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ADA export use

The Adenosine Deaminase (ADA) Assay is designed for measuring ADA activity in various bodily fluids and is noted for its cost-effectiveness and accuracy compared to the IFN-y assay, especially in resource-limited settings. The Diazyme ADA assay offers advantages such as minimal ammonia interference, rapid results, and a liquid stable format that requires no reagent preparation. It is regulated for export only and not available for distribution in the USA.

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0% found this document useful (0 votes)
8 views2 pages

ADA export use

The Adenosine Deaminase (ADA) Assay is designed for measuring ADA activity in various bodily fluids and is noted for its cost-effectiveness and accuracy compared to the IFN-y assay, especially in resource-limited settings. The Diazyme ADA assay offers advantages such as minimal ammonia interference, rapid results, and a liquid stable format that requires no reagent preparation. It is regulated for export only and not available for distribution in the USA.

Uploaded by

Sinari Alfat
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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DZ117A

ADENOSINE DEAMINASE
(ADA) ASSAY
Liver
Marker

Adenosine Deaminase (ADA) Assay is for determination of ADA activity in serum,


plasma, pleural fluid, and cerebrospinal fluid samples.
Diazyme’s Adenosine Deaminase (ADA) assay is a cost effect liquid stable test
system that can be run either manually or on open automated chemistry systems.
Recent reports state that the accuracy of the ADA assay was similar to that of the
IFN-y assay in differentiating TB from non-TB ascites. Because both material and
human costs of the ADA assay are far less than those of the IFN-y assay, the former
is probably the most appropriate diagnostic test for analysis of peritoneal fluid in
resource-limited settings. 1

DIAZYME ADA ASSAY ADVANTAGES


• Diazyme’s ADA assay has been found to show virtually no ammonia interference.2
• Multiple published studies in major journals worldwide have highlighted the excellent
accuracy, precision and reliability of the Diazyme enzymatic Non-Giusti method in serum,
heparinized plasma, plural effusion, pericardial effusion and CSF fluids.3-6
• Fast test results (10 minutes) for a rapid turnaround time
• Liquid stable format requires no reagent preparation
• Wide range of instrument parameters available for simplifying implementation

REGULATORY STATUS
EU:
SKU For Export Only. Not for Distribution in the USA.

Innovations in Clinical Diagnostics


ADENOSINE DEAMINASE
(ADA) ASSAY Dual Vial
Liquid Stable

ASSAY SPECIFICATIONS ASSAY PRECISION


The precision of the Diazyme Adenosine Deaminase Assay
Enzymatic
Method was evaluated on the Cobas Mira instrument according to
(Colorimetric / Kinetic) a modified Clinical Laboratory Standards Institute EP5-A
• Serum guideline. In the study, two serum specimens containing 11
Sample • Plasma U/L and 30 U/L ADA were tested with 2 runs per day with
Type & - Li-heparin duplicates over 15 working days.
Volume
Sample Volume 5 μL
N = 15 Within Run Precision Run To Run Precision

Method y-intercept = -0.4219


11 U/L 30 U/L 11 U/L 30 U/L
Comparison Slope = 1.0688
R2 = 0.9894 No. of Data
30 30 30 30
Linearity 0 to 200 U/L Points

LOD 0.0333 U/L Mean (U/L) 11.11 30.74 9.63 29.62

Calibration SD (U/L) 0.16 0.45 0.47 0.59


1-Point Calibration
Levels CV (%) 1.47 1.45 4.90 2.00
Reagent Opened:
On-Board Four weeks when
Stability stored at 2-8°C
ADA Assay Procedure* ASSAY INTERFERENCE
The common serum interfering substances showed less than
10% interference up to the concentrations summarized below.

Serum Bilirubin: up to 30 mg/dL


0 550 nm 3 min8 min 11 min
Hemoglobin: up to 200 mg/dL
*Analyzer Dependent
Triglycerides: up to 750 mg/dL
Parameter questions for ADA Assay should be
Ascorbic acid: up to 4 mg/dL
addressed to Diazyme technical support. Please
call 858.455.4768 or email [email protected]

1. Sharma, S.k., Mohammad Tahir, Alladi Mohan, Duncan Smith-Rohrberg,


Hemant K. Mishra, and R.m. Pandey. “Diagnostic Accuracy of Ascitic
Fluid IFN-γ and Adenosine Deaminase Assays in the Diagnosis of
Tuberculous Ascites.” Journal of Interferon & Cytokine Research 26.7
(2006): 484-88. Web.
2. Delacour, Hervé, Aurore Bousquet, Eléonore Fontan, and Franck Ceppa.
“Ammonia Does Not Interfere with the Diazyme Adenosine Deaminase
Test.” Clinical Chemistry and Laboratory Medicine 51.10 (2013): n. pag.
Web.
3. Feres, M. C., M. C. Martino, S. Maldjian, F. Batista, A. Gabriel, andS. Tufik.
DIAZYME LABORATORIES, INC.
“Automatized Adenosine Deaminase Activity Determination in Pleural 12889 Gregg Court, Poway, CA 92064 USA
Fluid and Cerebral Spinal Fluid.” OASIS - Online Abstract Submission and PO Box 85608, San Diego, CA 92186 USA
Invitation System. Coe-Truman Technologies, Inc., 24 July 2008. Web. 13
June 2016. Tel: +1-858-455-4768 +1-888-DIAZYME
4. Delacour, Hervé, Christophe Sauvanet, Franck Ceppa, and Pascal Burnat. www.diazyme.com [email protected]
“Analytical Performances of the Diazyme ADA Assay on the Cobas® 6000
System.” Clinical Biochemistry 43.18 (2010): 1468-471. Web. DIAZYME EUROPE GMBH
5. Song, David; Lun, Andrea R and Chiu, Weldon. Diazyme Adenosine Zum Windkanal 21, 01109 Dresden, Germany
Deaminase in the Diagnosis of Tuberculous Pleural Effusion: Method
Tel: +49-351-886-3300 Fax: +49-351-886-3366
Evaluation and Clinical Experiences in a New Zealand Population
[online]. New Zealand Journal of Medical Laboratory Science, Vol. 64, [email protected]
No. 1, Apr 2010: 11-13. Availability: <http://search.informit.com.au/
documentSummary;dn=232037372692385;res=IELHEA> ISSN: 1171- DIAZYME SHANGHAI CO., LTD.
0195. [cited 14 Jun 16].
Room 201,1011 Halei Road, Zhangjiang Hi-tech Park
6. Morisson, Patrizio, & Neves, Denise Duprat. (2008). Evaluation of
adenosine deaminase in the diagnosis of pleural tuberculosis: a Brazilian Shanghai, 201203, People’s Republic of China
meta-analysis. Jornal Brasileiro de Pneumologia, 34(4), 217-224. Tel: +86-21-51320668 Fax: +86-21-51320663
https://dx.doi.org/10.1590/S1806-37132008000400006.
www.lanyuanbio.com [email protected]

DZ014 (10/2019) MK055 Rev. 12

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