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ALINITY m EBV ASSAYS

ALINITY m EBV WB ASSAY (WHOLE BLOOD)
ALINITY m EBV ASSAY (PLASMA)

 

For In Vitro Diagnostic Use.

ALINITY m EBV ASSAY image
ALINITY m EBV ASSAY image
ALINITY m EBV ASSAY image



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

Instructions For Use
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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 Epstein-Barr Virus (EBV) from plasma or whole blood sample types
  • Assay is standardized to the 1st World Health Organization (WHO) International Standard for EBV for Nucleic Acid Amplification Techniques (NIBSC code 09/260)
  • 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

EBV Plasma

Alinity m EBV is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Epstein-Barr Virus (EBV) DNA in human EDTA plasma. Alinity m EBV is intended for use as an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment. The results from Alinity m EBV must be interpreted within the context of all relevant clinical and laboratory findings. Alinity m EBV is not intended to be used in screening blood, blood products, tissue, or organ donors for EBV.

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 EBV assay. The use of other plasma tubes has 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 EBV 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 EBV.
  • Results from the Alinity m EBV assay should be interpreted in conjunction with other clinical laboratory findings.

EBV Whole Blood

Alinity m EBV WB is an in vitro polymerase chain reaction (PCR) assay for use with the automated Alinity m System to quantitate Epstein-Barr Virus (EBV) DNA in human whole blood.

Alinity m EBV WB is intended for use as an aid in the diagnosis and management of EBV in transplant patients and other immunocompromised patients. In patients undergoing monitoring of EBV, serial DNA measurements can be used to indicate the need for potential treatment changes and to assess viral response to treatment.

The results from Alinity m EBV WB must be interpreted within the context of all relevant clinical and laboratory findings. Alinity m EBV WB is not intended to be used in screening blood, blood products, tissue or organ donors for EBV.

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 EBV 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 EBV 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 EBV.
  • Results from the Alinity m EBV WB assay should be interpreted in conjunction with other clinical laboratory findings.
  • 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 EBV WB AMP Kit is an in vitro diagnostic device which is CE-marked. Notified body number 2797.

Assay

Alinity m EBV and Alinity m EBV 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

GP350 and EBNA3

Results Units

IU/mL or Log (IU/mL)

Standardization

1st World Health Organization (WHO) International Standard for Epstein-Barr virus for Nucleic Acid Amplification Techniques (NIBSC code: 09/260)

Internal Control

Yes

External Controls

Negative, Low Positive, High Positive

Calibrators

2 calibrator levels (single-use tubes)

Plasma Sample Types (09N43-091)

Plasma K2 EDTA; K3 EDTA; Plasma Preparation Tubes (PPTs)

Plasma Input Volume (Aspirated)

500 µL

Plasma Limit of Detection (LOD)

LoD = 20 IU/mL
Probit analysis determined that the concentration of EBV DNA detected with 95% probability was 14.29 IU/mL (95% CI: 11.81, 18.22 IU/mL)

Plasma Linear Range

1.00 Log IU/mL to 8.60 Log IU/mL

Plasma Precision

≤ 0.26 Log IU/mL Total SD

Whole blood Sample Types (09N43-092)

Whole blood K2 EDTA; K3 EDT

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 8.30 Log IU/mL

Whole blood Precision

< 0.25 Log IU/mL from 3.00 to 8.30 Log IU/mL; < 0.50 Log IU/mL from 2.00 Log IU/mL to < 3.00 Log IU/mL
1. Alinity m EBV AMP Kit Package Insert: 53-608350/R3. 2. 1. Alinity m EBV WB AMP Kit Package Insert: 53-608436/R3.  3. Abbott Data on File. 4. Alinity m Operations Manual: 54-605001/R13.

ALINITY M EBV

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ALINITY M EBV WB (WHOLE BLOOD)

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Alinity m Instruments

Alinity m is a fully integrated and automated molecular diagnostics analyzer that uses ReadiFlex technology to deliver the next level of flexibility and efficiency to your lab. 

- FLEXIBILITY: True random access to perform any test, any time
- TURNAROUND TIME: <~115 minutes time to first result
- THROUGHPUT: 300 samples in ~8 hours

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