Alere™ q HIV-1/2 Detect
Detect
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The Alere™ q HIV-1/2 Detect for Early Infant Diagnosis
A revolutionary point of care nucleic acid amplification test for the detection of HIV-1 and HIV-2.
This simple yet smart assay provides next generation virological HIV-1 and HIV-2 results at the point of care within 52 minutes. Perfectly suited for the challenges of virological testing in infants and adults in resource limited settings.
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Any photos displayed are for illustrative purposes only.
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Simple yet Smart
Virological testing is necessary to detect a HIV infection in newborns. Traditionally these virological assays have required skilled technicians in a laboratory setting often leading to delays in results for mothers and infants.
Now with the revolutionary Alere™ q HIV-1/2 Detect Test, this sophisticated assay can be automatically performed at the point of care, without requiring specialist skills. Only 25 μL of peripheral blood is required to deliver lab accurate results for the detection of HIV-1 and HIV-2 in less than an hour.
The use of whole blood ensures cell-associated viral particles are included in the analysis, providing a higher probability of detecting a HIV infection in newborns and improving patient outcomes.
The use of whole blood ensures cell-associated viral particles are included in the analysis, providing a higher probability of detecting a HIV infection in newborns and improving patient outcomes.
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How the Assay Works
Once the patient sample has been collected into the cartridge, the cartridge is closed and placed into the Alere™ q analyzer and the assay automatically commences.
The sample processing starts with a nucleic acid extraction utilizing chaotropic salts, heat and mechanical disruption. This allows hybridization of oligonucleotides complementary to specific sequences of the HIV-1 and HIV-2 genome. These sequence specific capture oligonucleotides carry a 3’-terminal biotin-residue. In the next step the biotin-residues interact with Streptavidin-coated Sepharose particles, consequently binding any HIV-mRNA bound to a capture oligonucleotide onto the Sepharose matrix too. Washing of these Sepharose particles then yields highly purified un-spliced messenger RNA (mRNA) specific to HIV-1 or HIV-2.
The captured mRNA cannot be detected directly. It is therefore reverse transcribed into complementary DNA (cDNA) and the mRNA-cDNA hybrid is then separated to make the cDNA accessible for amplification by PCR. The PCR cycle, including denaturation, annealing and elongation is repeated 45 times to ensure even low levels of HIV-1 and HIV-2 can be detected.
Detection is based on Competitive Reporter Monitored Amplification (CMA) technology utilizing an array of immobilized oligonucleotide probes and complementary fluorescently labeled reporter oligonucleotides in solution1. The integrity of each assay step is ensured through the presence of internal standards and controls that runs concurrently with each test performed. The analysis algorithm delivers qualitative results for HIV-1 M/N and O and HIV-2 in the sample.
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Alere™ q HIV-1/2 Detect Cartridge
The Alere™ q HIV-1/2 Detect Test cartridge contains all the dried reagents and buffers required, in separate chambers, to perform the nucleic acid amplification test. For the duration of the test, the reagents, buffers and waste products remain within the microfluidic network of the sealed cartridge. The cartridge and its content can be shipped and stored at room temperature removing the complexity of cold chain logistics.
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Simple Procedure Reliable Results
Blood is collected from the patient through either a finger or heel prick sampling technique, or venous blood draw, and applied directly onto the cartridge.
The sample volume of 25 μL is visualized by the control window and once the cartridge cap is closed it is completely sealed and there is no risk of sample spillage or instrument contamination.
The sealed cartridge is inserted into the Alere™ q and the test is initiated automatically. The operator is prompted to enter patient details using the large color touch screen.
The Alere™ q automatically operates the intricate embedded microfluidic network contained in the cartridge to perform the assay.
Integrated cartridge QC, including internal standards, ensures lab accurate results for the detection of HIV-1 and HIV-2 are delivered at the point of care in 52 minutes.
Load Sample
Transfer 25 μL of sample into the cartridge.
Check
View the control window to ensure sufficient sample loading. Completely close the cartridge cap to seal the system.
Run Test
Insert the sealed Alere™ q HIV-1/2 Detect cartridge into the Alere™ q analyser. Result in 52 minutes.
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References
- Ullrich T, Ermantraut E, Schulz T, et al. Competitive Reporter Monitored Amplification (CMA) -Quantification of Molecular Targets by Real Time Monitoring of Competitive Reporter Hybridization. PLoS ONE 2012, 7(4): e35438. doi:10.1371/journal.pone.0035438
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