POM-V
Prescription Required
Tuberculin PPD Kit
Active ingredients: Avian Tuberculin PPD, Bovine Tuberculin PPD
Form
Injection
Species
Cattle
Manufacturer
Prionics Lelystad B.V.
VMD MA No.
36410/4000
What it's used for
of Bovine Tuberculin PPD 3000 and Avian Tuberculin PPD 2500 and comparing the degree of skin swelling of the two injection sites enables differentiation be...
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Clinical information
Tuberculin PPD Kit — SPC Details
Source: VMD Summary of Product Characteristics (SPC). Last updated 27 Mar 2026.
of Bovine Tuberculin PPD 3000 and Avian Tuberculin PPD 2500 and comparing
the degree of skin swelling of the two injection sites enables differentiation
between the specific reaction in target species exposed to species
causing bovine tuberculosis and the non-specific reaction in target species, which
have been exposed to other species of Mycobacteria or related genera, causing
cross sensitisation to Bovine Tuberculin PPD 3000.
the degree of skin swelling of the two injection sites enables differentiation
between the specific reaction in target species exposed to species
causing bovine tuberculosis and the non-specific reaction in target species, which
have been exposed to other species of Mycobacteria or related genera, causing
cross sensitisation to Bovine Tuberculin PPD 3000.
(10 cm) below the crest. The lower site should be about five inches (12.5 cm) from
the upper site, on a line drawn parallel with the line of the shoulder. In young
animals where there is insufficient space to inject both tuberculin PPDs into the
same side of the neck, the tuberculin PPDs should be injected, one on each side
of the neck, at corresponding sites in the centre of the middle third of the neck. In
animals, which have non-associated lumps or swellings proximal to the injection
site(s) the tuberculin PPD should be injected into the opposite side of the neck.
Preparation of sites of injection:
The selected sites of injection should be clipped (an adequately sized area for
identification of the injection sites), cleansed (with water alone) if obviously dirty,
and debris should be removed prior to injection. The presence of any
abnormalities near to the injection site(s) should be recorded. The presence of
skin tuberculosis should also be recorded.
Measurement of skin thickness prior injection:
Before injection, a fold of skin at each of the intended injection sites and within the
clipped area must be taken between the forefinger and thumb and accurately
measured to the nearest millimetre using callipers.
Intradermal injection:
A correct intradermal injection technique and the delivery of the prescribed dose
volume of 0.1 ml per injection are important for a reliable test result. A correct
injection is confirmed by palpating a small pea-like swelling at each injection site. If
there is any doubt about either of the injections being delivered intradermally, a
further injection should be made, preferably at a corresponding site on the other
side of the neck.
Reading of the tuberculin test after injection:
The injection sites should be palpated carefully to detect reactions 72 hours (+/- 4
hours) after intradermal injection and the skin-fold thickness of each injection site
re-measured. The same person should measure the skin before the injection and
when the test is read.
Measurements of the injection site must be taken carefully by placing the callipers,
where a response (swelling) has been detected, across the broadest width of the
swelling, without applying undue pressure.
Clinical signs compatible with bovine tuberculosis must be recorded at the time of
reading to assist in the identification of animals that may be exposed but which
have not been identified as reactors in the SICCT test (i.e. false negatives).
The presence of clinical signs, 72 hours after injection of tuberculin PPD, such as
diffuse or extensive oedema, exudation, necrosis, pain or inflammation of the
lymphatic ducts in that region or of the regional (pre-scapular) lymph nodes, is
indicative of likely exposure to Mycobacterium species causing bovine tuberculosis
(i.e., a member of the Mycobacterium tuberculosis complex). The person
AN: 04153/2024 & 04157/2024
performing the test should carefully examine and record any such signs.
Especially in case of necrosis in absence of any other clinical signs that are
symptomatic of bovine tuberculosis, the tester should be cautious in making the
correct interpretation. In case of doubt the competent authority may require
additional diagnostic measures.
Interpretation of the Single Intradermal Comparative Cervical Tuberculin (SICCT)
test:
For the establishment and maintenance of officially tuberculosis-free herd status
for the purpose of internal EU trading in bovines, the interpretation of the skin
reactions induced by the bovine and avian tuberculin PPD injections should be
made according to the guidelines (“Intradermal Tuberculin Skin Test Protocol in
Bovine Animals”) published by the EU Reference Laboratory for bovine
tuberculosis at:
https://www.visavet.es/bovinetuberculosis/databases/protocols.php
Interpretation of
skin reactions of
the SICCT test
Clinical observations and the recorded increases in
skin-fold thickness at the sites of injection 72 hours
after injection of the Tuberculin PPDs.
Positive reactionA reaction to bovine tuberculin PPD which is more than 4
mm greater than the reaction to avian tuberculin PPD, or
the presence of clinical signs.
Inconclusive
reaction
A reaction to bovine tuberculin PPD (of at least 2 mm)
which is from 1 to 4 mm greater than the reaction to avian
tuberculin PPD, and the absence of clinical signs.
Negative reactionA reaction to bovine tuberculin PPD which is equal to or
less than the reaction to avian tuberculin PPD, and the
absence of clinical signs.
Animals inconclusive to the SICCT test that are not removed, either voluntarily by
the animal owner or by the competent authority, shall be subjected to another test
after a minimum of 42 days. Animals, which are not negative to this second test,
shall be deemed positive to the test.
National requirements for a more severe interpretation of the skin reactions may
apply.
the upper site, on a line drawn parallel with the line of the shoulder. In young
animals where there is insufficient space to inject both tuberculin PPDs into the
same side of the neck, the tuberculin PPDs should be injected, one on each side
of the neck, at corresponding sites in the centre of the middle third of the neck. In
animals, which have non-associated lumps or swellings proximal to the injection
site(s) the tuberculin PPD should be injected into the opposite side of the neck.
Preparation of sites of injection:
The selected sites of injection should be clipped (an adequately sized area for
identification of the injection sites), cleansed (with water alone) if obviously dirty,
and debris should be removed prior to injection. The presence of any
abnormalities near to the injection site(s) should be recorded. The presence of
skin tuberculosis should also be recorded.
Measurement of skin thickness prior injection:
Before injection, a fold of skin at each of the intended injection sites and within the
clipped area must be taken between the forefinger and thumb and accurately
measured to the nearest millimetre using callipers.
Intradermal injection:
A correct intradermal injection technique and the delivery of the prescribed dose
volume of 0.1 ml per injection are important for a reliable test result. A correct
injection is confirmed by palpating a small pea-like swelling at each injection site. If
there is any doubt about either of the injections being delivered intradermally, a
further injection should be made, preferably at a corresponding site on the other
side of the neck.
Reading of the tuberculin test after injection:
The injection sites should be palpated carefully to detect reactions 72 hours (+/- 4
hours) after intradermal injection and the skin-fold thickness of each injection site
re-measured. The same person should measure the skin before the injection and
when the test is read.
Measurements of the injection site must be taken carefully by placing the callipers,
where a response (swelling) has been detected, across the broadest width of the
swelling, without applying undue pressure.
Clinical signs compatible with bovine tuberculosis must be recorded at the time of
reading to assist in the identification of animals that may be exposed but which
have not been identified as reactors in the SICCT test (i.e. false negatives).
The presence of clinical signs, 72 hours after injection of tuberculin PPD, such as
diffuse or extensive oedema, exudation, necrosis, pain or inflammation of the
lymphatic ducts in that region or of the regional (pre-scapular) lymph nodes, is
indicative of likely exposure to Mycobacterium species causing bovine tuberculosis
(i.e., a member of the Mycobacterium tuberculosis complex). The person
AN: 04153/2024 & 04157/2024
performing the test should carefully examine and record any such signs.
Especially in case of necrosis in absence of any other clinical signs that are
symptomatic of bovine tuberculosis, the tester should be cautious in making the
correct interpretation. In case of doubt the competent authority may require
additional diagnostic measures.
Interpretation of the Single Intradermal Comparative Cervical Tuberculin (SICCT)
test:
For the establishment and maintenance of officially tuberculosis-free herd status
for the purpose of internal EU trading in bovines, the interpretation of the skin
reactions induced by the bovine and avian tuberculin PPD injections should be
made according to the guidelines (“Intradermal Tuberculin Skin Test Protocol in
Bovine Animals”) published by the EU Reference Laboratory for bovine
tuberculosis at:
https://www.visavet.es/bovinetuberculosis/databases/protocols.php
Interpretation of
skin reactions of
the SICCT test
Clinical observations and the recorded increases in
skin-fold thickness at the sites of injection 72 hours
after injection of the Tuberculin PPDs.
Positive reactionA reaction to bovine tuberculin PPD which is more than 4
mm greater than the reaction to avian tuberculin PPD, or
the presence of clinical signs.
Inconclusive
reaction
A reaction to bovine tuberculin PPD (of at least 2 mm)
which is from 1 to 4 mm greater than the reaction to avian
tuberculin PPD, and the absence of clinical signs.
Negative reactionA reaction to bovine tuberculin PPD which is equal to or
less than the reaction to avian tuberculin PPD, and the
absence of clinical signs.
Animals inconclusive to the SICCT test that are not removed, either voluntarily by
the animal owner or by the competent authority, shall be subjected to another test
after a minimum of 42 days. Animals, which are not negative to this second test,
shall be deemed positive to the test.
National requirements for a more severe interpretation of the skin reactions may
apply.
None.
Target species: Cattle:
Very common
(>1 animal / 10 animals
treated):
Injection site swellingUncommon
(1 to 10 animals / 1,000
Elevated temperature**
AN: 04153/2024 & 04157/2024
animals treated):
* Shortly after administration, in particular in cattle infected with Mycobacterium
bovis. In uninfected animals this swelling will greatly decrease in size within 24
hours and completely disappear within 3 to 4 days. In infected cattle and/or in
cattle sensitised with non-specific mycobacteria the initial swelling, in uncommon
cases up to 65mm, will also decrease in size within 24 hours but it will take up to 4
weeks before the swelling has completely disappeared.
** In infected cattle, will return to normal within 24 hours
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian,
to either the marketing authorisation holder or the national competent authority via
the national reporting system. See the package leaflet for respective contact
details.
Very common
(>1 animal / 10 animals
treated):
Injection site swellingUncommon
(1 to 10 animals / 1,000
Elevated temperature**
AN: 04153/2024 & 04157/2024
animals treated):
* Shortly after administration, in particular in cattle infected with Mycobacterium
bovis. In uninfected animals this swelling will greatly decrease in size within 24
hours and completely disappear within 3 to 4 days. In infected cattle and/or in
cattle sensitised with non-specific mycobacteria the initial swelling, in uncommon
cases up to 65mm, will also decrease in size within 24 hours but it will take up to 4
weeks before the swelling has completely disappeared.
** In infected cattle, will return to normal within 24 hours
Reporting adverse events is important. It allows continuous safety monitoring of a
veterinary medicinal product. Reports should be sent, preferably via a veterinarian,
to either the marketing authorisation holder or the national competent authority via
the national reporting system. See the package leaflet for respective contact
details.
For a reliable result of the Single Intradermal Comparative Cervical Tuberculin
(SICCT) test the use of the veterinary medicinal product in cattle should be
avoided within 42 days following a previous administration of tuberculin PPDs. In
specific circumstances, a time interval shorter than 42 days may not be avoided
e.g. when a herd undergoing test may include recently acquired (and tested)
animals. However, it has been observed that a shorter time interval between tests
results in a potential loss of skin responsiveness and is therefore not
recommended.
The reliability of the test depends upon the proper intradermal injection of the
tuberculin PPDs (Bovine and Avian Tuberculin PPDs) together with the accurate
measurement, characterisation, and comparison of the skin reactions 72 hours
later. Subcutaneous instead of intradermal injection of tuberculin PPDs may give
rise to a false result and is also likely to lead to desensitisation of the animal for a
variable period.
The reliability of the test is also influenced by the site of injection of the tuberculin
PPD (see 3.9) and by the amount of tuberculin PPD administered; doses less than
the prescribed amount of 0.1 ml are likely to lead to a false result of the SICCT
test.
AN: 04153/2024 & 04157/2024
The sensitivity of the test can be influenced by concurrent infection with
Mycobacterium species that do not cause bovine tuberculosis. The interval since
infection with Mycobacterium species causing bovine tuberculosis, either where an
immune response has not had sufficient time to develop, or where the immune
response period has been superseded, might also contribute to a lower sensitivity.
Notice must be taken that the response is ordinarily somewhat depressed in the
peri-parturient period.
In the event of a fulminating infection a response to the intradermal test can even
be absent.
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
In case of accidental self-injection persons who have been exposed to tuberculin
protein, either from a previous tuberculosis vaccination, or from environmental
exposure may expect a reaction. Over 48 to 72 hours this will cause a skin
reaction of a hard, dense wheal. Mild itching, swelling, or irritation at the site of the
injection are frequent reactions. If a strong reaction or systemic symptoms occur
seek medical advice immediately. Show the package leaflet or the label to the
physician.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Disease spread precautions.
Personal protective equipment consisting of suitable protective clothing and
footwear should be worn when conducting tuberculin tests. All practicable
measures of cleaning and disinfection of protective clothing, footwear, hands and
equipment (syringes, etc.) should be undertaken on entry and exit from the holding
to minimise the risk of disease transfer.
(SICCT) test the use of the veterinary medicinal product in cattle should be
avoided within 42 days following a previous administration of tuberculin PPDs. In
specific circumstances, a time interval shorter than 42 days may not be avoided
e.g. when a herd undergoing test may include recently acquired (and tested)
animals. However, it has been observed that a shorter time interval between tests
results in a potential loss of skin responsiveness and is therefore not
recommended.
The reliability of the test depends upon the proper intradermal injection of the
tuberculin PPDs (Bovine and Avian Tuberculin PPDs) together with the accurate
measurement, characterisation, and comparison of the skin reactions 72 hours
later. Subcutaneous instead of intradermal injection of tuberculin PPDs may give
rise to a false result and is also likely to lead to desensitisation of the animal for a
variable period.
The reliability of the test is also influenced by the site of injection of the tuberculin
PPD (see 3.9) and by the amount of tuberculin PPD administered; doses less than
the prescribed amount of 0.1 ml are likely to lead to a false result of the SICCT
test.
AN: 04153/2024 & 04157/2024
The sensitivity of the test can be influenced by concurrent infection with
Mycobacterium species that do not cause bovine tuberculosis. The interval since
infection with Mycobacterium species causing bovine tuberculosis, either where an
immune response has not had sufficient time to develop, or where the immune
response period has been superseded, might also contribute to a lower sensitivity.
Notice must be taken that the response is ordinarily somewhat depressed in the
peri-parturient period.
In the event of a fulminating infection a response to the intradermal test can even
be absent.
Special precautions for safe use in the target species:
Not applicable.
Special precautions to be taken by the person administering the veterinary
medicinal product to animals
In case of accidental self-injection persons who have been exposed to tuberculin
protein, either from a previous tuberculosis vaccination, or from environmental
exposure may expect a reaction. Over 48 to 72 hours this will cause a skin
reaction of a hard, dense wheal. Mild itching, swelling, or irritation at the site of the
injection are frequent reactions. If a strong reaction or systemic symptoms occur
seek medical advice immediately. Show the package leaflet or the label to the
physician.
Special precautions for the protection of the environment:
Not applicable.
Other precautions:
Disease spread precautions.
Personal protective equipment consisting of suitable protective clothing and
footwear should be worn when conducting tuberculin tests. All practicable
measures of cleaning and disinfection of protective clothing, footwear, hands and
equipment (syringes, etc.) should be undertaken on entry and exit from the holding
to minimise the risk of disease transfer.
Injection of other products at or adjacent to the site of tuberculin PPD injection
should be avoided during the period immediately prior to tuberculin PPD injection
and until the completion of the reading of the tuberculin test. Possible reactions
due to such other products could be confused with, or otherwise affect, the
delayed type hypersensitivity reaction due to the administration of tuberculin
PPDs.
Where administration of a medicinal product is necessary such product should not
be administered near to the injection sites of Tuberculin PPD Kit and preferably
not on the same side of the neck.
In general it is recommended that no other veterinary medicinal product should be
administered before and after administration of Tuberculin PPD Kit.
In particular, the veterinary medicinal product should not be used in cattle which
recently have been treated with immunosuppressive medicines such as
glucocorticosteroids since such a treatment may influence the results of the
tuberculin test.
A more severe interpretation of the tuberculin skin test may be required in animals
vaccinated against Johne’s Disease (paratuberculosis), as vaccination could give
rise to false negative SICCT test results in such animals.
N.B. Vaccination of cattle against bovine tuberculosis is currently forbidden in the
European Union.
AN: 04153/2024 & 04157/2024
should be avoided during the period immediately prior to tuberculin PPD injection
and until the completion of the reading of the tuberculin test. Possible reactions
due to such other products could be confused with, or otherwise affect, the
delayed type hypersensitivity reaction due to the administration of tuberculin
PPDs.
Where administration of a medicinal product is necessary such product should not
be administered near to the injection sites of Tuberculin PPD Kit and preferably
not on the same side of the neck.
In general it is recommended that no other veterinary medicinal product should be
administered before and after administration of Tuberculin PPD Kit.
In particular, the veterinary medicinal product should not be used in cattle which
recently have been treated with immunosuppressive medicines such as
glucocorticosteroids since such a treatment may influence the results of the
tuberculin test.
A more severe interpretation of the tuberculin skin test may be required in animals
vaccinated against Johne’s Disease (paratuberculosis), as vaccination could give
rise to false negative SICCT test results in such animals.
N.B. Vaccination of cattle against bovine tuberculosis is currently forbidden in the
European Union.
AN: 04153/2024 & 04157/2024
Store in a refrigerator (2 °C - 8 °C).
Do not freeze.
Keep the vials in the polystyrene box, closed with carton sleeve, in order to protect
from light.
Transportation:
May be transported at 2 °C - 37 °C for a period not longer than 14 days.
Do not freeze.
Keep the vials in the polystyrene box, closed with carton sleeves, in order to
protect from light.
Do not freeze.
Keep the vials in the polystyrene box, closed with carton sleeve, in order to protect
from light.
Transportation:
May be transported at 2 °C - 37 °C for a period not longer than 14 days.
Do not freeze.
Keep the vials in the polystyrene box, closed with carton sleeves, in order to
protect from light.
Zero days.
This information is sourced from the official Summary of Product Characteristics (SPC) published by the Veterinary Medicines Directorate (VMD). It is provided for informational purposes only and does not replace professional veterinary advice. Always consult your vet before administering any medication.
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