Testing for ZIKV RNA was done at the SSO using the licensed cobas Zika nucleic acid test (cobas Zika), with a 95% limit of detection (LOD) of 8.1 copies per milliliter (c/mL) (95% CI: 6.1-13.6 c/mL) on the cobas 8800 System (RMS)13 . Each sample was tested one-time individually. One of 1,278 samples tested initial ZIKV-reactive on the cobas 8800 System. This sample was retested once on the cobas 8800 System using the reactive sample tube. A paired serum sample was sent to the Wadsworth Center (New York State Department of Health) for ZIKV-IgM MAC-ELISA testing. Additionally, the amplification-detection (AD) plate for the initial cobas Zika reactive sample was sent to RMS for evaluation of amplicons by heminested (hn) PCR. The plasma sample was also tested using the Procleix Zika Virus Assay on the Procleix Panther System (Grifols Diagnostic Solutions Inc., San Diego, CA) with a 95% LOD of 3.9 c/mL (95% CI 3.2 – 4.8 c/mL)14 . The donation was considered confirmed positive based on repeat cobas Zika reactivity, hnPCR positivity and Procleix reactivity.
Procleix panther system
Manufactured by Grifols
Sourced in United States
The Procleix Panther System is a fully automated instrument designed for the detection of nucleic acids in biological samples. It provides a standardized and efficient approach to sample processing, amplification, and detection, ensuring reliable and consistent results.
Automatically generated - may contain errors
Lab products found in correlation
4 protocols using procleix panther system
1
ZIKV RNA Testing Protocols Evaluation
2
DENV RNA Detection Across Outbreaks
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The following samples were tested for the presence of DENV RNA: 664 samples from higher-risk areas during the 2008/2009 DENV outbreak (representing all samples remaining with an adequate volume); 5,518 samples from the 2012/2013 DENV outbreak; and 1,601 control samples from southern Australia. Samples were tested with a Procleix DENV assay on a Procleix Panther System (Grifols Diagnostic Solutions, Inc., Emeryville, CA, USA, and Hologic, San Diego, CA, USA) as per manufacturer's instructions, which included positive, negative, and internal controls, at the American Red Cross laboratories in Charlotte, North Carolina. The Procleix DENV assay is based on transcription mediated amplification (TMA) and can detect all four DENV serotypes [4 (link)]. The 95% limit of detection is reported to be approximately 15 copies/mL (95% CI, 11.5–20.9 copies/mL), with a specificity of >99.91% [4 (link)].
3
Dried Blood Spot HCV Surveillance
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Dried blood spot (DBS) samples were collected from all consenting participants after completing the interview as previously described [22 (link)]. DBS were not used routinely in prisons in Denmark during the study period. The DBS were obtained on Whatman 903 protein saver card (Sigma-Aldrich, Copenhagen, Denmark) and were allowed to dry for 1 to 3 days before they were eluted and tested for anti-HCV using the Architect System (Abbott Diagnostics, Delkenheim. Germany). Serology positive samples were tested for the presence of HCV RNA by Nucleic Acid Amplification Testing using multiple primers and the Procleix Panther System (Grifols Diagnostic Solutions, Allschill, Switzerland). Remaining blood spot samples on the Whatman card were stored at -80°C.
To test for incidence, all samples were tested for the presence of HCV RNA in pools of five and samples in positive pools were tested individually. The DBS samples were thawed and eluted by incubating with 1,150 μL SPER buffer (Roche Diagnostics, Basel, Switzerland) for 10 min at 56°C on a thermomixer (shaking at 1,000 rpm) and the testing was performed using the cobas MPX assay at the cobas6800 system (Roche Diagnostics, Basel, Switzerland).
To test for incidence, all samples were tested for the presence of HCV RNA in pools of five and samples in positive pools were tested individually. The DBS samples were thawed and eluted by incubating with 1,150 μL SPER buffer (Roche Diagnostics, Basel, Switzerland) for 10 min at 56°C on a thermomixer (shaking at 1,000 rpm) and the testing was performed using the cobas MPX assay at the cobas6800 system (Roche Diagnostics, Basel, Switzerland).
4
Evaluation of HIV-1 Plasma Specimens
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Eighty-nine HIV-1-positive plasma specimens that had been declared ineligible for transfusion were provided by the Japanese Red Cross Blood Centers from 2013 through 2015. The specimens were evaluated using cobas TaqScreen HIV on cobas s 401 (Roche Molecular Systems, Inc., NJ, USA) or Procleix Ultrio Elite ABD assay on Procleix PANTHER System (Grifols Diagnostic Solutions, CA, USA), and decided HIV-1-positive by the discriminatory assay. The specimens were provided following an application for the use of blood donated in Japan, based on the guidelines on the use of donated blood in research and development. The information of the specimens was anonymized, and a decoding index was not created. Ethical approval was obtained from the Ethical Committee of the National Institute of Infectious Diseases (No. 1082).
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