Abbott RealTime HIV-1 Qualitative

CE Marked

For In Vitro Diagnostic Use

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).

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description
 

Today's clinical molecular diagnostics laboratory must have confidence in the quality of the HIV-1 patient results. As a result of our real-time PCR development philosophy, Abbott RealTime HIV-1 Qualitative is engineered to tolerate the genetic diversity of HIV-1 subtypes.

HIV-1 diversity can be attributed to:

  • Error-prone reverse transcriptase enzyme
  • Recombination of subtypes
  • Cross-species transmission

Detection of HIV-1 Subtypes and Groups

group/subtypes N* detected by Abbott realtime hiv-1 qualitative assay
Group M/Subtype A 10 10
Group M/Subtype B 10 10
Group M/Subtype C 10 10
Group M/Subtype D 10 10
Group M/Subtype AE 10 10
Group M/Subtype F 10 10
Group M/Subtype AG 10 10
Group M/Subtype G 10 10
Group M/Subtype H 10 10
Group O 10 10
Group N 10 10
*n represents the number of clinical specimens tested. For Group M/ Subtype H and Group N, n represents the number of replicates of transcript samples tested. The Abbott RealTime HIV-1 Qualitative assay detected all groups and subtypes tested.

Correlation to Comparator Assay

The performance of the Abbott RealTime HIV-1 Qualitative assay in detecting HIV-1 infection was evaluated by testing specimens randomly collected from infants approximately 6 weeks to 18 months old who were born to HIV-1 positive mothers. The plasma samples from 367 subjects and DBS samples from 288 subjects were tested with the Abbott RealTime HIV-1 Qualitative assay. The whole blood sample from each subject was tested with a comparator assay following instructions for use.

The overall agreement between the Abbott RealTime HIV-1 Qualitative results and the comparator assay results was 95.5% and 97.8% for the DBS and plasma assay procedures, respectively.

Intended Use

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).

The Abbott RealTime HIV-1 Qualitative is intended to be used as an aid in the diagnosis of HIV-1 infection in pediatric and adult subjects. This assay is not intended to be used as a donor screening test for HIV-1.

design
 

Assay accuracy is dependent upon a combination of:

  • Primer design
  • Probe design
  • Cycling conditions

Target Region

The Abbott RealTime HIV-1 Qualitative assay’s primers and probe are targeted to the integrase region of the polymerase gene.

Abbott RealTime HIV-1 Qualitative assay’s target region

The integrase region of the polymerase gene is a conserved region of the HIV-1 genome.


Partially Double Stranded Probe Design

Abbott RealTime HIV-1 Qualitative assay probe design

In the absence of target, the probe hybridizes to the quencher oligonucleotide, preventing fluorescent signal generation.
 

Abbott RealTime HIV-1 Qualitative assay probe design

In the presence of target, the probe prefers to hybridize with the target sequence, disassociating from the quencher oligonucleotide and allowing fluorescent detection.
 
Cycling Conditions: Low Temperature Read Cycles
 

Abbott RealTime HIV-1 Qualitative assay cycling conditions

The cycling conditions for Abbott RealTime HIV-1 Qualitative encompass a low temperature read cycle. This read cycle allows the probe to tolerate mismatches more effectively than a probe required to bind during the extension phase.
specifications
 
Abbott realtime HIV-1 Qualitative
Sensitivity 110 copies/mL for plasma samples 2,500 copies/mL for whole blood samples using the DBS procedure
Specificity 100%*
Target region Integrase region of polymerase gene
Subtype detection Group M subtypes A, B, C, D, CRF01-AE, F, CRF02-AG, G, subtype H and Group N, Group O
Internal control Non competitive armored pumpkin RNA, added to lysis buffer during extraction
Specimen Type Plasma (EDTA and ACD) Dried Blood Spots
Input volume 0.1 mL for DBS (2 spots 50 ul each), 0.2 mL for plasma
Sample preparation m2000sp 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.

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