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4. Scientific &
Research Activities
Division
of AIDS
§
The
division of AIDS has the following units.
§
HIV
serology and quality control (incorporating the National reference centre for
HIV/AIDS).
§
Epidemiology,
training and counselling.
§
Immunology
of HIV infection and AIDS.
§
AIDS
associated diseases and STDs.
HIV SEROLOGY AND QUALITY CONTROL
Diagnostic Services
During
1997, blood samples from individuals of different high risk behaviours were
tested for HIV infection by different screening tests viz. EIA, Dot Immunoassay
& agglutination test, followed by confirmatory WB test.
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No. of samples tested by various tests
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Categories & Sources of Samples
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No. of samples tested
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EIA
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Dot immunoassay assay (Immuno comb)
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Agglutination test (Capillus)
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Confirmatory (Innolia test)
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No. of samples found Positive
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Total tests performed
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Collected by NICD under surveillance centre (after
counselling)
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1411
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1411
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797
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1411
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129
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129
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3748
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Referred from other institutions (for confirmation of
pre tested HIV status)
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826
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826
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700
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826
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696
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696
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3048
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HIV screening of blood products of human origin
(Received through DCI)
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262
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262
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-
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262
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-
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NIL
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524
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HIV screening activities on foreign students.
Foreign
students coming to Delhi and adjacent states viz. UP, Rajasthan, Punjab etc.
for study in different universities of north India were screened for HIV
infection. A total of 642 foreign students have been screened during 1997, with
only 1 case found to be positive for HIV by WB test. The details of such HIV
positive cases for the last nine years is shown in the graph below:
Distribution of HIV positivity among foreign students (Years 1989 to
1997)
African
countries comprising of Ethiopia, Uganda, Somalia, Kenya, Namibia, Tenzania and
Zambia-constituted 89% of HIV positivity and Asian countries constituted 11%.
Male female ratio = 82:18
Age group wise (15-22) yrs 13
(33%) (31-40) Yrs 2
(5%)
Break up (23-30) yrs 22 (56%) 40 yrs > 2 (5%)
Evaluation of diagnostic test kits for HIV
The
various diagnostic kits (indigenous as well as imported) were evaluated with
the help of standard panel of sera maintained in the laboratory.
A total
of 6 (six) different kits have been evaluated in 1997 for their performance
characteristics, viz. sensitivity specificity, predictive value and delta value.
The results were intimated to the Drug Controller of India
Details
of evaluation of HIV test kits (1997)
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Test kit performance characteristics
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Sr. No.
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Manufacturer dt. of expiry
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No. of kits evaluated
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Type of assav
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Sensitivity
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Specificity
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PPV
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NPV
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Approx. time reqd. for test performance
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Indigenous
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1.
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Comb AIDS
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Span Diagnostic Ltd.
Surat (Gujarat) February 1998
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3 (three) kits
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Visual
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100%
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100%
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100%
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100%
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30 minutes for 46 tests
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2.
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MICROLISA-HIV
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J.Mitra & Co. Ltd. Okhla New Delhi Dt. Of Expiry
Nov.’97
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2 kits (two)
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EIA
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100%
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98.8%
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98.7%
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100%
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Three hour for tests
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3.
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HIV-CHEX ELISA
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Xcyton Diagnostic Pvt. Ltd. Bangalore Dt. of Expiry
15.1.98
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3 (three) kits
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EIA
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99.3%
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99%
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99.2%
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99.4%
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Two hours for tests
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Imported
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1.
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Novapath HIV-1/2 EIA
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Bio-Rad Laboratories and United Biomedical Inc. B
Oct.’97
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2 kits (two)
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EIA
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99.5%
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99.3%
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99.3%
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99.2%
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2 hrs. for 96 tests
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2.
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HIV-Logic (rapid) HIV-I & HIV-2
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Pace Diagnosis Inc. Richmond Hill Canada Feb.’98
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5 kits (five)
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Visual
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99.6%
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99.8%
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99.4%
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99.3%
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25 minutes for
tests
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3.
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INSTANT CHEK HIV1+2
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EY Laboratories Inc. by E-y laboratories (H.K.) Ltd.
July 1997
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4 (four) kits
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Visual
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100%
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100%
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100%
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100%
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10 minutes for
tests
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PPV =
Positive Predictive Value
NPV =
Negative Predictive Value
Evaluation of HIV screening test kits for HIV antibodies in saliva
Evaluation
of HIV screening test kits for saliva samples, in comparison to conventional
serology have been undertaken & still being continued. So far 21 saliva
samples have been tested which showed about 95% correlation with conventional
HIV serology.
Participation in quality control programme
National
Serum
samples have been received from various centres (Zonal Blood Testing Centres
& Sero-surveillance centres located in Delhi) for cross checking of results
for HCV & HBsAg, as a part of quality control services.
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Sr. No.
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Name of Blood Banks
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HBsAg
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HCV
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No. of Reactive samples cross checked
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% Giving discordant results
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No. of Reactive Samples cross checked
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% Giving discordant results
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1.
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Blood Bank, Pussa Road, New Delhi
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-
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-
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15
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Nil
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2.
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Sunil Blood Bank & Transfusion Centre. New Delhi
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2
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Nil
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-
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-
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3.
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Bajaj Blood Bank New Delhi
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-
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-
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8
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Nil
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4.
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RML Hospital, New Delhi
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6
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16%
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2
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0
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5.
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IRCS Blood Bank New Delhi
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19
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37%
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-
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-
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6.
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Rajiv Gandhi Cancer Institute, New Delhi
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65
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21.5%
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8
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3%
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7.
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AFTC New Delhi
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11
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44%
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8
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100%
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8.
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G.B. Pant Hospital, New Delhi
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16
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6%
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-
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-
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9.
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E.S.I. Hospital, New Delhi
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7
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42%
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6
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100%
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10.
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National Heart Institute, New Delhi
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6
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83%
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2
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0%
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11.
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L.N.J.P. Hospital, New Delhi
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-
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-
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7
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85%
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12.
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CNC Blood Bank AIIMS New Delhi
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55
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60%
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55
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90%
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*
Discordant results on account of use of different types of test and test kits.
Gold Standard for HBsAg and HCV has not been used. The procedure is being
standardized for HCV presently.
International
AIDS
reference centre of NICD has been participating in WHO proficiency program
since 1990 and still continuing to participate in the same program. In 1997,
three proficiency panels of sera were received & tested. The details are
shown in the table.
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NICD-DELHI
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AUSTRALIA
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Panel
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No. of
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Type
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EIA
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Capilus
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W.B.
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SR
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No.
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Sample
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Neg
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Pos
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Neg
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Pos
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Neg
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Pos
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Neg.
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Pos.
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3
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14
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Serum samples
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7
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7
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8
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6
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8
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6
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8
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6
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4
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10
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DDS
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5
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5
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8
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2
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4
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6
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4
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6
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5
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10
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DDS
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5
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5
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8
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2
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4
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6
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4
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6
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DDS –
Dried Disc Serum (Filter Paper disc) SR – Sample Reactive
100%
Correlation by Confirmatory W. Blot performed at NICF & Australia. There
was only one discrepant result out of 34 samples as was mentioned in the report
received from the organising centre in Australia.
Epidemiology, Training & counselling services
This
division receives the HIV screening reports from various ZBTCs &
surveillance centres.
The bar
diagram projected below shows various sero-reactivity rates by EIA per thousand
samples of donated blood screened in six reporting states.
A
comparison study of Knowledge, Attitude & Practice on HIV/AIDS has been
conducted between two groups of students, one Indian and the other of foreign
countries (300 students from each group) during 1997. Data so obtained is in
the process of compilation and analysis.
Counselling services
The
various categories of persons, having different kinds of risk behaviours, who
voluntarily reported to NICD for HIV infection testing, have been given
pre-test & post-test counselling; preventive counselling was given to
people in close contact with HIV infected persons. A total of 131 such persons
were given counselling during 1997.
Complied
data of the persons given counselling
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Age
Groups of Individuals
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Major
Risk Groups
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Sex
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0-12
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13-20
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21-25
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26-30
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31-35
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35>
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S.P.
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IVDU
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B.T.R.
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P-HIV (+ve)
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SHAI
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CL
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NDRG
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M
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2
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6
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13
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25
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26
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26
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60
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5
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8
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-
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6
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12
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7
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F
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0
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4
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12
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7
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6
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4
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-
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-
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1
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11
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-
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16
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5
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SP =
Sexual Promiscuity IVDU = Intra Venous drug users BTR = Blood Transfusion recipient CL =
Clinical cases
P-HIV
(+ve) = Sexual Partner of HIV positive person SHAI = Suspected Hospital acquired
infection NDRG = No Definite Risk
Group
AIDS related diseases and STD infections
The
AIDS associated diseases and STD laboratory was set up in the last quarter of
1996 and comprises of two units.
Unit – I (STD Laboratory)
§
The
STD laboratory is engaged in the study on prevalence of STDs in population
attending hospital and STD clinics.
§
The
STD laboratory had been carrying out Gonococcal Antibiotic Susceptibility
testing as a participating laboratory of Gonococcal Antibiotic Susceptibility
Programme (GASP, WHO), being co-ordinated by AIIMS, New Delhi.
The
procedure of Gonococcal identification and antibiotic sensitivity tests were
according to Standard Operating Procedure Manual from GASP.
The
summary of the antimicrobial sensitivity pattern of N. gonorrhoea observed in the laboratory is shown below:
Aantimicrobial sensitivity pattern of N. gonorhoea
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Antibiotics
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Total number of strain tested
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Sensitive (%)
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Resistant (%)
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Penicillin G (10 i.u.)
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8
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4 (50)
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4 (50)
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Ciprofloxacin 5mcg.
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8
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8 (100)
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0
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Nalidixic and 30mcg.
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8
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5 (62.5)
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3 (37.5)
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Tetracycline 30mcg.
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8
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6 (75)
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2 (25)
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Ceftriaxone 300mcg.
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1
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1
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Serological
diagnosis of common STI agents carried out in the STI unit
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Categories of STDs
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No. Screened
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No. positive (%)
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T. pallidum
RPR
TPHA
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1264
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125 (9.9)
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HSVI
IgG
IgM
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103
78
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79 (76.6)
0
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HSV2
IgG
IgM
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193
68
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142 (73)
2 (2.9)
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HIV
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679
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11 (1.6)
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Chalmydia
(IgG)
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88
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3 (3.4)
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HBV
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100
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40 (40)
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HCV
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100
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1 (1)
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Unit-II
Studies
in this unit were carried out for the various HIV associated infections among
individuals referred from RML Hospital, Delhi.
Storage and supply of test kits
The
division maintains two cold rooms for storage of various types of HIV test
kits, for their distribution to 238 Zonal Blood Testing Centres (ZBTCS) &
Sero-Surveillance Centres located in 9 (nine) states of Northern India. This is
done on behalf of NACO.
Supply of teaching material
Reference
Manual for Laboratory workers on “Diagnosis of Sexually Transmitted Diseases”
were distributed to RIMS – Imphal, BJMC – Ahmedabad, MMC – Chennai, BMC –
Bangalore, RFTRC – Calicut. Teaching materials for “Quality Assurance for HIV testing Laboratories in India”
distributed to participating senior scientist who attended a workshop at NICD
during November’97.
Research Projects
1. Serum cytokine profile in HIV
infection and viral load
Correlation
of cytokine profiles in various categories of HIV infection, viz. asymptomatic
& symptomatic HIV cases in relation to AIDS associated infections.
Knowledge of the relationship between disease progression (through assessment
of p24 antigen and viral DNA) and cytokine profile with pattern of HIV
infection is likely to be of benefit to clinicians in monitoring the stage of
illness and outcome of therapy in the
infected individuals, by correlating immune profile with viral load (p24
antigen and viral DNA estimation). A total of 13 such sequential samples have
been collected the under process.
2. Cross sectional studies on the
prevalence of various STD pathogens in Hospital and community.
STDs
being considered as important risk factor for acquisition of HIV and also a
co-factor for the progression of HIV infection to clinical AIDS. The knowledge
of prevalance of STDs in some high risk population and in community is also
important for the purpose of control of STDs/AIDS. Hence a cross sectional
study has been undertaken collaboration with a NGO (funded by NACO), to assess
the prevalence of various common STD pathogens in community. The red light
areas of Delhi are also envisaged be included in the study depending on
practical feasibility. Table already projected under AIDS related diseases and
STD infections, shows detailed STD serological reactivity rates.
3. Antimicrobial sensitivity pattern
of N.gonorrhoea
NICD
has been recognised as a participating centre of the WHO programme of
Gonococcal antibiotic Sensitivity pattern. For this purpose patients with
genital discharges are referred from community & hospital (Hindu Rao) STD
clinic. The summary report on this activity in 1997 has been projected.
4. Prevalence of HIV infection among
Tuberculosis patients
Tuberculosis
has re-emerged as global health crisis due to onset of HIV epidemic which has
direct correlation with HIV and as such monitoring prevalence of HIV infection
in the tuberculosis patients is very essential, in helping both TB & HIV
control programmes. AIDS division has been engaged in mass HIV screening for
the TB patients in collaboration with New Delhi TB Centre. So far 600 sera had
been tested for HIV, out of which 6 (six) were found positive.
5. Evaluation of multiple screening
tests recommended by WHO for confirmatory diagnosis of HIV infection in
comparison to conventional Western Blot.
For the
purpose of such comparison, the detailed data of testing routine serum samples
received from various surveillance centres for confirmation of HIV positive
status, are recorded for analysis to generate valuable scientific informations
regarding validity of replacing conventional WB test which is very expensive
& time consuming by multiple screening strategies as recommended by WHO.
Test results of 895 samples showed that multiple screening tests (three/two
tests) had 99.4% positive correlation with confirmatory conventional western
blot (Inno-LIA) test. Out of these, samples based on three test screening
strategy had 100% correlation while those based on two tests, had shown no
correlation with WB test.
6. Prevalence of parasitic &
viral pathogens in cases of diarrhoea among HIV/AIDS cases to explore parasitic
& viral aetiology as opportunistic pathogens.
This
will help clinicians in selecting proper line of treatment, and also will help
to study the epidemiology of HIV related diarrhoea. The laboratory procedures
for identification of one such pathogen (Cryptosporidium spp.) has been
standardized.
7. WHO sponsored Operational Research
Project for Blood Safety Testing Network
The
primary objectives of the project are i) collection of background information
of existing status of blood banks ii) Evaluation of all essential components
required for standard quality services, including biosafety iii) To run
proficiency testing programme iv) To prepare detailed strategy for quality
assurance of blood safety testing network including training of the key
laboratory personnel. For preparation of manual for evaluating status I blood
safety in blood banks, a rough draft has been prepared and referred to experts
for comments and suggested modifications etc. Regular visits have been made to
various blood banks of Delhi to collect units of blood belonging to various
categories viz. strong positives, low positives, grey zone negatives and strong
negatives for HIV, HVB and VDRL. A total of 120 such blood bags have been
collected.
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