|Viral load||False viral load||Inconsistency with antibody tests||DNA|
|Multicentre quality control of polymerase chain reaction for detection of HIV DNA.|| ||Defer C, Agut H, Garbarg-Chenon A, Moncany M, Morinet F, Vignon D, Mariotti M, Lefrere JJ
| ||Seven French laboratories tested the specificity and sensitivity of the polymerase chain reaction (PCR) for the detection of HIV-1 DNA. Following its own PCR protocols, each laboratory independently tested blind two panels of 20 coded peripheral blood mononuclear cell samples collected from HIV-1-seropositive individuals and from HIV-1-seronegative individuals at high or low risk of HIV infection. False-positive and false-negative results were observed in all laboratories (concordance with serology ranged from 40 to 100%). In addition, the number of positive PCR results did not differ significantly between high- and low-risk seronegatives. Discrepancies between laboratories indicated that factors other than primer pairs contributed strongly to laboratory variability."|
| ||AIDS 1992 Jul;6(7):659-63||1992|
|Low HIV-1 proviral DNA burden detected by negative polymerase chain reaction in seropositive individuals correlates with slower disease progression|| ||Schechter, M., et al.,
| ||33 ELISA-positive and even Western blot-positive subjects were HIV-negative based on the PCR test for HIV DNA . These subjects were from a group of 316 homosexuals of which 158 (50%) were PCR-positive. The report also cites further studies documenting that 14 to 17% of antibody-positive homosexuals are HIV-provirus free.|
| ||AIDS 5, 373-379, 1991||1991|
|Concordance of polymerase chain reaction with HIV antibody detection.|| ||Horsburgh CR et al.
| ||“HIV DNA was detected by PCR in 58 (92%) of 63 HIV antibody-positive samples...5 persons had PCR-negative samples that were negative with all 3 primer pairs...Subsequent serum samples from four of these men were also HIV antibody-positive; the fifth was lost to follow up...HIV DNA was detected in 7 (3.4%) of 208 samples in which there was no detectable HIV antibody...Despite [extensive] precautions, 2 (3%) of 65 PCR-positive results were false-positives. It is also positive that the positive PCR results before seroconversion were false-positives, since exposure to HIV continued to occur”|
| ||JID. 1990 Aug;162:542-5.||1990|
|Persistently negative HIV-1 antibody enzyme immunoassay screening results for patients with HIV-1 infection and AIDS: serologic, clinical, and virologic results.|| ||Sullivan PS, Schable C.
| ||“This report describes the field and laboratory investigation of eight patients who had clinical evidence of HIV infection, but repeatedly negative HIV-1 antibody screening results in the course of their clinical care. In all patients, HIV infection was proven [sic] by other diagnostic methods [PCR/viral load, p24 antigen and culture techniques]...Patient 6...became acutely ill after vaccination for measles, mumps and rubella...[she had a] negative HIV EIA on 2 occasions, a positive HIV-1 p24 antigen result, and a positive HIV-1 DNA PCR result. Prior HIV EIA results were negative 2 years, 1 year and 2 weeks before hospitalization... Patient 2...HIV EIA result was negative during admission, but HIV infection was identified by HIV p24 antigen testing and DNA PCR...”|
| ||AIDS. 1999 Jan 14;13(1):89-96.||1999|
|Detection of HIV DNA in peripheral blood by the polymerase chain reaction: a study of clinical applicability and performance.|| ||Young KKY et al.
| ||“the specificity and sensitivity of PCR for detection of HIV DNA were 100% (225/225 seronegative, low-risk individuals tested negative) and 94% (67/71 seropositive individuals tested positive), respectively. In a second study ... 7/474 (1.5%) antibody-negative specimens were found to be positive [for HIV DNA], 149/151 (99%) antibody-positive specimens were positive [for DNA], and 12/13 (92%) antibody-indeterminate specimens were negative for HIV DNA”|
| ||AIDS. 1990;4:389-91.||1990|
|Poor sensitivity, specificity, and reproducibility of detection of HIV-1 DNA in serum by polymerase chain reaction (PCR).|| ||Busch MP et al.
| ||In this study, they did PCR-DNA tests on 151 ELISA-negative people and found that 18.5% (28 people) had positive PCRs. Furthurmore, they found that only 25.5% of people diagnosed HIV-positive had positive PCR's. In their conclusion section they draw attention to how close the two numbers, 18.5% and 25.5%, are:"This study of PCR detection of HIV-DNA in serum identified a disturbingly high rate of nonspecific positivity with a widely employed gag primer pair system [gag is a protein considered to be specific to HIV]. In fact, the overall positivity was not significantly different for serum specimens from seropositive patients and seronegative control donors (25.5% vs 18.5%). ... In contrast to the high rate of false positive results observed with gag primers, env DNA [env is another protein thought to be specific to HIV] was not detected by laboratory B in any of the specimens from either seronegative or seropositive individuals. Absence of reactions with both primer pairs from all 59 specimens from seropositive persons meant that no serum sample could be confirmed positive for HIV-DNA, i.e. 0% sensitivity. This finding is in marked contrast to the high sensitivity reported previously by Laboratory B for both gag and env primers." Although HIV-DNA testing is not used for viral load measurements, it is of interest to note the significant problems that developed with this test even though the laboratories that produced it claimed that it was highly accuracte, sensitive, and specific.|
| ||Journal of Acquired Immune Deficiency Syndrome . 1992;5(9):872-879.||1992|
|Identification of HIV-infected seronegative individuals by a direct diagnostic based on hybridization to amplified viral DNA.|| ||Loche M, Mach B.
| ||“we analyzed samples from individuals konwn to be at especially high risk of HIV infection-seronegative sexual partners of seropositive individuals...Of 16 seronegative partners tested, 5 were unequivocally positive for HIV DNA. The clinical records of these 5 subjects confirmed that they were seronegative by enzyme-linked immunsorbent assay and western blot and negative for the p24 antigen at the time the blood samples were taken for the DNA assay...the same 5 samples were found to be positive with a second HIV-specific oligonucleotide...The serological [antibody] status was confirmed in each case and each of the 5 individuals was negative for anti-HIV antibodies and p24 antigen 2 and 3 months after the initial detection of HIV DNA”|
| ||Lancet. 1988;ii:418-21.||1988|
|Diagnosis of infection with human immunodeficiency virus type 1 by a DNA polymerase chain reaction assay among infants enrolled in the women and infant's transmission study.|| ||Bremer JM et al.
| ||For 859 specimens from uninfected infants [based on two negative co-cultures], 97% had PCR negativity, 2% had PCR positivity and 1% had indeterminate status. For 223 specimens from HIV-infected infants [based on two positive co-cultures], 89% had PCR positivity, 11% had PCR negativity and <1% had indeterminate status|
| ||J Pediatr. 1996 Aug;129(2):198-207.||1996|