Trade name: Cobas TaqScreen MPX Test, version 2.0 for use with the cobas s 201 system.
Biological name: HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT)
The Cobas MPX Test 2.0 is manufactured by Roche Molecular Systems, Inc.
I was particularly interested in this product because of the disease caused due to the virus HIV. It is one of the most serious health and development challenges. There are about 3.5 million patients who receive blood each year. HIV and Hepatitis are the most common viruses found in donated blood. This blood is donated unchecked can cause various fatal diseases. As Roche Molecular Systems claims, the cobas TaqScreen MPX test is “one test, three results”, it distinguishes between …show more content…
General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
Clinical studies:
Reproducibility: This study showed that the cobas MPX test shows highly reproducible results across sites, lots and days at different concentrations.
Clinical specificity:
Whole blood donor: A total of 13,306 whole blood donations were tested and the clinical specificity foe individual testing was found to be 99.895%. Similarly, in pool testing the results were found to 99.866% from 10,500 pools tested.
Specificity in Source Plasma Donor Samples:
Plasma pool testing: The clinical specificity for 96 individual specimens was found to be 98.04%.
Studies in High risk population:
High risk individuals included, but were not limited to, drug abuse via injection, multiple sex partners, unprotected sex, blood transfusion history, history of STD’s, tattoos or body piercings. A total of 570 specimens were collected at four different sites.
The results presented that in neat samples the Cobas MPX v2 detected 99 out of 567 samples and in diluted (1:6) it detected 80 out of 570 samples, which was considered a great improvement compared to Roche’s cobas MPX
Biological name: HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT)
The Cobas MPX Test 2.0 is manufactured by Roche Molecular Systems, Inc.
I was particularly interested in this product because of the disease caused due to the virus HIV. It is one of the most serious health and development challenges. There are about 3.5 million patients who receive blood each year. HIV and Hepatitis are the most common viruses found in donated blood. This blood is donated unchecked can cause various fatal diseases. As Roche Molecular Systems claims, the cobas TaqScreen MPX test is “one test, three results”, it distinguishes between …show more content…
General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
Clinical studies:
Reproducibility: This study showed that the cobas MPX test shows highly reproducible results across sites, lots and days at different concentrations.
Clinical specificity:
Whole blood donor: A total of 13,306 whole blood donations were tested and the clinical specificity foe individual testing was found to be 99.895%. Similarly, in pool testing the results were found to 99.866% from 10,500 pools tested.
Specificity in Source Plasma Donor Samples:
Plasma pool testing: The clinical specificity for 96 individual specimens was found to be 98.04%.
Studies in High risk population:
High risk individuals included, but were not limited to, drug abuse via injection, multiple sex partners, unprotected sex, blood transfusion history, history of STD’s, tattoos or body piercings. A total of 570 specimens were collected at four different sites.
The results presented that in neat samples the Cobas MPX v2 detected 99 out of 567 samples and in diluted (1:6) it detected 80 out of 570 samples, which was considered a great improvement compared to Roche’s cobas MPX