USE OF PCR FOR DIAGNOSING HIV-1 INFECTION IN PEDIATRIC PATIENTS

Award Information
Agency:
Department of Health and Human Services
Amount:
$381,682.00
Program:
SBIR
Contract:
N/A
Solitcitation Year:
N/A
Solicitation Number:
N/A
Branch:
N/A
Award Year:
1992
Phase:
Phase II
Agency Tracking Number:
13607
Solicitation Topic Code:
N/A
Small Business Information
Biotech Research Laboratory
1600 E Gude Dr, Rockville, MD, 20850
Hubzone Owned:
N
Woman Owned:
N
Socially and Economically Disadvantaged:
N
Duns:
N/A
Principal Investigator
 Mark M Manak
 (301) 251-0800
Business Contact
Phone: () -
Research Institution
N/A
Abstract
PREVALENCE STUDIES FOR HIV-1 INFECTION IN NEWBORNS ARE DIFFICULT TO OBTAIN BECAUSE THE COMMONLY USED ANTIBODY ASSAYS ARE NOT APPROPRIATE FOR TESTING BABIES. BABIES CARRYTHE MATERNAL ANTIBODY FOR UP TO 12 TO 18 MONTHS AFTER BIRTH,SO ALL BABIES BORN TO SEROPOSITIVE MOTHERS WILL ALSO TEST POSITIVE. YET 40 TO 50 PERCENT OF THESE BABIES ARE NOT ACTUALLY INFECTED. IN THIS RESEARCH, POLYMERASE CHAIN REACTION (PCR) ASSAYS WILL BE USED TO EXAMINE THE LYMPHOCYTES OF BABIES BORN TO HIV-1 SEROPOSITIVE MOTHERS FOR THE PRESENCE OF THE HIV-1 GENOME. THIS IS AN EXTREMELY SENSITIVE DIRECT TEST FOR THE VIRUS; IT IS CAPABLE OF DETECTING EVEN 10 VIRAL GENOMES IN LESS THAN 1 ML OF BLOOD. PERIPHERAL BLOOD LYMPHOCYTES WILL BE COLLECTED FROM ABOUT 80 BABIES BORN TO HIV-1 SEROPOSITIVE MOTHERS. SAMPLES COLLECTED AT BIRTH AND AT 3-MONTH FOLLOWUP INTERVALS WILL BE TESTED BY PCR AND WESTERNBLOT ASSAYS. THE RESULTS OF THE PCR WILL BE CORRELATED WITH THE SUBSEQUENT LOSS OF MATERNAL ANTIBODY AND SEROCONVERSION TO BABY ANTIBODY. THESE RESULTS WILL DETERMINE WHETHER PCR DATA CAN BE USED AS A RELIABLE INDICATOR OF ACTUAL INFECTION AND A PREDICTOR OF SUBSEQUENT SEROCONVERSION. THESE STUDIES WILL PROVIDE EPIDEMIOLOGICAL DATA FOR THE INCIDENCE OF HIV-1 INFECTION IN BABIES BORN TO SEROPOSITIVE MOTHERS AND PROVIDE A BASIS FOR PREDICTIVE TESTS FOR AIDS IN THESE BABIES.

* information listed above is at the time of submission.

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