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M2000 real time hiv 1 assay

Manufactured by Abbott
Sourced in United States

The Abbott M2000 Real-Time HIV-1 Assay is a laboratory-based diagnostic tool used for the detection and quantification of HIV-1 RNA in human plasma and serum samples. The assay utilizes real-time PCR technology to provide accurate and reliable results for the monitoring of HIV-1 viral load.

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15 protocols using m2000 real time hiv 1 assay

1

Obstetric and Infant HIV Care Protocol

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Women had an obstetrical examination and hematologic and biochemical testing every month until delivery. After delivery, they were seen at 7–10 days, 1 and 6 months for physical examination and laboratory tests. VL (Abbott m2000 RealTime© HIV-1 assay) and CD4 cell count were measured at baseline and delivery. C-section was planned upon decision of the obstetrical team, following the national guidelines [1 ]. Also by Thai guidelines, women were advised not to breastfeed, and formula milk was provided to mothers who, in the judgment of the medical team, would have difficulty purchasing it [1 ].
Infants were examined at birth, 7–10 days, one, two, four and six months. At each visit, the child’s interval history was recorded and a physical examination performed. Blood was obtained for HIV diagnosis at birth (within 24 hours), 7–10 days, one, two, four and six months, hematology at birth, 7–10 days and 1 month, and chemistry at birth and 7–10 days.
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2

Viral Suppression after ART Initiation

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We defined viral suppression as a viral load < 1000 copies/mL drawn at least 5 and a half months (166 days) after starting ART, following the 2018 Malawian ART guidelines. Viral load testing was performed at Bwaila Hospital in Lilongwe using collected plasma or dried blood spots and processed by Abbott m2000 RealTime HIV-1 assay instruments [41 ].
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3

Measuring Immune Status and Viral Load

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Absolute blood CD4+ T cell counts were measured using a Flow-CARE PLG CD4 test (Beckman Coulter). For HIV-infected individuals, plasma HIV-1 RNA levels were quantified using Abbott m2000 RealTime HIV-1 assay. For HLA typing, DNA was extracted from peripheral blood mononuclear cells (PBMC) using the QIAamp Mini Blood kit (Qiagen). High-resolution HLA class II genotypes were determined using 454/Fluidigm HLA Typing Kits (Roche) following the manufacturer’s protocols (16 (link)).
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4

Maternal HIV-RNA Monitoring During Prophylaxis

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In all studies the maternal HIV-RNA measurement was planned prior to antiretroviral prophylaxis/treatment initiation to assess risk factors of transmission. In PHPT-1 and PHPT-2, VL samples were primarily collected for measurements at entry and delivery, while for PHPT-5, VL was measured monthly to assess HIV-RNA kinetics on antiretroviral drugs.
Plasma VL was assessed at the central PHPT laboratory in Chiang Mai University. Samples from PHPT-1 and PHPT-2 studies were tested using Cobas Amplicor HIV-1 Monitor kit version 1.5 (Roche Molecular Systems, USA) with a limit of quantification of 400 copies/mL; and samples from PHPT-5 first phase using the Abbott m2000 RealTime© HIV-1 assay (limit of quantification 40 copies/mL).
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5

Quantifying HIV-1 Viral Load

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Viral load was determined using the Abbott m2000 RealTime HIV-1 assay as per the manufacturer's instructions (Abbott Molecular), which has been demonstrated to assess CRF02_AG samples accurately. Briefly, the m2000 RealTime HIV-1 assay performs automated extraction (input volume of 0.6 mL, m2000sp apparatus), real-time polymerase chain reaction (PCR) amplification of the integrase gene fragment, and noncompetitive fluorescent detection (m2000rt instrument, dynamic range of 40–107 copies/mL).
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6

Abbott HIV-1 Viral Load Quantification

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Viral load was determined using the Abbott m2000 RealTime HIV-1 assay as per the manufacturer’s instructions (Abbott Molecular, Des Plaines, IL).
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7

Perinatal HIV Transmission Evaluation

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Women had an obstetrical, hematologic, and biochemical evaluation at enrollment. HIV-RNA VL (Abbott m2000 RealTime© HIV-1 assay; Abbott Molecular Inc., Des Plaines, IL; limit of quantification 40 copies/mL) and CD4 cell count were measured at baseline and delivery.
Infants were examined at birth and 2 weeks, 1, 2, 4, and 6 months of life. The child’s interval history was recorded, a physical examination performed, and blood obtained for HIV-DNA testing by real-time polymerase chain reaction (PCR) assay on peripheral blood spotted onto filter papers, dried, and stored at −20°C.13 (link) Hematology and chemistry tests were performed soon after birth, at 2 and 4 weeks.
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8

Quantitative Analysis of HIV-1

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CD4+ T lymphocyte counts were determined from the patients’ whole blood by flow cytometry using BD FACSCalibur (BD, USA), according to the manufacturer’s instructions, and data were analyzed using Multiset™ (BD, USA). A quantitative analysis of HIV-1 RNA in plasma was performed according to the manufacturer’s instructions using Abbott M2000 RealTime HIV-1 assay (Abbott Molecular, Inc., Des Plaines, IL, USA).
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9

HIV RNA Detection Protocol

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Specimens underwent HIV RNA PCR testing using the COBAS® AMPLICOR HIV-1 MONITOR Test (Roche, Pleasonton, CA) (reportable range of 50 to 750,000 copies/ml) or Abbott RealTime HIV-1 m2000 Assay (Abbott Laboratories, Chicago, IL) (reportable range of 40 to 10,000,000 copies/ml). Microtubes containing whole blood were processed and plasma specimens were pooled in a 9:1 pooling algorithm. Positive pools were deconstructed and individual specimens tested to identify which contained detectable HIV RNA28 (link)–31 (link).
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10

HIV RNA Viral Load Testing

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Specimens underwent HIV RNA polymerase chain reaction (PCR) testing using the COBAS AMPLICOR HIV-1 MONITOR Test (Roche, Pleasanton, CA) (reportable range of 50–750,000 copies/mL) or Abbott RealTime HIV-1 m2000 Assay (Abbott Laboratories, Chicago, IL) (reportable range of 40–10,000,000 copies/mL). Microtubes containing whole blood were processed and plasma specimens were pooled in a 9:1 pooling algorithm. Positive pools were deconstructed and individual specimens tested to identify which contained detectable HIV RNA.28 (link)–31 (link)
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