Enviado por Do utilizador5122

RF Turbilatex

Propaganda
RF TURBILATEX
INTENDED USE:
The reagent kit is intended for the” invitro” quantitative determination of
Rheumatoid factor in human serum.
PROCEDURE:
CLINICAL SIGNIFICANCE:
Calibration Curve : (Range from 20 to 160 IU/ml) Prepare the
following RF calibrator dilutions in normal saline. Multiply the
concentration of the RF-calibrator by the corresponding factor stated in
table bellow to obtain the RF concentration of each dilution.
Rheumatoid factors are a group of antibodies directed to determinants in
the Fc portion of the immunoglobulin G molecule. Although rheumatoid
factors are found in a number of rheumatoid disorders, such as systemic
lupus erythematosus (SLE) and Siogren's syndrome as well as in nonrheumatic conditions, its central role in clinic lies in its utility as an aid in the
diagnosis of Rheumatoid Arthritis (RA)
.A study of the "American College of Rheumatology" show that the 80.4%
of RA patient were RF positive.
PRINCIPLE:
The RF - Turbilatex is a quantitative turbidimetric test for the measurement
of RF in human serum or Plasma.Latex particles coated with human
gamma globulin are agglutinated w hen mixed with samples containing
RF. The agglutination causes an absorbance change, dependent upon
the RF contents of sample that can be quantified by comparison from
calibrator of a known RF concentration.
CONTENTS:
Reagent 1 : Diluent
Reagent 2 : Latex Antigen
Reagent 3 : RF Calibrator
Calibrator dilution 1
Calibrator RF (µl) Normal Saline
100
Factor
0
2
10
90
0.1
3
25
75
0.25
4
50
50
0.5
5
75
25
0.75
6
100
1.0
One point calibration : (Linear range up to 100 IU/ml)
Prepare RF calibrator dilution : 30 µl RFcalibrator + 70 µl normal
saline. Multiply the RF calibrator concentration by 0.30 to
obtain the RF concentration of the diluted calibrator.
CALCULATION OF RESULTS:
Calibration curve (Note 1) : Calculate the absorbance difference
(A2-Ablankreagent) of each point of the calibration curve and plot the value
obtained against the RF concentration of each calibrator dilution.
Rheumatoid factorconcentration in the sample is calculated by interpolation
of its (A2-A blank reagent )in the calibration curve.
One Point Calibration
MATERIALS REQUIRED BUT NOT PROVIDED:
- Clean & Dry Glassware.
- Laboratory Glass Pipettes or Micropipettes & Tips.
- Bio-Chemistry Analyzer.
(A2-A blank reagent
Sample )
RF IU/mL. =
X Diluted Calibrator concentration
(A2-A blank reagent
calibrator )
PROCEDURE :
SAMPLES:
Reagent
Blank
Calibrator
Sample
Fresh serum stable for 7 days at 2 -8°C or 3 months at -20° C. Samples
with presence of fibrin should be centrifuged before testing. Do not use
highly hemolyzed or lipemic samples.
Working Reagent
1.0 ml
1.0 ml
1.0 ml
PREPARATION OF WORKING REAGENT
Working Reagent : Swirl the latex vial gently before use Prepare
the necessary amount as follow :
1 ml latex reagent + 9 ml Diluent.
RF Calibrator
: Reconstitute with 2.0 ml of Distilled water. Mix
gently and keep at room temperature for 10 minutes before use.
7 µl
-
7 µl
-
7 µl
Mix and read the absorbance after 2 min of the sample addition.
For multipoint calibrator use all the 6 calibrators stated as here above.
For single point calibration use diluted calibrator as shown here above
NORMAL VALUE:
Up to 20 IU/ml
Each laboratory should establish its own reference range.
STORAGE & STABILITY:.
Working Reagent : Stable for 30 days at 2 -8° C
RF Calibrator
Normal Saline
Calibrator *
Sample
: Stable for 1 month at 2-8°C or 3 months at -20°C.
Do not freeze; frozen latex or diluent could change the functionality of the
test.
GENERAL SYSTEM PARAMETERS:
Reaction Type
Wavelength
: End point / Multi Standard
: 650 nm (600-650 nm)
Cuvette Temperature
Calibrator Concentration
Incubation
Sample Volume
Reagent Volume
Zero Setting
Blank
Light Path
Calibrator concentration
: 37 C
: Dilution Factor x Calibrator Concentration
: 2 min.
: 7 µl
: 1 ml
: Deionised Water
: Reagent blank
: 1 cm.
: 153 IU/ml
0
LINEARITY:
The reaction is linear up to 160 IU/ml.
PAERFORMANCE CHARACTERISTS:
1. Linearity Limit : Up to 160 IU/ml by multi-standard & 100 IU/ml by one
point calibration.
2. Detection Limit : Values less than 6 IU/ml give non-reproducible results.
3. Prozone Effect : No prozone effect was detected up to 800 IU/ml.
QUALITY CONTROL:
It is recommended that each laboratory should prepare their own quality
control scheme.
LIMITATIONS AND PRECAUTIONS:
- Storage conditions mentioned on the kit to be adhered.
- Bilirubin (20mg/dl) Haemoglobin (10 g/L), Lipemia (10 g/L)do not terfere.
Other substances may interfere.
REFERENCES:
1. Frederick Wolfe et al. Arthritis and Rheumatism 1991; 34: 951-960.
2. Robert W Dorner et al. Clinica Chimica Acta 1987; 167: 1-21.
3. Robert H Shmerling et al. The American Journal of Medicine 1991; 91: 528534.
IVD
CODE NO. PACK SIZE
T03
50 ML
EC REP
UNIONPROJET S.R.L.S.
Via Aliprandi 41-20851
Lissone (MB)
www.jas-anz.com.au/register
ISO 9001:2015
ISO 13485:2003
Download
Random flashcards
modelos atômicos

4 Cartões gabyagdasilva

A Jornada do Herói

6 Cartões filipe.donner

Estudo Duda✨

5 Cartões oauth2_google_f1dd3b00-71ac-4806-b90b-c8cd7d861ecc

Criar flashcards