Table 1.
Specimen 1 | Specimen 2 | Specimen 3 | Specimen 4 | Specimen 5 | Specimen 6 | Specimen 7 | |
---|---|---|---|---|---|---|---|
Real-time PCR (copies/ml) | Undetectable | <500 | 1,401.5 | 15,406 | 621,588 | 7,647,909 | >5E+7 |
LAMP in integrated isothermal device (copies/ml) | 0/3 | 1/3 (1280) | 1/3 (1920) | 3/3 (19,480)a | 3/3 (845,400)a | 3/3 (6,943,632)a | 3/3 (93,423,405)a |
A series of seven serum specimens were obtained from patients at National Taiwan University Hospital (NTUH). The serum HBV viral DNA was extracted by using the QIAamp Viral DNA Mini Kit. In addition, the HBV DNA viral load was determined by real-time PCR. The HBV viral load of these seven samples ranged from an undetectable level to more than 5 × 107 copies/ml for the testing of our device. The frequency of positive results in triplicate test represents by fractional number. This pre-test shows the quantitative results of turbidity measurements when using the integrated isothermal device in the LAMP reagents containing the different amounts of DNA template from the clinical specimens. These results are good indicators for distinguishing the HBV DNA level in serum.
The mean value of triplicate tests.