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PQDx 0027-012-00 WHO PQDx PR May/2013, version 2.0 WHO Prequalification of Diagnostics Programme PUBLIC REPORT Product: SD BIOLINE HIV-1/2 3.0 Number: PQDx 0027-012-00 Abstract SD BIOLINE HIV-1/2 3.0 with product codes 03FK10, and 03FK16, manufactured by Standard Diagnostics, Inc., “rest of the world” regulatory version (non CE-marked), was accepted for the WHO list of prequalified diagnostics and was listed on 20 May 2013. SD BIOLINE HIV 1/2 3.0 kit is a rapid, qualitative test for the detection of antibodies to certain isotypes (IgG, IgM, IgA) specific to HIV-1 including subtype-O and HIV-2 simultaneously in human serum, plasma or whole blood. SD BIOLINE HIV-1/2 3.0 test contains a membrane strip, which is pre-coated with recombinant HIV-1 capture antigen (gp41, p24) on test line “1” region and with recombinant HIV-2 capture antigen (gp36) on test line “2” region, respectively. The mixture (recombinant HIV-1/2 antigen (gp41, p24 and gp36) - colloid gold conjugate and the specimen moves upward on the membrane chromatographically to the test region (T) and form a visible line as the antigen antibody-antigen gold particle complex forms with high degree of sensitivity and specificity. This test device has the letter of 1, 2 and C as Test Line 1 (HIV-1), Test Line 2 (HIV-2) and Control Line on the surface of the device. All test lines and the control line in the result window should not be visible before applying any sample. The control line is used as a procedural control for the addition of reagents and may still appear if no specimen is added to the test device. SD BIOLINE HIV-1/2 3.0 is intended as an aid in the diagnosis of infection with HIV-1/2. Special note : The reading time for this product has changed, the revised instructions for use now state: “Time to result is 10 to 20 minutes. After adding the diluent, read the result after 10 minutes but not more than 20 minutes.” Caution: If the test result is not legible after 10 minutes due to high background color, read again later but within 20 minutes of adding the diluent. Do not read after 20 minutes. PQDx_107 Page 1 of 10 PQDx 0027-012-00 WHO PQDx PR May/2013, version 2.0 Caution : Dual infection of HIV-1 and HIV-2 within one individual is quite rare. Dual reactivity observed in SD BIOLINE HIV-1/2 3.0, i.e. HIV-1 line and HIV-2 line both reactive, is more likely to be caused by cross-reactivity given certain homology in the amino acid sequences of HIV-1 and HIV-2. To determine the virus type or diagnose a co-infection, confirmatory testing must be performed. The test kit is marketed the following different configurations: 1. SD BIOLINE HIV-1/2 3.0 [30 Tests/kit] product code. 03FK10: • 30 test devices individually foil pouched with a desiccant • Assay diluent (1 x 4ml/vial) • Instructions for use 2. SD BIOLINE HIV-1/2 3.0 [25 Tests/kit] Cat. No. 03FK16: • 25 test devices individually foil pouched with a desiccant • Assay diluent (1 x 4ml/vial) • 25 x capillary pipettes, 25 x lancets, 25 x alcohol swabs • Instructions for use Storage: The test kit should be stored at 1 - 30 °C. Shelf-life: 24 months. Summary of prequalification status for SD BIOLINE HIV-1/2 3.0 Initial acceptance Date Outcome Status on PQ list 20 May 2013 listed Dossier assessment 11 August 2011 MR Inspection status 19 February 2013 MR Laboratory evaluation 05 April 2013 MR MR: Meets Requirements NA: Not Applicable SD BIOLINE HIV-1/2 3.0 was accepted for the WHO list of prequalified diagnostics on the basis of data submitted and publicly available information. PQDx_107 Page 2 of 10 PQDx 0027-012-00 WHO PQDx PR May/2013, version 2.0 Background information Standard Diagnostics, Inc. submitted an application for prequalification of SD BIOLINE HIV- 1/2 3.0. Based on the established prioritization criteria, SD BIOLINE HIV-1/2 3.0 was given priority for prequalification. Product dossier assessment Standard Diagnostics, Inc. submitted a product dossier for SD BIOLINE HIV-1/2 3.0 as per the Instructions for compilation of a product dossier (PQDx_018 v1). The information submitted in the product dossier was reviewed by WHO staff and external experts (assessors) appointed by WHO in accordance with the internal report on the screening and assessment of a product dossier (PQDx_009 v2). Based on the product dossier screening and assessment findings, a recommendation was made to accept the product doss

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