ADENOSINE DEAMINASE

INTENDED USE REAGENT COMPOSITION

Adenosine Deaminase (ADA) Assay Kit is for determination of CALIBRATION
Reagent 1 Calibration with ADA calibrator is recommended Code No.131934.
ADA activity in Serum, Plasma, Pleural fluid and Cerebrospinal
Tris HCl, pH 8.0 50 mM Calibration frequency: it is recommended to do a calibration
fluid samples.
4-AA 2 mM • after reagent lot change
PNP 0.1 U/mL • as required by internal quality control procedures
CLINICAL SIGNIFICANCE XOD 0.2 U/mL
Peroxidase 0.6 U/mL EXPECTED VALUES
ADA is an enzyme catalyzing the deamination reaction from ad-
Stabilizers For Serum, Plasma, Pleural, Pericardial and Ascetic fluids
enosine to inosine. The enzyme is widely distributed in human
Reagent 2 Normal Less than 43 U/L
tissues, especially high in T lymphocytes. Published literature
Tris-HCl, pH 4.0 50 mM Suspect for MTB 43 U/L to 62 U/L
states that elevated serum ADA activity has been observed in
Adenosine 10 mM Strong suspect for MTB Greater than 62 U/L
patients with acute hepatitis, alcoholic hepatic fibrosis, chronic
EHSPT 2 mM CSF
active hepatitis, liver cirrhosis, viral hepatitis and hepatoma In-
Normal Less than 11 U/L
creased ADA activity was also observed in patients with tuberc- REAGENT PREPARATION Suspect for TBM 11 U/L to 12.35 U/L
ulous effusions. These reports state that determination of ADA Reagents supplied are ready for use. Strong suspect for TBM Greater than 12.35 U/L
activity in patient serum may add unique values to the diagno- Calibrator (131934) and Control (131936) are sold separately.
(Tuberculous Meningitis)
sis of liver diseases in combination with ALT or -GT (GGT) te-
sts and may also be useful in the diagnosis of tuberculous pl- STABILITY AND STORAGE
euritis. The unopened reagent is stable until the expiry date stated on the The reference values are only indicative in nature. Every laboratry
label when stored at 2-8°C. should establish its own normal ranges.
On board stability: min.30 days if refrigerated (2-8°C) and not contami-
METHODOLOGY CALCULATION
nated.
The Assay is based on the enzymatic deamination of adenosi- The XL Results are calculated automatically by the instrument.
Indications of Reagent Deterioration
ne to inosine which is converted to hypoxanthine by purine nuc-
leoside phosphorylase (PNP). Hypoxanthine is then converted to
. Turbidity. QUALITY CONTROL
For quality control, ADA control Level-1 (131936) is recommended.
uric acid and hydrogen peroxide (H2O2) by xanthine oxidase . Failure to recover control values within the assigned range.
PERFORMANCE DATA
(XOD). H2O2 is further reacted with N-Ethyl-N-(2-hydroxy-3-sulf-
SPECIMEN COLLECTION & HANDLING Data contained within this section is representative of performance
opropyl)-3-methylaniline (EHSPT) and 4-aminoantipyrine (4-AA)
Serum, heparinized plasma, pleural fluid, or cerebrospinal fluid on ERBA XL systems. Data obtained in your laboratory may differ
in the presence of peroxidase (POD) to generate quinone dye from these values.
which is monitored at 546nm. The entire enzymatic reaction sc- may be assayed. Ideally, venous blood should be collected and
handled anaerobically. Do not use citrate or oxalate as
Linearty: 200 U/I
heme is shown below. Measuring range: 0 - 200 U/I
anticoagulant.
ADA
Plasma and serum, after prompt separation from cells or clot,
PRECISION
Adenosine + H2O Inosine + NH3
should be kept tightly stoppered. ADA content of blood is stable Intra-assay precision Mean
PNP SD (U/L) CV (%)
Inosine + Pi Hypoxanthine + Ribose-1-phosphate for 1 week when stored at 2-8°C. Pleural fluid should be collected Within run (n=20) (U/L)
XOD in a sterile or heparinized tube and processed within 2 hours at Sample 1 11.11 0.16 1.47
Hypoxanthine + 2H2O + 2O2 Uric acid + 2H2O2 room temperature or stored at 2-8°C or -20°C for 2 days and up to
2.5 years at -80°C. Cerebrospinal fluid (CSF) should be clear and Sample 2 30.74 0.45 1.45
POD
2H2O2 + 4-AA + EHSPT 4H2O + Quinone dye
(wave length max 546nm) collected in a sterile tube without anticoagulant. ADA is stable in Inter-assay precision Mean
CSF for 24 hours at 25ºC, 7 days at 2-8ºC and 3 months at -20ºC.
SD (U/L) CV (%)
Run to run (n=20) (U/L)
One unit of ADA is defined as the amount of ADA that generates ASSAY PROCEDURE Sample 1 9.63 0.47 4.9
one µ mole of inosine from adenosine per min at 37°C. Refer to the assay parameters for details. Sample 2 29.62 0.59 2.0
 ASSAY PARAMETERS
X L -10 0 X L -2 00 X L -30 0/6 0 0 X L- 640 X L - 10 0 0 X L -1 8 0
INTERFERENCE I n stru m e n t
EM -1 0 0 EM -2 00 E M -36 0

Following substances do not interfere: T e st D e ta i ls

Te s t ADA A DA A DA A DA ADA A DA
bilirubin up to 30 mg/dL, haemoglobin up to 200 mg/
Te s t C od e 77 77 77 77 77 77
dL, triglycerides up to 750 mg/dL, and ascorbic acid A de n os in e A de no s ine A d e no s ine A d en os in e A de n os in e A de no s ine
R ep ort N a m e
up to 4mg/dL. de a m ina s e de am ina s e d e am in as e d ea m in as e de a m ina s e de am ina s e
U nit IU / L IU /L IU /L IU /L IU / L IU /L
D ec im al P lac es 1 1 1 1 1 1
XL-100 XL -200 XL-300/600 XL- 640 XL- 1000 XL-180
WARNING AND PRECAUTIONS W ave le ng th -P rim a ry 54 6 546 5 46 54 6 54 6 546 Instrument
EM-100 EM-200 EM-360
For in vitro diagnostic use. To be handled by entitled and W ave le ng th -S e c o nd a ry 0 0 0 0 0 0
Reference Ranges
A s s ay ty pe R ate -A R a te -A R a te-A R at e-A R ate -A R a te -A
professionally educated person. C urve ty pe L in ea r Line a r Line ar L in ea r L in ea r Line a r Test ADA ADA ADA ADA ADA ADA
Reagents of the kit are not classified as dangerous but M 1 S ta rt 0 0 0 0 0 0 Sample Type SERUM SERUM SERUM SERUM SERUM SERUM
contain less than 0.1% sodium azide - classified as very M 1 E nd 0 0 0 0 0 0 Reference Range Default Default Default Default Default Default
M 2 S ta rt 24 24 25 38 22 24
toxic and dangerous substance for the environment. Category Male
M 2 E nd 34 34 43 58 31 34
Normal-Lower Limit 0 0 0 0 0 0
S am ple rep lic a te s 1 1 1 1 1 1
S tan da rd re plic ate s 3 3 3 3 3 3 Normal-Upper Limit 43 43 43 43 43 43
WASTE MANAGEMENT
C on tro l re p lic a tes 1 1 1 1 1 1 Panic-Lower Limit NA NA NA NA NA NA
As per local legal requirements. C on tro l inte rva l 0 0 0 0 0 0 Panic-Upper Limit NA NA NA NA NA NA
R ea c tion D ire c tion Inc re as in g Inc re as in g In c rea s ing In c rea s ing Inc re as in g Inc re as in g
Category Female
REFERENCES R ea c t. A b s . Lim it NA NA NA NA NA NA
Normal-Lower Limit 0 0 0 0 0 0
P roz on e Lim it % 0 0 0 0 0 0
1. Kobayashi F, Ikeda T, Marumo F, Sato C: Normal-Upper Limit 43 43 43 43 43 43
P roz on e C h ec k Lo w e r Lo w er L ow er L ow e r Lo w e r Lo w er
Adenosine deaminase isoenzymes in liver L in e arity Lim it % 0 0 0 0 0 0 Panic-Lower Limit NA NA NA NA NA NA
disease. Am. J. Gastroenterol. 88: 266-271 (1993) D elta A bs /M in NA NA NA NA NA NA
Panic-Upper Limit NA NA NA NA NA NA
2. Kallkan A., Bult V., Erel O., Avci S., and Bingol N. Te c h nic a l M inim u m 0 0 0 0 0 0
Revision Number
Te c h nic a l M a x im u m 20 0 200 2 00 20 0 20 0 200
K.: Adenosine deaminase and guanosine Revision <A-100-ADA- <A-200-ADA- <A-300/600- <A-640-ADA- <A-1000- <A-180-ADA-
Y= a X + b
deaminase activities in sera of patients with viral a= 1 1 1 1 1 1
2 2 ADA-2 2 ADA-2 2
10.04.2017> 10.04.2017> 10.04.2017> 10.04.2017> 10.04.2017> 10.04.2017>
hepatitis. Mem Inst. Oswaldo Cruz 94(3) 383-386 b= 0 0 0 0 0 0
(1999) R ea ge nt A b s M in 0 0 0 0 0 0 SYMBOLS:
3. Burgess LJ, Maritz FJ, Le Roux I, et al. Use of R ea ge nt A b s M a x 2 .5 2 .5 2.5 2 .5 2 .5 2 .5 The following symbols are used in the labelling of ERBA
adenosine deaminase as a diagnostic tool for
A uto R e ru n No No No No No No Mannheim kits:
To tal R e ag en ts 2 2 2 2 2 2
tuberculous pleurisy. Thorax 50: 672-674 (1995) R ea ge nt R 1 A D A R1 A DA R1 A DA R 1 A DA R1 A D A R1 A DA R1

4. Lakkana B., Sasisopin K: Use of Adenosine R ea ge nt R 2 A D A R2 A DA R2 A DA R 2 A DA R2 A D A R2 A DA R2

Deaminase for the Diag-nosis of Tuberculosis: A R ea ge nt R 3 NA NA NA NA NA NA

T e st V o lum e s
review J. Infect. Dis Antimicrob Agents 2010;
Tes t ADA A DA A DA A DA ADA A DA
27:111-8 S am ple Ty pe S E RUM S E R UM S E RUM S E RUM S E RUM S E R UM
5. Delacour H., Sauvanet C., Ceppa F., Burnat P.: S a m ple V olu m e s

Analytical perfor-mances of the Diazyme ADA N orm al 5 5 5 5 3.5 5

D ilution Ratio 1 1 1 1 1 1
assay on the Cobas 6000 system. Clinical
Inc reas e 10 10 10 10 7 10
Biochemistry 43 (2010) 1468-1471.
D ilution Ratio 1 1 1 1 1 1

PACK PRESENTATION
D ec reas e 2.5 2.5 2.5 2.5 2 2.5 ADA
D ilution Ratio 1 1 1 1 1 1
CODE NO.: 131933 ( R1 : 1x20 ml / R2 : 1x10 ml )
S tandard volum e 5 5 5 5 3.5 5
Revision No.: 3-310318 ADA R e a g e nt V ol um e s a n d S tirre r spe e d
R G T-1 V olum e 180 180 180 180 120 180
R 1 S tirrer S peed M edium M edium NA M edium M edium M edium
Transasia Bio-Medicals Ltd.
R G T-2 V olum e 90 90 90 90 60 90
Nalagarh Road, Village Malpur, R 2 S tirrer S peed High High NA High High High
Baddi, Dist.Solan, (HP) - 173205 R G T-3 V olum e 0 0 0 0 0 0
R 3 S tirrer S peed NA NA NA NA NA NA