BD Macro-Vue Bedienungsanleitung

Macro-Vue™ RPR Card Tests
B
18 mm Circle Qualitative and Quantitative
Brewer Diagnostic Kit for the Serologic Detection of Syphilis
English: pages 1 – 3
Français : pages 3 – 5
Deutsch: Seiten 5 – 7
Contact your local BD representative for instructions. / Свържете се с местния представител на BD за инструкзии. / Pokyny vám
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/ Naudojimo instrukcijų teiraukitės vietos BD įgaliotojo atstovo. / Neem contact op met uw plaatselijke BD-vertegenwoordiger voor
instructies. / Kontakt din lokale BD-representant for mer informasjon. / Aby uzyskać instrukcje użytkowania, skontaktuj się z lokalnym
przedstawicielstwem BD. / Contacte o representante local da BD para instruções. / Pentru instrucţiuni, contactaţi reprezentantul local BD.
/ Для получения указаний обратитесь к местному представителю компании BD. / Inštrukcie získate u miestneho zástupcu spoločnosti
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Talimatlar için yerel BD temsilcinizle temasa geçin. / За інструкціями зверніться до місцевого представника компанії BD.
INTENDED USE
The Macro-Vue RPR (Rapid Plasma Reagin) 18 mm Circle Card Test is a nontreponemal testing procedure for the serologic detection of
™
syphilis. 1,2
SUMMARY AND EXPLANATION
The Macro-Vue RPR Teardrop Card Test (using finger puncture blood) was the original Card Test and was developed for field use where testing
could be performed without laboratory equipment.
the RPR Circle Card Test was developed for use in large scale testing in public health and clinical laboratories.
The RPR 18 mm Circle Card Test is recommended when venous blood collection is employed and a large volume of serum is available, such as
generally prevails in public health and clinical laboratories.
the carbon particles of the RPR Card antigen, which appear as black clumps against the white background of the plastic-coated card. By contrast,
nonreactive specimens appear to have an even light-gray color.
In special situations when nontreponemal test results are needed rapidly and the specimen is collected as EDTA plasma, the RPR
18 mm Circle Card Test can be used if the test is performed within 24 h.
PRINCIPLES OF THE PROCEDURE
RPR Card antigen suspension is a carbon particle cardiolipin antigen
from syphilitic persons, and occasionally in serum or plasma of persons with other acute or chronic conditions. The reagin binds to the test antigen,
which consists of cardiolipin-lecithin-coated cholesterol particles, causing macroscopic flocculation.
REAGENT
The ingredients* of the RPR Card antigen suspension are
0.01 M Na HPO , 0.01 M KH
2 4
deionized/distilled water.
*Adjusted and/or supplemented as required to meet performance criteria.
Warnings and Precautions:
For in vitro Diagnostic Use.
Pathogenic microorganisms, including hepatitus viruses and Human Immunodeficiency Virus, may be present in clinical specimens. "Standard
Precautions" 15-18 and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids.
Warning
H302 Harmful if swallowed. H315 Causes skin irritation. H319 Causes serious eye irritation. P101 If medical advice is needed, have product
container or label at hand. P280 Wear protective gloves/protective clothing/eye protection/face protection. P264 Wash thoroughly after handling.
P301+P312 IF SWALLOWED: Call a POISON CENTER or doctor/physician if you feel unwell. P501 Dispose of contents/container in accordance
with local/regional/national/international regulations.
Antigen: Refrigeration is recommended for the RPR Card antigen suspension only. Storage in bright sunlight or temperatures above 30 °C should
be avoided; such conditions may cause a rough appearance of the antigen when used with nonreactive sera. If the ampule of antigen is frozen
during shipment, it can be reconstituted once by warming to room temperature; avoid repeated freezing and thawing. Immediate use of a refrigerated
antigen may result in decreased sensitivity of the test. Therefore, upon removal from the refrigerator, allow the antigen to warm to room temperature
(23 to 29 °C) before use.
Do not use antigen beyond the expiration date.
Diagnostic Test Cards: Specially prepared, plastic-coated cards designed for use with the RPR Card antigen. In handling, take care not to
fingermark the card test areas, as this may result in an oily deposit and improper test results. When spreading specimen within confines of test
areas, avoid scratching the card with the Dispenstirs™ device. If the specimen does not spread to the outer perimeter of test area, use another
test area of card.
Dispenstirs™ and Capillaries: In performing the Card Tests, a Dispenstirs device (18 mm Circle qualitative test only) or capillary may be used
to transfer the specimen to the card surface. A new Dispenstirs device or capillary must be used for each test specimen. When transferring from
the collecting tube, the specimen must not be drawn up into the rubber bulb attached to the capillary, as this will cause incorrect readings on
subsequent tests.
Needles: To maintain clear passage for accurate drop delivery, upon completion of the tests, remove the needle from the dispensing bottle and
rinse the needle with deionized/distilled water. Do not wipe the needle since this will remove the silicone coating and may affect the accuracy of
the drop of antigen being dispensed.
Reading of Card Test Results: Read immediately following rotation in the "wet" state under a high intensity incandescent lamp or strong daylight.
Rotation: The recommended speed for mechanical rotation is 100 ± 2 rpm. The rotator should circumscribe a circle approximately two centimeters in
diameter in the horizontal plane. A moistened humidifying cover should be used to prevent drying of test specimens during rotation.
Storage of Antigen: Refrigerate at 2 to 8 °C. All other components of the kit should be stored in a dry place at room temperature in the original
packaging. See "Warnings and Precautions" for additional information.
Once placed in the dispensing bottle (provided in each kit) and refrigerated (2 to 8 °C), the antigen reactivity remains satisfactory for approximately
three months, or until the expiration date, if it occurs sooner.
Label the dispensing bottle with the antigen lot number, expiration date, and date antigen was placed in the bottle.
SPECIMEN COLLECTION AND PREPARATION
No special preparation of the patient is required prior to specimen collection.
To Test Unheated Serum: Collect blood by venipuncture into a clean, dry tube without anticoagulant and allow to clot.
Centrifuge the specimen at a force sufficient to sediment cellular elements. Keep the serum in the original collecting tube
or transfer the serum into a clean, dry test tube if testing is to be delayed. Serum, removed from the clot, may be refrigerated at
2 to 8 °C, for up to 5 days or frozen at -20 °C or below in a Pyrex (or equivalent) vial or capped test tube.
To Test Heated Serum: After collection and centrifugation, as for unheated serum, transfer to a clean dry tube and place in 56 °C water bath, or
a heat block for 30 min.
To Test Unheated Plasma: Collect blood by venipuncture into a tube containing anticoagulant such as EDTA, heparin, potassium oxalate,
potassium sequestrene or sodium fluoride. EDTA and heparin have the advantage of not being critical with respect to concentration; as little as 1
mL of blood in a tube normally used to collect 7 mL of blood produces satisfactory results. With the other anticoagulants, it is advisable to collect no
less than one half a tube of blood. Centrifuge as above. Keep plasma in the original collecting tube, and if stored, store the specimen at 2 to 8 °C.
Test specimen within 24 h of blood collection.
PROCEDURES AND RESULTS
Materials Provided: Various RPR Card Test kits are available (see "Availability") which contain sufficient card antigen suspension, with a pre-
installed ampule opener, to perform the specified number of daily control card and card tests, and the required dispensing bottle, dispensing needle,
cards and either capillaries, or Dispenstirs devices.
Materials Required But Not Provided:
1. Controls with established patterns of graded reactivity should be included in each day's testing to confirm optimal reactivity of the antigen. See
"Availability" for Macro-Vue RPR 18 mm Circle Card Test Control Cards.
2. A rotator, 100 ± 2 rpm, circumscribing a circle 2 cm in diameter, with automatic timer, friction drive, and a cover containing a moistened sponge
or blotter.
3. Saline (0.9%) for use in quantitative testing. Prepare by adding 900 mg dry sodium chloride, ACS to 100 mL deionized/distilled water.
4. Serum Nonreactive to syphilis in 0.9% saline; required for diluting test specimens giving a Reactive result at the 1:16 dilution.
Also required is the necessary equipment and labware used in preparation, storage and handling of serologic specimens.
Preliminary Preparations: Review "Warnings and Precautions" and "Specimen Collection and Preparation" prior to performance of card tests.
When tests are to be performed, the antigen suspension should be checked with controls of graded reactivity using the particular test procedure.
Only those antigens which give the prescribed reactions should be used. Controls, RPR Card antigen suspension and test specimens should be
at room temperature when used.
Before use, vigorously shake the ampule for 10 to 15 s to resuspend the antigen and disperse any carbon particles lodged in the neck of the ampule.
If any carbon should remain in the neck of the ampule after this shaking, no additional effort should be made to dislodge it as this will only tend to
produce a coarse antigen.
Check delivery of the needle by placing the needle firmly on a 1 mL
pipet or syringe; fill the pipet or syringe with antigen suspension, and
holding the pipet or syringe in a vertical position, count the number
of drops delivered in 0.5 mL. The correct number of drops is given
in the table opposite:
Attach the needle to the tapered fitting on the dispensing bottle. Be sure the antigen is below the breakline; snap the ampule neck using the
pre-installed opener and withdraw all of the antigen into the dispensing bottle by collapsing the bottle and using it as a suction device. Label the
dispensing bottle with the antigen lot number, expiration date, and date antigen was placed in the bottle. Shake the antigen dispensing bottle gently
before each series of antigen droppings.
The needle and dispensing bottle should be discarded when the kit is used up.
It is imperative techniques as described herein be followed in detail.
18 mm Qualitative Card Test Using Dispenstirs
1. Hold a Dispenstirs device between thumb and forefinger near the stirring or sealed end. Squeeze and do not release pressure until open end
is below surface of specimen, holding the specimen tube vertically to minimize stirring up of cellular elements when using original blood tube.
Release finger pressure to draw up the sample.
2. Holding in a vertical position directly over the card test area to which the specimen is to be delivered (not touching card sur face), squeeze
Dispenstirs device allowing one drop to fall onto card (approx. 0.05 mL; each Dispenstirs device is designed to expel slightly in excess of
0.05 mL to compensate for small amount of specimen retained by stirring end).
3. Invert Dispenstirs device and with sealed stirring end, spread the specimen filling entire surface of circle. (If desired, sample remaining may be
discharged into specimen tube from which it was drawn.) Discard Dispenstirs device. Repeat procedure for number of specimens to be tested.
4. Gently shake antigen dispensing bottle before use. Holding in a vertical position, dispense several drops in dispensing bottle cap to make sure the
needle passage is clear. Place one "free-falling" drop (20 G, yellow hub needle) onto each test area. Do not restir; mixing of antigen and specimen
is accomplished during rotation. Pick up the pre-dropped antigen from bottle cap.
5. Rotate for 8 min (± 30 s) under humidifying cover, on mechanical rotator at 100 ± 2 rpm.
Following rotation, to help differentiate Nonreactive from Minimally Reactive results, a brief rotating and tilting of the card by hand (3 or 4 to-and-fro
motions) must be made. Immediately read macroscopically in the "wet" state under a high intensity incandescent lamp or strong daylight.
Report as: Reactive — Showing characteristic clumping ranging from slight but definite (minimal-to-moderate) to marked and intense.
Nonreactive — Showing no clumping. See the Reading Guide.
Note: There are only two possible final reports with the Card Test — Reactive or Nonreactive, regardless of the degree of reactivity. Reactivity
minimal-to-moderate (showing slight, but definite clumping) is always reported as Reactive.
Italiano: pagine
Portugués: páginas
Español: páginas 12 – 14
3,4 By incorporating machine rotation, ringed test surfaces, and certain other technical changes,
PO , 0.2% sodium azide (preservative), 0.02% charcoal (specially prepared, BD), 10% choline chloride, w/v, and
2 4
Devices :
™
7 – 9
9 – 11
5-12 When a specimen contains antibody, flocculation occurs with a coagglutination of
13,14
1 which detects "reagin", an antibody-like substance present in serum or plasma
1 : 0.003% cardiolipin, 0.020 – 0.022% lecithin, 0.09% cholesterol, 0.0125 M EDTA,
Test Method
18 mm Circle

1 Avoid repeated freeze–thawing of specimens.
Number of Drops
Color of Needle Hub
Yellow, 20 G
0212013JAA(03)
2015-07
in 0.5 mL
30 ± 1 drop