ALT-1 POC Test

2017-02-27 VIEW:

Alanine Aminotransferase (ALT) is widely used for detection and management of liver disease. Current ALT tests rely on laboratory instruments to measure enzymatic ALT, limiting their availability especially for patients in resource-poor and remote settings who represent the majority of the global burden of acute hepatitis(including HAV and HEV) and chronic hepatitis (including HBV and HCV), alcohol or drug related liver injury as well as metabolic liver diseases. 
BioPoint® has developed a rapid, point of care test BioPoint® ALT-1 that provides a visual, semi-quantitative measure of ALT in plasma or whole blood from finger prick or venous blood collection, detecting the liver-specific ALT1 protein directly, rather than enzymatic ALT activity which is derived from both ALT1 and ALT2. The test results correlate well with the laboratory results from hospitals. It provides a convenient device for testing liver damage in the clinics and community settings in developing and developed countries
Results are interpreted visually by comparing                      The Axxin AX-2X instrument is a small, portable
the colour intensity of the Test (T) line with                          battery-operated reader that is designed to 
the Reference Line(equivalent to ALT 40 U/L)                       facilitate quantitative readout and integration with
                                                   laboratory information systems
Test Performance :
1. A total of 106 clinical blood specimen were collected from Jiangsu Province Hospital, Nanjing, China
2. Whole blood and plasma samples were tested by POCT BioPoint®ALT-1 Test
3. Results were compared with ALT levels tested by the hospital laboratory
* Correlation between Clinical ALT Levels and BioPoint® ALT-1 Results in Plasma Samples
                                              Visual Reading(Semi-quantitative)      
              sensitivity(≥40 U/L): 93.9%  Specificity(<40U/L): 84.9%   Overall accuracy: 87.7%
                                            Quantitative Data by Axxin AX-2X Reade
* Correlation between Whole Blood and Plasma
Intellectual Property:
Patent application PCT/IB2017/055943, “Point of care assays”.