Glossary Term
A WHO assessment that confirms a diagnostic meets quality, safety, and performance requirements for procurement by UN agencies and many national programs. WHO PQ status is frequently a tender eligibility criterion for public-health deployment in low- and middle-income countries.
Regulatory Definitions
Technology
A cell-separation technique where magnetizable microspheres or beads are first coated with monoclonal antibody, allowed to search and bind to target cells, and are then selectively removed when passed through a magnetic field. Among other applications, the technique is commonly used to remove tumor cells from the marrow of patients who are to undergo autologous bone marrow transplantation.
Diagnostic Methods
Tests
A proprietary chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma on the Abbott Alinity i system. The persistence of immunoglobulin class G (IgG) antibodies may identify people who have been infected in the past, recovered from the illness, and possibly developed immunity.
For professionals
Tests
A proprietary chemiluminescent microparticle immunoassay (CMIA) used for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma on the Abbott ARCHITECT i system. The persistence of immunoglobulin class G (IgG) antibodies may identify people who have been infected in the past, recovered from the illness, and possibly developed immunity.
For professionals
Tests
An AFP tumor marker test is a blood test that measures the level of AFP (alpha-fetoprotein) in a sample of your blood. AFP is a protein that the liver makes when its cells are growing and dividing to make new cells. AFP levels are normally high in a fetus, but after birth, they drop very low. Healthy children and adults who aren’t pregnant have very little AFP in their blood.
For everyone & professionals
Tests
An ammonia levels test measures the amount of ammonia in a sample of your blood. Ammonia is also called NH3. It is a normal waste product in your body. Healthy bacteria in your intestines make ammonia when you digest protein in the foods you eat.
For everyone & professionals
Indicators
A cancer-specific antigen associated with both tumors and the developing fetus. The main use of this antigen is as a tumor marker, especially with respect to intestinal cancers. Production of the antigen ceases shortly before birth, but may reappear in people who develop certain types of cancer.
Glossary Term
A study that compares two groups of people: those with the disease or condition under study (cases) and a very similar group of people who do not have the disease or condition (controls). Researchers study the medical and lifestyle histories of the people in each group to learn what factors may be associated with the disease or condition. For example, one group may have been exposed to a particular substance that the other was not. Also called retrospective study.
Performance Metrics
Tests
Coagulation factors are proteins in your blood. They help form blood clots to stop bleeding when you have an injury. These proteins are also called clotting factors. You have several different types of clotting factors that are all important for making blood clots.
For everyone & professionals
Glossary Term
A research study that compares a particular outcome (such as lung cancer) in groups of individuals who are alike in many ways but differ by a certain characteristic (for example, female nurses who smoke compared with those who do not smoke).
Performance Metrics
Tests
Dengue fever is a viral infection spread to people through bites from infected mosquitoes . A dengue fever test checks a sample of your blood to see if you have the virus.
For everyone & professionals
Glossary Term
A WHO procedure that time-limits the listing of diagnostics (and other health products) for use in public-health emergencies when full prequalification is not yet available.
Regulatory Definitions