including ELISA and Rapid Test diagnostic kits, PCR, TRF and related equipment.
The headquarters of DAAN Gene is located in Guangzhou Science Park, Guangzhou, China. It consists of an office building, a scientific research building, and first class 10,000 and 100,000 sq.m.clean manufacturing workshops. It also hosts the base for the National High-tech Industrialization Demonstration Project, which covers an area of 27,156 sq.m. with a 16,150 sq.m. construction area. The base is equipped with various advanced scientific research instruments and production facilities. It has reached the level of the leading biotech enterprises, acquiring an annual reagent production capacity of 20 million tests.
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.
With 20 years in development, DAAN Gene has an efficient technology and management team of over 800 staff, including more than 300 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, America and some Southeast Asian countries.
We have full product line of rapid test, Elisa,TRF, food safety and PCR. We are ISO 9001, ISO 13485 certificated. Some of our products like LH, HCG, FSH, FOB, DOA and PSA are CE marked.