neutral formalin - Thermo Fisher Scientific

PRODUCT DETERIORATION
This product should not be used if (1) the appearance has changed
from clear and colorless, (2) the expiration date has passed, or
(3) there are other signs of deterioration.
NEUTRAL FORMALIN
INTENDED USE
Remel Neutral Formalin is a liquid medium recommended for use in
qualitative procedures for transportation, preservation, and examination of stool specimens for intestinal parasites. Preserved
specimens are used in concentration procedures to recover helminth
larvae and eggs, and protozoan cysts.
SUMMARY AND EXPLANATION
The diagnosis of intestinal parasitic infections is confirmed by
recovery and identification of helminth larvae and eggs, and
protozoan cysts. Feces and other body materials that cannot be
examined soon after passage must be placed in a preservative, such
as formalin, to maintain the structural integrity of larvae, eggs, and
1
cysts during transport.
PRINCIPLE
Two concentrations are commonly used: 5% is recommended for
preservation of protozoan cysts and 10% for helminth eggs and
larvae. Neutral (buffered) formalin is preferred over unbuffered
formalin, especially for long-term preservation of reference
specimens. Sodium phosphate buffers help maintain organism
2
morphology.
REAGENTS (CLASSICAL FORMULA)*
Neutral Formalin, 10%:
Na2HP04 .....................................................................................6.10 g
NaH2P04 .....................................................................................0.15 g
Formalin, commercial formaldehyde........................................800.0 ml
Demineralized Water .............................................................7200.0 ml
Neutral Formalin, 5%:
Na2HP04 .....................................................................................6.10 g
NaH2P04 .....................................................................................0.15 g
Formalin, commercial formaldehyde........................................400.0 ml
Demineralized Water .............................................................7600.0 ml
pH 7.4 ± 0.4 @ 25C
SPECIMEN COLLECTION, STORAGE, AND TRANSPORT
Specimens should be collected and handled following recommended
3,4
guidelines.
1.
2.
3.
Substances and medications, such as mineral oil, barium,
bismuth, antibiotics, antimalarials, and nonabsorbable
antidiarrheal preparations, interfere with the detection of
intestinal protozoa. Intestinal protozoa may be undetectable for
one to several weeks after administration of any of these
substances. Specimen collection should be performed after
seven days in the case of antibiotics or barium.
Specimens should not be contaminated with water or urine.
Water may contain free-living organisms that can be mistaken
for human parasites and urine may destroy motile organisms.
A series of three specimens is considered a minimum for an
adequate examination. Stool specimens should be collected
every other day or within a time frame of no more than 10 days.
If a series of 6 specimens is ordered, they should be submitted
within a 14-day period.
MATERIALS REQUIRED BUT NOT SUPPLIED
(1) Paper towels or other absorbent material, (2) Applicator sticks,
plain and cotton-tipped, (3) Disposable glass or plastic pipettes,
(4) Fecal Concentrator Kit (R21901 or R21911) or a suitable alternative (5) Dobell & O’Connor Iodine (R21510) (6) Glass microscope
slides, coverslips (7) Microscope with a calibrated ocular micrometer.
PROCEDURE
1. Mix the fixative with the specimen in a 3 to 1 ratio. Generally,
fixation time should be no less than 30 minutes.
2. Follow established laboratory procedures for concentrating and
processing preserved specimens.
INTERPRETATION
This transport medium serves as a vehicle for preserving intestinal
parasites while transporting the specimen to the laboratory.
*Adjusted as required to meet performance standards.
PRECAUTIONS
DANGER! POISON. Warning! Contains formaldehyde which can
cause cancer. May cause allergic respiratory and skin reaction.
Causes eye, skin, and respiratory tract irritation. May be harmful if
swallowed, inhaled, or absorbed through the skin. May cause central
nervous system depression. Avoid breathing vapor and skin contact.
Wash hands thoroughly after handling. Call physician if swallowed.
Keep out of reach of children. Refer to Material Safety Data Sheet for
more information.
This product is for In Vitro diagnostic use and should be used by
properly trained individuals. Take precautions against the dangers of
microbiological hazards by properly sterilizing specimens, containers,
and media after use. Directions should be read and followed
carefully.
STORAGE
This product is ready for use and no further preparation is necessary.
Store product in its original container at room temperature until used.
QUALITY CONTROL
All lot numbers of Neutral Formalin have been tested using the
following quality control organism and have been found to be
acceptable. Testing of control organisms should be performed in
accordance with established laboratory quality control procedures. If
aberrant quality control results are noted, patient results should not
be reported.
CONTROL
Giardia intestinalis
®
ATCC 30888
INCUBATION
Ambient, 24 h @
room temperature
RESULTS
Good morphology,
intact trophozoites
LIMITATIONS
1. Results obtained will largely depend on proper and adequate
specimen collection and fixation. Adequate mixing of the
specimen and preservative is mandatory.
2. Oily materials, such as mineral oil, create refractile droplets that
make examination difficult.
BIBLIOGRAPHY
1. Melvin, D. and M. Brooke. 1982. Laboratory Procedures for the
rd
Diagnosis of Intestinal Parasites. 3 ed. U.S. Dept. of H.H.S.
and CDC, Atlanta, GA.
th
2. Garcia, L.S. 2001. Diagnostic Medical Parasitology. 4 ed. ASM
Press, Washington, D.C.
3. Versalovic, J., K.C. Carroll, G. Funke, J.H. Jorgensen, M.L.
Landry, and D.W. Warnock. 2011. Manual of Clinical
th
Microbiology. 10 ed. ASM Press, Washington, D.C.
4. Forbes, B.A., D.F. Sahm, and A.S. Weissfeld. 2007. Bailey and
th
Scott’s Diagnostic Microbiology. 12 ed. Mosby Elsevier, St.
Louis, MO
Symbol Legend
REF
Catalog Number
IVD
In Vitro Diagnostic Medical Device
LAB
For Laboratory Use
Consult Instructions for Use (IFU)
Temperature Limitation (Storage Temp.)
LOT
Batch Code (Lot Number)
Use By (Expiration Date)
PACKAGING
REF R21640, 10% Formalin, 15 ml/Vial ............................. 12 Vials/Pk
REF R21923, 10% Formalin, 15ml/Vial ............................ 120 Vials/Pk
REF R21641, 10% Formalin, 15 ml/Vial ........................... 288 Vials/Pk
REF R21928, 5% Formalin, 15 ml/Vial ............................. 120 Vials/Pk
ATCC is a registered trademark of American Type Culture Collection.
IFU 21630, Revised June 12, 2012
12076 Santa Fe Drive, Lenexa, KS 66215, USA
General Information: (800) 255-6730 Website: www.remel.com Email: [email protected]
Local/International Phone: (913) 888-0939 International Fax: (913) 895-4128
Printed in U.S.A.