HIV-1 QUALITATIVE

Abbott RealTime HIV-1 Qualitative

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The Abbott RealTime HIV-1 Qualitative is an in vitro amplification assay for the qualitative detection of Human Immunodeficiency Virus Type 1 (HIV-1) nucleic acids from human plasma and dried blood spots (DBS).

To learn more about Abbott RealTime HIV-1 Qualitative please visit: https://www.molecular.abbott/int/en/products/infectious-disease/realtime-hiv-1-qualitative

ABBOTT REALTIME HIV-1 QUALITATIVE
Sensitivity110 copies/mL for plasma samples 2,500 copies/mL for whole blood samples using the DBS procedure
Specificity100%*
Target regionIntegrase region of polymerase gene
Subtype detectionGroup M subtypes A, B, C, D, CRF01-AE, F, CRF02-AG, G, subtype H and Group N, Group O
Internal controlNon competitive armored pumpkin RNA, added to lysis buffer during extraction
Specimen TypePlasma (EDTA and ACD) Dried Blood Spots
Input volume0.1 mL for DBS (2 spots 50 ul each), 0.2 mL for plasma
Sample preparationm2000sp Manual Sample Preparation

*The specificity of the Abbott RealTime HIV-1 Qualitative assay was evaluated for both the plasma and DBS procedures by testing 550 HIV-1 seronegative plasma specimens and 550 HIV-1 seronegative whole blood specimens. Both plasma and whole blood specimens were collected from each of the 550 subjects. For each assay procedure, the specimens were tested on two Abbott m2000sp and m2000rt instrument pairs with four lots of amplification reagents. HIV-1 was not detected for 550 out of 550 samples in both specimen types, resulting in 100.0% specificity (95% CI 99.33 - 100.00%) for both the plasma and DBS assay procedures in this representative study.