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Year : 2003  |  Volume : 21  |  Issue : 3  |  Page : 193-195

Performance evaluation of four different kits available in the Indian market, for the rapid detection of HIV antibody

Department of Clinical Virology, Christian Medical College, Vellore - 632 004, Tamilnadu, India

Correspondence Address:
Department of Clinical Virology, Christian Medical College, Vellore - 632 004, Tamilnadu, India

 ~ Abstract 

The performance of four rapid human immunodeficiency virus (HIV) antibody screening assays was evaluated on an established panel of samples. All the assays showed 100% sensitivity and specificities in the range of 98.6-100%. These tests can safely be used for screening at centres in India where facilities are limited.

How to cite this article:
Kannangai R, Prabu K, Vincent A A, Vijayakumar T S, Sridharan G. Performance evaluation of four different kits available in the Indian market, for the rapid detection of HIV antibody. Indian J Med Microbiol 2003;21:193-5

How to cite this URL:
Kannangai R, Prabu K, Vincent A A, Vijayakumar T S, Sridharan G. Performance evaluation of four different kits available in the Indian market, for the rapid detection of HIV antibody. Indian J Med Microbiol [serial online] 2003 [cited 2021 Mar 5];21:193-5. Available from:

Detection of antibody against human immunodeficiency virus (HIV) is continuing to be the mainstay of diagnosis of HIV infection.[1] Though ELISAs of acceptable standard are available, requirement of equipment like ELISA washer and reader may limit their availability to certain laboratories. Clinical situations like emergency invasive procedures, labour room procedures for unscreened women, availability of cadaver-organ-donor warrant rapid testing. Rapid tests also play a major role in screening individuals, in primary health centers where infrastructure may be limited as is common in resource poor setting like India. Unlike in western countries, in the Indian subcontinent, where epidemic of both HIV 1 and HIV 2 infections are ongoing,[2] it is important to use tests which can detect both these viruses. Hence, it becomes mandatory to evaluate the kits with samples collected locally before introducing into the local market. We report here an evaluation of four rapid screening assays for HIV antibody in serum or plasma samples.

 ~ Materials and methods Top

The four kits evaluated were the SD BIOLINE HIV 1 / 2 3.0 (Standard Diagnostics, Inc Kyonggi-do Korea), Qualpro's rapid immunoconcentration test for HIV 1 & 2 (Qualpro Diagnostics, Goa, India), Qualpro's rapid test HIV 1 / 2 (Qualpro Diagnostics, Goa, India) and the CombAids-RS (Span Diagnostics Ltd, Surat, India). Except for one, all the kits were manufactured indigenously. Details of the principle and capability to differentiate between HIV 1 and 2 of the kits are given in [Table - 1].
The evaluation panel consisted of 100 serum / plasma samples collected at the department of clinical virology, Christian Medical College, Vellore.

 ~ Results Top

Seventy out of 100 samples tested HIV negative by two ELISA systems, the Genedia HIV 1 / 2 3.0 (Korean Green Cross, Kyonggi-do Korea), a 3rd generation ELISA and the Microlisa HIV (J Mitra & Co. Ltd., New Delhi, India) a 2nd generation ELISA. All the 30 HIV positive samples were confirmed by immunoblot, INNOLIA HIV confirmation, (Innogenetics NV, Zwijndrecht, Belgium). Among the positive samples 25 were HIV-1 positive, 3 were positive for HIV 2 and 2 were positive for both HIV 1 and HIV 2 by the immunoblot. The dual positivity of the two samples by immunoblot were confirmed by HIV 1 and HIV 2 specific DNA PCR.[3],[4] All these sera were stored at -20C and subjected to a maximum of two freeze thaw cycles. The manufacturer's testing protocol instructions were strictly followed and results were interpreted only when the controls were satisfactory.
The accuracy indices of the 4 kits evaluated are given in [Table - 2]. All the 4 kits showed 100% sensitivity. Except CombAids all were 100% specific on the tested panel. The specificity of CombAids was 98.6%.

 ~ Discussion Top

All the four kits evaluated in this study showed 100% sensitivity and detected all the three HIV-2 positive samples. The two kits, SD BIOLINE HIV 1 / 2 3.0 and Qualpro's rapid immunoconcentration test which can discriminate HIV-1 and HIV-2 were able to discriminate the same in all the positive samples tested. In all the above tests the results were ready in 20-30 minutes. These tests were very easy to perform, as all the reagents were ready to use and tests can be performed as and when samples are available, except in CombAids. In CombAids the user has to prepare the working wash solution from the given concentrate and dilution plates are required for sample dilution. In addition, since each comb requires the use of a positive and negative control, it would be economical only when samples are tested in batches. The advantage of the two kits based on immunochromatography, SD BIOLINE HIV 1 / 2 3.0 and the Qualpro's rapid HIV 1 / 2 test is that they can detect IgM antibody as well as IgG. This will enable these kits to reduce the serological window period by one week in HIV infected individuals. Another advantage of SD BIOLINE HIV 1 / 2 3.0 apart from being a 3rd generation kit is that it can differentiate between HIV-1 and HIV-2. The accuracy indices of these four rapid tests were found to be satisfactory in the panel of sera / plasma tested. These tests have advantages like ease of use, requirement of minimal training of user, easy interpretation, and a good shelf life and hence these tests can be used as an alternative to ELISA tests in small peripheral hospitals, blood banks, and voluntary counselling and testing centres.  

 ~ References Top

1.Henrard D, Reichelderfer. Assays for the diagnosis of HIV infection. In: Textbook of AIDS Medicine Eds. Merigan TC, Barlett JG, Bolognesi D. (Williams & Wilkins, Baltimore). 1999; 661-672.  Back to cited text no. 1    
2.Rubsamen Waigmann H, Brisen HV, Maniar JK, Pao PK Scholz C, Pfutzner A. Spread of HIV-2 in India. Lancet 1991;337:550.  Back to cited text no. 2    
3.Delwart EL, Hering B, Rodrigo AG, Mullins JI. Genetic subtyping of Human immunodeficiency virus using hetero duplex mobility assay. PCR Meth Appl 1995;4: S202-S216.  Back to cited text no. 3    
4.Kannangai R, Ramalingam S, Prakash KJ, Abraham OC, George R, Castillo RC, Schwartz DH, Jesudasan MV, Sridharan G. Molecular confirmation of human immunodeficiency virus (HIV) type-2 in HIV- seropositive subjects in south India. Clin Diagn Lab Immunol 2000;7: 987-89.  Back to cited text no. 4    
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2004 - Indian Journal of Medical Microbiology
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