MQAP Glossary of Terms

MQAP Data Dictionary

Term Description
% viability Measurement of a proportion of viable cells vs. nonviable cells living after treatment.
ACV Acyclovir
ART antiretroviral therapy
Assay endpoint The point at which a final measurement is taken.
Assay readout Numerical expression of an assay or instrument measurement which includes units of measurement (such as ug/mL, % viability, % control, etc.).
ATI Analytic Treatment Interruption
AVEG AIDS Vaccine Evaluation Group
Bacterial / Protozoa Assay An assay which measures the ability of a microbicide to inhibit infection of various cells or tissues by bacterial or protozoan organisms. This includes aerobes and anaerobes that cause bacterial vaginosis, chlamydia, trichomonas, and streptococcus.
Biomarker The physical, biological, or chemical functional indicator(s) of a physiological or disease process that has a diagnostic and/or prognostic utility.
BSL Biosafety Level
Caco-2 Colorectal adenocarcinoma cells
CAIA Cell-associated infection assay
CC50 Cytotoxicity concentration: concentration of an agent at which 50% of the target cells are nonviable.
CCR5 A primary viral surface co-receptor that enables HIV to infect T-cells in early infection. Although this is the primary co-receptor, CXCR4 can also become a primary co-receptor in later infection.
CD4 Dependent Transmission Inhibition assay The CD4 transmission inhibition assay measures the ability of a microbicide to prevent cell-to-cell viral transmission. The CD4 cell line expresses HIV-1 co-receptors, X4, R5, or both X4/R5.
CD4 Independent Transmission Inhibition assay A target assay which measures the ability of a microbicide to prevent cell-to-cell viral transmission. The ME180 cell line is the target. ELISA measurements of p24 are generally the efficacy endpoint. This assay can also measure cytotoxicity.
Cell control An untreated sample that serves as background or baseline measurement.
CFIA Cell-free infection assay
Chemokine Any of various cytokines produced in acute and chronic inflammation that mobilize and activate white blood cells.
CMV cytomegalovirus
CPE Cytopathic effect
CTL cytotoxic T lymphocytes
CXCR4 A primary viral surface co-receptor that enables HIV to infect T-cells in later infection. Although this is a primary co-receptor, CCR5 is usually the primary in early infection.
Cytoxicity A toxic effect of a compound on cells or tissue.
Data Numerical values resulting from an experimental assay.
Data analyzed Data which has been manipulated, organized, or summarized.
DC dendritic cell
Dendritic cell assay An assay which measures the level of viral infectivity in dendritic cells in the presence of microbicide.
Differential The mathematical difference between the values obtained for a virus control and a cell control in an assay. (Virus control minus cell control = differential; MQAP)
DS Dextran sulfate
EBV Epstein-Barr virus
EC50 50% Effective Concentration. The EC50 represents the drug plasma concentration/AUC required for obtaining 50% of the maximum effect in vivo. Also used to express 50% viral inhibition in vitro.
Efficacy The ability of a microbicide to inhibit replication of a microbial pathogen. A measure of a drug's effectiveness.
F ratio Variability in experimental measurements between replicates divided by the variability in experimental measures within replicates.
FCS Fetal Calf Serum.
GCP Good clinical practices
GCRC General Clinical Research Center
GI gastrointestinal
GLP Good laboratory practices
GMP Good manufacturing practices
GRAS generally regarded as safe
HAART Highly active antiretroviral therapy
HBV Hepatitis B virus
HCLB HeLa CD4 cells transformed with the bacterial lacZ gene under the control of the HIV-1 LTR engineered to stably express CD4 only.
HCV Hepatitis C virus
HEC1A Endometrial adenocarcinoma cells
HeLa cells (unmodified) Human cervical carcinoma cell line (immortal)
Hepatitis Assay An assay which measures the ability of a microbicide to inhibit infection of various cells or tissues by hepatitis A or hepatitis B.
Herpes Assay An assay which measures the ability of a microbicide to inhibit infection of various cells or tissues by HSV-1 or HSV-2.
HOS-CD4-X4/R5 Human osteosarcoma cells engineered to stably express CD4, CCR5,and CXCR4.
HPV Human papillomavirus
HSV-1 Herpes simplex virus Type 1
HSV-2 Herpes simplex virus Type 2
Human AB male Human serum type AB (male donor)
HVK Human vaginal keratinocytes
IC50 Inhibitory Concentration 50. The IC50 represents the concentration of a drug that is required for 50% inhibition of viral replication in vitro.
interleukin Any class of lymphokines that act to stimulate, regulate, or modulate lymphocytes such as T cells.
Interleukin-1 (IL-1) Produced by activated macrophages, endothelia cells, B-cells, and fibroblast cells. It induces inflammatory responses, edema, promotes the production of prostagladins, IL-2, and the growth of leukocytes. IL-1beta is being studied in the Microbicide Quality Assurance Program (MQAP) as a potential surrogate marker for vaginal mucosal inflammation.
Interleukin-6 (IL-6) Stimulates several types of leukocytes and the production of acute phase proteins in the liver. It is particularly important in inducing B-cells to differentiate into antibody forming cells (plasma cells).
Interleukin-8 (IL-8) Produced by most cells of the body, especially macrophages and endothelia cells. It enhances inflammation by enabling immune cells to migrate into tissue, and is a powerful inducer of chemotaxis for neutrophil cells.
IUPM Infectious units per million
IVR intravaginal ring
MDM Monocyte-derived macrophages
ME180 Human carcinoma cervical epithelial cell line
MEC minimum effective concentration
Media control Cell culture condition containing media alone; serves as a negative control for an experiment.
MHC major histocompatability complex
MIC50 Minimal inhibitory concentration; the concentration of a compound that inhibits 50% of microbial growth.
microbicide Topical agents applied vaginally or rectally for protection against HIV or other STDs.
MOI Multiplicity of infection
Monocyte / macrophage assay An assay which measures the level of viral infectivity in macrophages in the presence of microbicide
MSD Meso Scale Discovery System
MT-2 Human T-cell leukemia cell line
NERT Natural endogenous reverse transcription
NHP non-human primate
OD Optical density; Absorbance readings may be at various wavelengths, depending on the type of experiment and reference values.
OI opportunistic infection
P4-CCR5 HeLa CD4 cells transformed with the bacterial lacZ gene under the control of the HIV-1 LTR engineered to stably express CD4 and CCR5.
PBMC assay An assay which measures the level of viral infectivity in PBMC lines in the presence of microbicide. PBMCs are also used in co-culture assays for detecting cell-to-cell transmission. Viruses tested include HIV-1, HIV-2, SHIV, and SIV.
PBS Phosphate buffered saline
percent recovery An assay data result which is calculated by the measured concentration divided by the known spike concentration, multiplied by *100.
PFU Plaque forming units
Phase I Clinical Trial A safety study that is between 1-6 months in duration and has an enrollment of 25-40 participants. (Global Campaign News; March 2007)
Phase II Clinical Trial A safety /efficacy study that is up to 2 years in duration with an enrollment of 200-400 participants. (Global Campaign News; March 2007)
Phase III Clinical Trial An efficacy study that is 2-4 years in duration with an enrollment of 3,000-10,000 participants. (Global Campaign News; March 2007)
PMN elastase Biochemical marker for granulocyte stimulation.
prevalence A measure of the number of total cases of a disease in a population at a defined moment in time. For example, the prevalence of pre-existing HIV infection, as determined at screening for clinical trial participation.
Raw data Data that are generated directly from a plate reader or other instrument. Also may include data from lab notes.
Reagent blank The media in which an assay calibration curve is solubilized.
SHIV chimeric simian/human immunodeficiency virus
SI The selective index is also known as a therapeutic ratio or margin of safety. It is a comparison of the amount of drug that causes a therapeutic effect to the amount that causes a toxic effect. SI is calculated by dividing TC50/IC50 or TC50/EC50.
SIA sperm-immobilizing activity
SIV simian immunodeficiency virus
SLPI Secretory Leukocyte Protease Inhibitor, a soluble innate factor.
spermicidal The ability of a compound to inhibit motility, velocity and/or other biochemical characteristics of spermatozoa as proven by documented laboratory evaluation using an in vitro sperm kinetics or sperm binding assay (i.e. Sander-Cramer, CASA, SIA, or other proven methodology). An agent that is destructive to spermatozoa, especially as a contraceptive. Also called spermatocide.
STI Structured treatment interruption
Sup-T1 T-lymphoblast cell line
SW837 Rectal adenocarcinoma cells
TC50 Toxicity concentration: Toxic concentration of an agent at which 50% of the target cells are nonviable.
TCID50 50% tissue culture infection dose. The TCID50 is the quantity of replication-component infectious viral particles.
TI Therapeutic index; calculated by dividing TC50/IC50 or TC50/EC50. TI is also known as the selectivity index, therapeutic ratio, or margin of safety. It is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxic effects. Quantitatively, it is the ratio given by the dose required to produce the toxic effect divided by the therapeutic dose.
Titer quantitative measure of infectious virus
Toxicity Quantitative or qualitative determination of a cytopathic effect of a compound.
U-937 Monocytic cell line
VEC Vaginal-ectocervical tissue
VERO Cell line derived from African Green monkey
VFS 4.5 Vaginal fluid simulant at pH 4.5. An MQAP biological matrix.
VFS 7.2 Vaginal fluid simulant at pH 7.2. An MQAP biological matrix.
Virus control The virus control serves an an in vitro positive growth control culture of cells or tissue and virus.
Zinc Finger Inhibitor A class of experimental anti-HIV drugs which prevents the nucleocapsid part of the HIV Gag protein from capturing and packaging new HIV genetic material into newly budding virions.

Term	Description
% viability	Measurement of a proportion of viable cells vs. nonviable cells living after treatment.
ACV	Acyclovir
ART	antiretroviral therapy
Assay endpoint	The point at which a final measurement is taken.
Assay readout	Numerical expression of an assay or instrument measurement which includes units of measurement (such as ug/mL, % viability, % control, etc.).
ATI	Analytic Treatment Interruption
AVEG	AIDS Vaccine Evaluation Group
Bacterial / Protozoa Assay	An assay which measures the ability of a microbicide to inhibit infection of various cells or tissues by bacterial or protozoan organisms. This includes aerobes and anaerobes that cause bacterial vaginosis, chlamydia, trichomonas, and streptococcus.
Biomarker	The physical, biological, or chemical functional indicator(s) of a physiological or disease process that has a diagnostic and/or prognostic utility.
BSL	Biosafety Level
Caco-2	Colorectal adenocarcinoma cells
CAIA	Cell-associated infection assay
CC50	Cytotoxicity concentration: concentration of an agent at which 50% of the target cells are nonviable.
CCR5	A primary viral surface co-receptor that enables HIV to infect T-cells in early infection. Although this is the primary co-receptor, CXCR4 can also become a primary co-receptor in later infection.
CD4 Dependent Transmission Inhibition assay	The CD4 transmission inhibition assay measures the ability of a microbicide to prevent cell-to-cell viral transmission. The CD4 cell line expresses HIV-1 co-receptors, X4, R5, or both X4/R5.
CD4 Independent Transmission Inhibition assay	A target assay which measures the ability of a microbicide to prevent cell-to-cell viral transmission. The ME180 cell line is the target. ELISA measurements of p24 are generally the efficacy endpoint. This assay can also measure cytotoxicity.
Cell control	An untreated sample that serves as background or baseline measurement.
CFIA	Cell-free infection assay
Chemokine	Any of various cytokines produced in acute and chronic inflammation that mobilize and activate white blood cells.
CMV	cytomegalovirus
CPE	Cytopathic effect
CTL	cytotoxic T lymphocytes
CXCR4	A primary viral surface co-receptor that enables HIV to infect T-cells in later infection. Although this is a primary co-receptor, CCR5 is usually the primary in early infection.
Cytoxicity	A toxic effect of a compound on cells or tissue.
Data	Numerical values resulting from an experimental assay.
Data analyzed	Data which has been manipulated, organized, or summarized.
DC	dendritic cell
Dendritic cell assay	An assay which measures the level of viral infectivity in dendritic cells in the presence of microbicide.
Differential	The mathematical difference between the values obtained for a virus control and a cell control in an assay. (Virus control minus cell control = differential; MQAP)
DS	Dextran sulfate
EBV	Epstein-Barr virus
EC50	50% Effective Concentration. The EC50 represents the drug plasma concentration/AUC required for obtaining 50% of the maximum effect in vivo. Also used to express 50% viral inhibition in vitro.
Efficacy	The ability of a microbicide to inhibit replication of a microbial pathogen. A measure of a drug's effectiveness.
F ratio	Variability in experimental measurements between replicates divided by the variability in experimental measures within replicates.
FCS	Fetal Calf Serum.
GCP	Good clinical practices
GCRC	General Clinical Research Center
GI	gastrointestinal
GLP	Good laboratory practices
GMP	Good manufacturing practices
GRAS	generally regarded as safe
HAART	Highly active antiretroviral therapy
HBV	Hepatitis B virus
HCLB	HeLa CD4 cells transformed with the bacterial lacZ gene under the control of the HIV-1 LTR engineered to stably express CD4 only.
HCV	Hepatitis C virus
HEC1A	Endometrial adenocarcinoma cells
HeLa cells (unmodified)	Human cervical carcinoma cell line (immortal)
Hepatitis Assay	An assay which measures the ability of a microbicide to inhibit infection of various cells or tissues by hepatitis A or hepatitis B.
Herpes Assay	An assay which measures the ability of a microbicide to inhibit infection of various cells or tissues by HSV-1 or HSV-2.
HOS-CD4-X4/R5	Human osteosarcoma cells engineered to stably express CD4, CCR5,and CXCR4.
HPV	Human papillomavirus
HSV-1	Herpes simplex virus Type 1
HSV-2	Herpes simplex virus Type 2
Human AB male	Human serum type AB (male donor)
HVK	Human vaginal keratinocytes
IC50	Inhibitory Concentration 50. The IC50 represents the concentration of a drug that is required for 50% inhibition of viral replication in vitro.
interleukin	Any class of lymphokines that act to stimulate, regulate, or modulate lymphocytes such as T cells.
Interleukin-1 (IL-1)	Produced by activated macrophages, endothelia cells, B-cells, and fibroblast cells. It induces inflammatory responses, edema, promotes the production of prostagladins, IL-2, and the growth of leukocytes. IL-1beta is being studied in the Microbicide Quality Assurance Program (MQAP) as a potential surrogate marker for vaginal mucosal inflammation.
Interleukin-6 (IL-6)	Stimulates several types of leukocytes and the production of acute phase proteins in the liver. It is particularly important in inducing B-cells to differentiate into antibody forming cells (plasma cells).
Interleukin-8 (IL-8)	Produced by most cells of the body, especially macrophages and endothelia cells. It enhances inflammation by enabling immune cells to migrate into tissue, and is a powerful inducer of chemotaxis for neutrophil cells.
IUPM	Infectious units per million
IVR	intravaginal ring
MDM	Monocyte-derived macrophages
ME180	Human carcinoma cervical epithelial cell line
MEC	minimum effective concentration
Media control	Cell culture condition containing media alone; serves as a negative control for an experiment.
MHC	major histocompatability complex
MIC50	Minimal inhibitory concentration; the concentration of a compound that inhibits 50% of microbial growth.
microbicide	Topical agents applied vaginally or rectally for protection against HIV or other STDs.
MOI	Multiplicity of infection
Monocyte / macrophage assay	An assay which measures the level of viral infectivity in macrophages in the presence of microbicide
MSD	Meso Scale Discovery System
MT-2	Human T-cell leukemia cell line
NERT	Natural endogenous reverse transcription
NHP	non-human primate
OD	Optical density; Absorbance readings may be at various wavelengths, depending on the type of experiment and reference values.
OI	opportunistic infection
P4-CCR5	HeLa CD4 cells transformed with the bacterial lacZ gene under the control of the HIV-1 LTR engineered to stably express CD4 and CCR5.
PBMC assay	An assay which measures the level of viral infectivity in PBMC lines in the presence of microbicide. PBMCs are also used in co-culture assays for detecting cell-to-cell transmission. Viruses tested include HIV-1, HIV-2, SHIV, and SIV.
PBS	Phosphate buffered saline
percent recovery	An assay data result which is calculated by the measured concentration divided by the known spike concentration, multiplied by *100.
PFU	Plaque forming units
Phase I Clinical Trial	A safety study that is between 1-6 months in duration and has an enrollment of 25-40 participants. (Global Campaign News; March 2007)
Phase II Clinical Trial	A safety /efficacy study that is up to 2 years in duration with an enrollment of 200-400 participants. (Global Campaign News; March 2007)
Phase III Clinical Trial	An efficacy study that is 2-4 years in duration with an enrollment of 3,000-10,000 participants. (Global Campaign News; March 2007)
PMN elastase	Biochemical marker for granulocyte stimulation.
prevalence	A measure of the number of total cases of a disease in a population at a defined moment in time. For example, the prevalence of pre-existing HIV infection, as determined at screening for clinical trial participation.
Raw data	Data that are generated directly from a plate reader or other instrument. Also may include data from lab notes.
Reagent blank	The media in which an assay calibration curve is solubilized.
SHIV	chimeric simian/human immunodeficiency virus
SI	The selective index is also known as a therapeutic ratio or margin of safety. It is a comparison of the amount of drug that causes a therapeutic effect to the amount that causes a toxic effect. SI is calculated by dividing TC50/IC50 or TC50/EC50.
SIA	sperm-immobilizing activity
SIV	simian immunodeficiency virus
SLPI	Secretory Leukocyte Protease Inhibitor, a soluble innate factor.
spermicidal	The ability of a compound to inhibit motility, velocity and/or other biochemical characteristics of spermatozoa as proven by documented laboratory evaluation using an in vitro sperm kinetics or sperm binding assay (i.e. Sander-Cramer, CASA, SIA, or other proven methodology). An agent that is destructive to spermatozoa, especially as a contraceptive. Also called spermatocide.
STI	Structured treatment interruption
Sup-T1	T-lymphoblast cell line
SW837	Rectal adenocarcinoma cells
TC50	Toxicity concentration: Toxic concentration of an agent at which 50% of the target cells are nonviable.
TCID50	50% tissue culture infection dose. The TCID50 is the quantity of replication-component infectious viral particles.
TI	Therapeutic index; calculated by dividing TC50/IC50 or TC50/EC50. TI is also known as the selectivity index, therapeutic ratio, or margin of safety. It is a comparison of the amount of a therapeutic agent that causes the therapeutic effect to the amount that causes toxic effects. Quantitatively, it is the ratio given by the dose required to produce the toxic effect divided by the therapeutic dose.
Titer	quantitative measure of infectious virus
Toxicity	Quantitative or qualitative determination of a cytopathic effect of a compound.
U-937	Monocytic cell line
VEC	Vaginal-ectocervical tissue
VERO	Cell line derived from African Green monkey
VFS 4.5	Vaginal fluid simulant at pH 4.5. An MQAP biological matrix.
VFS 7.2	Vaginal fluid simulant at pH 7.2. An MQAP biological matrix.
Virus control	The virus control serves an an in vitro positive growth control culture of cells or tissue and virus.
Zinc Finger Inhibitor	A class of experimental anti-HIV drugs which prevents the nucleocapsid part of the HIV Gag protein from capturing and packaging new HIV genetic material into newly budding virions.