Alinity M CMV Assay - Abbott Molecular

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1. Alinity m CMV Assay

ALINITY m CMV ASSAYS

ALINITY m CMV WB ASSAY (WHOLE BLOOD)

ALINITY m CMV ASSAY (PLASMA)

 

For In Vitro Diagnostic Use.

ABBOTT'S HIGH PERFORMING TESTING AT DECISIVE MOMENTS IN TRANSPLANT PATIENT CARE

 

 

CMV testing on the Alinity m system delivers accurate and timely viral load results, which helps clinicians guide patient care with confidence.

 

Instructions For Use VIEW ORDERING INFORMATION

Improved Operational Efficiency

• Alinity m is a continuous and random-access molecular analyzer with a time to first result of less than ~ 115 minutes that provides the ability to eliminate batching procedures and lead to improved laboratory workflow
• Random access and STAT prioritization provide timely results that support clinicians in their decision to initiate and manage treatment effectively

Improved Confidence

• Dual-target assay design helps provides robust, accurate and sensitive detection of Cytomegalovirus (CMV) from plasma or whole blood sample types
• Assay is standardized to the 1st World Health Organization (WHO) International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC Code: 09/162)
• Alinity m provides the ability to test Cytomegalovirus (CMV) and Epstein-Barr Virus (EBV) from a single plasma or whole blood sample, which is critical for transplant patients who are at risk of developing coinfections

CMV (PLASMA) INTENDED USE CMV (WB) INTENDED USE SPECIFICATIONS

CMV (Plasma)

The Alinity m CMV assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to detect and quantitate cytomegalovirus (CMV) DNA in human plasma. The Alinity m CMV assay is intended for use as an aid in the diagnosis and management of CMV in transplant patients and other immunocompromised patients. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in CMV DNA levels in plasma. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for CMV.

Limitations

• Optimal performance of this test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the package insert).
• Human plasma (K2 EDTA, K3 EDTA, and PPT) specimens may be used with the Alinity m CMV assay. The use of other plasma tubes have not been evaluated.
• Debris within plasma specimens (eg, fibrin strands) may interfere with sample processing.
• The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in the package insert.
• If the CMV results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
• A specimen with a result of “Not Detected” cannot be presumed to be negative for CMV DNA.
• When serially monitoring the CMV viral load in patients, 1 specimen type should be used throughout the monitoring period. Follow institutional/society guidelines as appropriate.
• Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform method correlation studies in their laboratory to qualify technology differences. Users should follow their own specific policies/procedures.

CMV Whole Blood

The Alinity m CMV WB assay is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to detect and quantitate cytomegalovirus (CMV) DNA in human whole blood.

The Alinity m CMV WB assay is intended for use as an aid in the diagnosis and management of CMV in transplant patients and other immunocompromised patients. The assay is intended for use in conjunction with clinical presentation and other laboratory markers as an indicator of initiation of therapy and for use as an aid in monitoring viral response to antiviral treatment as measured by changes in CMV DNA levels in whole blood. This assay is not intended to be used in screening blood, blood products, tissue or organ donors for CMV.

Limitations

• Optimal performance of this test requires appropriate specimen collection and handling (refer to the SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS section of the package insert).
• Human whole blood (K2 EDTA or K3 EDTA) specimens may be used with the Alinity m CMV WB assay. The use of other specimen types or collection tubes has not been evaluated.
• The instruments and assay procedures reduce the risk of contamination by amplification product. However, nucleic acid contamination from the calibrators, positive controls, or specimens must be controlled by good laboratory practice and careful adherence to the procedures specified in the package insert.
• If the CMV results are inconsistent with clinical evidence, additional testing is suggested to confirm the result.
• A specimen with a result of “Not Detected” cannot be presumed to be negative for CMV.
• When serially monitoring the CMV viral load in patients, 1 specimen type should be used throughout the monitoring period. Follow institutional/society guidelines as appropriate. 
• Due to inherent differences between technologies, it is recommended that, prior to switching from one technology to the next, users perform method correlation studies in their laboratory to qualify technology differences. Users should follow their own specific policies/procedures.

The Alinity m CMV WB AMP Kit is an in vitro diagnostic device which is CE-marked. Notified body number 2797.

Assay	Alinity m CMV and Alinity m CMV WB
Technology	Real-time PCR
Assay Run Time	< ~115 min time to first result
Throughput	300 samples in ~8 hours
Probe Design	Single-stranded probe design
Target Regions	UL34 and UL80.5
Results Units	IU/mL or Log (IU/mL)
Standardization	1st World Health Organization (WHO) International Standard for Human Cytomegalovirus for Nucleic Acid Amplification Techniques (NIBSC code: 09/162)
Internal Control	Yes
External Controls	Negative, Low Positive, High Positive
Calibrators	2 calibrator levels (single-use tubes)
Plasma Sample Types (09N46-090)	Plasma K2 EDTA; K3 EDTA; Plasma Preparation Tubes (PPTs)
Plasma Input Volume (Aspirated)	500 µL
Plasma Limit of Detection (LOD)	LoD = 30 IU/mL Probit analysis of the data determined that the concentration of CMV DNA in plasma detected with 95% probability was 18.98 IU/mL(95% CI: 11.16 to 62.82 IU/mL)
Plasma Linear Range	1.48 Log IU/mL to 8.00 Log IU/mL
Plasma Precision	≤ 0.25 Log IU/mL Standard Deviation from 2.70 to 8.00 Log IU/mL; ≤ 0.50 Log IU/mL Standard Deviation from 1.70 Log IU/mL to < 2.70 Log IU/mL.​
Whole blood Sample Types (09N43-092)	Whole blood K2 EDTA; K3 EDTA
Whole blood Input Volume (Aspirated)	500 µL
Whole blood Limit of Detection (LOD)	100 IU/mL (2.00 Log IU/mL)
Whole blood Linear Range	2.00 Log IU/mL to 8.00 Log IU/mL
Whole blood Precision	≤0.25 Log IU/mL from 3.00 to 8.00 Log IU/mL; ≤0.50 Log IU/mL from 2.00 Log IU/mL to <3.00 Log IU/mL

ALINITY M CMV

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ALINITY M CMV WB (WHOLE BLOOD)

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Accord Semi-Automatic Scanner (Manual Stage)

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• Algeria
• Angola
• Anguilla
• Antigua And Barbuda
• Argentina
• Armenia
• Aruba
• Australia
• Austria
• Azerbaijan
• Bahamas
• Bahrain
• Bangladesh
• Barbados
• Belarus
• Belgium
• Belize
• Benin
• Bermuda
• Bhutan
• Bolivia
• Bonaire St. Eustatius And Saba
• Bosnia And Herzegovina
• Botswana
• Brazil
• British Virgin Islands
• Bulgaria
• Burkina Faso
• Burundi
• Cambodia
• Cameroon
• Canada
• Cape Verde
• Cayman Islands
• Central African Republic
• Chad
• Chile
• China
• Colombia
• Comoros
• Cook Islands
• Costa Rica
• Cote D'Ivoire
• Croatia
• Cuba
• Curacao
• Cyprus
• Czech Republic
• Democratic Peoples Republic Of Korea
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• Djibouti
• Dominica
• Dominican Republic
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• Georgia
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• Greece
• Greenland
• Grenada
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• Guam
• Guatemala
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• Guinea-Bissau
• Guyana
• Haiti
• Honduras
• Hong Kong
• Hungary
• Iceland
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• Indonesia
• Iran
• Iraq
• Israel
• Italy
• Jamaica
• Japan
• Jordan
• Kazakhstan
• Kenya
• Kiribati
• Kosovo
• Kuwait
• Kyrgyzstan
• Lao People's Democratic Republic
• Latvia
• Lebanon
• Lesotho
• Liberia
• Libya
• Lithuania
• Luxembourg
• Macedonia
• Madagascar
• Malawi
• Malaysia
• Maldives
• Mali
• Malta
• Martinique
• Mauritania
• Mauritius
• Mexico
• Moldova
• Mongolia
• Montenegro
• Montserrat
• Morocco
• Mozambique
• Myanmar
• Namibia
• Nepal
• Netherlands
• New Caledonia
• New Zealand
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• Niger
• Nigeria
• Norway
• Oman
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• Panama
• Papua New Guinea
• Paraguay
• Peru
• Philippines
• Poland
• Portugal
• Puerto Rico
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• Republic Of Ireland
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• Republic Of The Congo
• Reunion
• Romania
• Russian Federation
• Rwanda
• Saint Kitts And Nevis
• Saint Lucia
• Saint Maarten
• Saint Vincent And The Grenadines
• Samoa
• Sao Tome And Principe
• Saudi Arabia
• Senegal
• Serbia
• Seychelles
• Sierra Leone
• Singapore
• Slovakia
• Slovenia
• Solomon Islands
• Somalia
• South Africa
• Spain
• Sri Lanka
• Sudan
• Suriname
• Swaziland
• Sweden
• Switzerland
• Syrian Arab Republic
• Taiwan
• Tajikistan
• Tanzania
• Thailand
• The Democratic Republic Of The Congo
• Timor-Leste
• Togo
• Trinidad And Tobago
• Tunisia
• Turkey
• Turks And Caicos Islands
• Tuvalu
• Uganda
• Ukraine
• United Arab Emirates
• United Kingdom
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• Viet Nam
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• Zimbabwe

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