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Medical Disclaimer: This information is for educational purposes only and is not a substitute for professional medical advice.
Non-Standardized Food Allergenic Extract [EPC]
Brucella Abortus is a non-standardized allergenic extract used primarily in clinical immunology for diagnostic skin testing. It belongs to the class of Non-Standardized Food and Plant Allergenic Extracts [EPC] used to evaluate cell-mediated immune responses.
Name
Brucella Abortus
Raw Name
BRUCELLA ABORTUS
Category
Non-Standardized Food Allergenic Extract [EPC]
Drug Count
5
Variant Count
5
Last Verified
February 17, 2026
About Brucella Abortus
Brucella Abortus is a non-standardized allergenic extract used primarily in clinical immunology for diagnostic skin testing. It belongs to the class of Non-Standardized Food and Plant Allergenic Extracts [EPC] used to evaluate cell-mediated immune responses.
Detailed information about Brucella Abortus
This page is for informational purposes only and does not replace medical advice. Consult a qualified healthcare professional before using any medication containing Brucella Abortus.
Brucella Abortus, in its pharmaceutical context, refers to a non-standardized allergenic extract derived from the Brucella abortus bacterium. Historically, this agent has been utilized as a diagnostic tool to assess delayed-type hypersensitivity (DTH) or as a specific skin test antigen to evaluate a patient's prior exposure or immunological reactivity to the Brucella genus. According to the FDA's Established Pharmacologic Class (EPC) system, Brucella Abortus is categorized as a Non-Standardized Food Allergenic Extract [EPC] and a Non-Standardized Plant Allergenic Extract [EPC]. While the bacterium itself is a Gram-negative coccobacillus responsible for bovine brucellosis and undulant fever in humans, the extract is a processed, non-infectious derivative used by immunologists and allergists.
This medication belongs to a broader class of diagnostic allergens that are not standardized, meaning they do not have a defined potency unit (such as Bioequivalent Allergy Units) compared to a national reference standard. Instead, their manufacturing follows traditional methods of extraction and filtration. The FDA has maintained these extracts on the market under specific regulatory pathways for diagnostic products that predate modern standardization requirements. Healthcare providers may utilize this extract to determine if a patient's cellular immune system (T-cell mediated response) recognizes the Brucella antigen, which can be indicative of past infection or a general measure of immunocompetence.
At the molecular level, the Brucella Abortus extract works by triggering a Type IV hypersensitivity reaction, also known as a delayed-type hypersensitivity (DTH) response. When a small amount of the extract is injected intradermally (into the skin), it acts as an exogenous antigen. This antigen is captured by local antigen-presenting cells (APCs), such as Langerhans cells or macrophages. These APCs process the bacterial proteins and present them on their surface via Major Histocompatibility Complex (MHC) Class II molecules.
If the patient has been previously sensitized to Brucella abortus—or if there is cross-reactivity with other similar antigens—memory T-lymphocytes (specifically CD4+ Th1 cells) will recognize the antigen-MHC complex. This recognition triggers the release of pro-inflammatory cytokines, including Interferon-gamma (IFN-γ), Interleukin-2 (IL-2), and Tumor Necrosis Factor-alpha (TNF-α). These cytokines recruit additional macrophages and lymphocytes to the site of injection over a period of 24 to 72 hours. The resulting clinical manifestation is an area of induration (hardness) and erythema (redness). The absence of this reaction in a person known to have been exposed may indicate anergy, a state of immune unresponsiveness often seen in advanced HIV/AIDS, malnutrition, or certain cancers.
As an intradermally administered allergenic extract intended for local diagnostic response, the systemic pharmacokinetic profile of Brucella Abortus differs significantly from oral or intravenous medications.
The primary FDA-recognized use for Brucella Abortus extract is as a diagnostic skin test antigen.
Brucella Abortus is typically available in the following forms:
> Important: Only your healthcare provider can determine if Brucella Abortus is right for your specific condition. This diagnostic tool must be administered by a trained professional in a clinical setting equipped to handle potential allergic emergencies.
The standard adult dose for diagnostic skin testing with Brucella Abortus is 0.1 mL. This dose is administered via intradermal injection, usually on the volar surface (inner side) of the forearm. The concentration of the extract may vary depending on the manufacturer, but the volume remains consistent to ensure a measurable wheal is created during administration.
For the assessment of cell-mediated immunity, the dose is typically part of a multi-antigen panel. If the test is being used specifically to investigate a suspected sensitivity, a more dilute concentration may be used initially to minimize the risk of a severe local reaction. The results are read by a healthcare professional exactly 48 to 72 hours after the injection.
Brucella Abortus extract is not routinely approved for pediatric use in the same manner as standardized vaccines. However, when used for DTH testing in children, the dose is generally the same as the adult dose (0.1 mL), as the goal is to trigger a localized cellular response rather than a systemic effect. Pediatric use must be supervised by a specialist in pediatric allergy or immunology, and the child must be monitored closely for systemic reactions. It is generally not recommended for infants under the age of one due to the immaturity of the cellular immune system, which may result in false-negative findings.
No dosage adjustments are required for patients with renal impairment. Because the extract is administered in a minute volume and acts locally within the skin, the kidneys are not significantly involved in its clearance or the modulation of the diagnostic response.
No dosage adjustments are necessary for patients with hepatic impairment. The metabolism of the allergenic proteins occurs via local tissue proteolysis rather than hepatic pathways.
Elderly patients may exhibit reduced skin reactivity due to age-related changes in the immune system (immunosenescence) or thinning of the dermis. While the dose remains 0.1 mL, healthcare providers should be aware that a smaller reaction (induration) might still be clinically significant in this population. Care should be taken to inject at a site with sufficient skin integrity.
Brucella Abortus is never self-administered. It must be given by a healthcare professional using the following protocol:
Since Brucella Abortus is a one-time diagnostic test, a 'missed dose' usually refers to a missed appointment for the reading of the test. If the test is not read within the 48- to 72-hour window, the results are considered invalid. The test may need to be repeated on the opposite arm after the initial local reaction has completely subsided (usually after 1-2 weeks).
An overdose of Brucella Abortus extract (e.g., injecting more than 0.1 mL or using an excessively concentrated solution) increases the risk of a severe local reaction. Signs of an 'overdose' response include:
In the event of an accidental large-volume injection, the site should be monitored, and the patient should be observed for signs of systemic anaphylaxis. Emergency measures include the administration of epinephrine and antihistamines if a systemic reaction occurs.
> Important: Follow your healthcare provider's dosing instructions. Do not adjust your dose without medical guidance.
Most patients undergoing a skin test with Brucella Abortus will experience localized reactions at the site of the injection. These are generally expected as part of the diagnostic process.
> Warning: Stop taking Brucella Abortus and call your doctor immediately if you experience any of these.
Because Brucella Abortus is a diagnostic agent rather than a chronic medication, long-term side effects are extremely rare. The most significant long-term concern is sensitization. There is a theoretical risk that the skin test itself could sensitize a previously unexposed individual to Brucella antigens, potentially complicating future diagnostic tests or causing a stronger reaction if the person is later exposed to the actual bacterium. Additionally, repeated testing in the same site can lead to localized skin thickening or chronic dermatological changes.
As of the 2026 clinical guidelines, there is no official FDA Black Box Warning for Brucella Abortus non-standardized extracts. However, all allergenic extracts carry a general class warning regarding the risk of Severe Systemic Allergic Reactions. The labeling emphasizes that these products should only be administered by clinicians who are prepared to treat anaphylaxis and that patients must be observed for at least 30 minutes post-injection.
Report any unusual symptoms to your healthcare provider. If you experience a severe reaction, your provider will likely report the event to the FDA’s Vaccine Adverse Event Reporting System (VAERS) or the MedWatch program.
Brucella Abortus extract is intended for intradermal diagnostic use only. It must never be injected intravenously, as this could trigger immediate and catastrophic systemic inflammatory responses or anaphylactic shock. Patients should be screened for any history of severe reactions to bacterial extracts or prior diagnosis of brucellosis before the test is administered.
No FDA black box warnings for Brucella Abortus. However, the FDA requires that the following precaution be prominently displayed on all allergenic extract packaging: "This product may produce serious systemic reactions, including anaphylactic shock. It should be used only by physicians experienced in the administration of allergenic extracts and the treatment of systemic reactions."
There are no specific laboratory monitoring requirements (like blood counts or liver tests) for a single diagnostic dose of Brucella Abortus. The primary monitoring is clinical:
Brucella Abortus generally does not affect the ability to drive or operate machinery. However, if a patient experiences a vasovagal reaction (fainting) due to the needle stick or feels dizzy/unwell after the injection, they should avoid these activities until symptoms have completely resolved.
There is no direct pharmacological interaction between alcohol and Brucella Abortus extract. However, alcohol consumption can cause vasodilation (widening of blood vessels), which might theoretically increase the redness or itching at the injection site. It is generally advisable to avoid heavy alcohol use for 24 hours after the test to ensure the local reaction is not obscured.
As this is a single-dose diagnostic test, 'discontinuation' is not applicable in the traditional sense. However, if a patient has a severe reaction to the first test, they should never be re-tested with this specific extract in the future. There are no withdrawal symptoms associated with this product.
> Important: Discuss all your medical conditions with your healthcare provider before starting Brucella Abortus.
While few drugs are strictly contraindicated, the following should be avoided to ensure the test is accurate:
There are no known food interactions that affect the Brucella Abortus skin test. Unlike oral medications, the absorption and action of this intradermal extract are not influenced by the presence of food in the stomach or specific dietary components like grapefruit or dairy.
For each major interaction, the mechanism involves either the suppression of the cellular immune cascade (reducing the diagnostic accuracy) or the modulation of the body's response to emergency treatments like epinephrine. Management typically involves timing the test appropriately in relation to other medications.
> Important: Tell your doctor about ALL medications, supplements, and herbal products you are taking.
Brucella Abortus must NEVER be used in the following circumstances:
Conditions requiring careful risk-benefit analysis include:
Patients who are allergic to other members of the Brucellaceae family or certain other Gram-negative bacteria may show cross-reactivity. Furthermore, because the extract is non-standardized and contains various bacterial proteins, there is a theoretical risk of cross-sensitivity with other diagnostic bacterial extracts. If you have had a reaction to a "Brucellergen" test in the past, notify your provider immediately.
> Important: Your healthcare provider will evaluate your complete medical history before prescribing Brucella Abortus.
Brucella Abortus is generally classified as FDA Pregnancy Category C. This means that animal reproduction studies have not been conducted, and it is not known whether the extract can cause fetal harm or affect reproduction capacity.
It is not known whether the components of Brucella Abortus extract are excreted in human milk. However, since the dose is minute and administered intradermally, systemic levels in the mother are expected to be negligible.
Renal impairment does not alter the local immune response to Brucella Abortus. No dose adjustment is needed for patients with any stage of chronic kidney disease (CKD) or those on dialysis. The proteins in the extract are not cleared by the kidneys in their active form.
Hepatic impairment (Child-Pugh Class A, B, or C) does not affect the metabolism or the diagnostic accuracy of the Brucella Abortus skin test. The liver is not involved in the Type IV hypersensitivity cascade that the test measures.
> Important: Special populations require individualized medical assessment.
Brucella Abortus extract functions as a diagnostic antigen that elicits a Delayed-Type Hypersensitivity (DTH) reaction. This is a T-cell mediated (Type IV) immune response. Upon intradermal injection, bacterial proteins (antigens) are processed by local dendritic cells and presented to memory Th1 cells. These T-cells, if previously sensitized, secrete cytokines such as IFN-gamma and TNF-beta. These signals recruit monocytes from the bloodstream, which transform into macrophages at the site. This influx of cells and fluid creates the characteristic firm swelling known as induration. This process takes 48 to 72 hours to reach its peak, which is why the test cannot be read immediately.
| Parameter | Value |
|---|---|
| Bioavailability | N/A (Intradermal local action) |
| Protein Binding | Minimal (Localized to tissue) |
| Half-life | ~24-48 hours (Local degradation) |
| Tmax | 48-72 hours (Peak of immune response) |
| Metabolism | Local Proteolysis |
| Excretion | Lymphatic clearance |
Brucella Abortus is classified as a Non-Standardized Allergenic Extract. It is grouped with other diagnostic antigens like Coccidioidin, Histoplasmin, and Mumps Skin Test Antigen. Unlike vaccines, it does not confer immunity; it only detects its presence.
Common questions about Brucella Abortus
Brucella Abortus extract is primarily used as a diagnostic tool to test for delayed-type hypersensitivity (DTH). This helps healthcare providers determine if a patient's cellular immune system is functioning correctly. In some cases, it was used to detect prior exposure to the bacteria that cause brucellosis, an infection often caught from animals. It is administered as a tiny injection just under the skin of the forearm. The resulting skin reaction tells the doctor how your T-cells respond to the antigen.
The most common side effects are localized to the area where the injection was given. Patients frequently experience redness, itching, and a hard, raised bump called an induration. Some people may also feel slight soreness or tenderness in the arm for a few days. These reactions are actually a sign that the test is working as intended. Most local symptoms disappear within a week without any specific treatment.
There is no known direct interaction between alcohol and the Brucella Abortus extract. However, because alcohol can cause skin flushing and vasodilation, it might make the injection site appear redder than usual. This could potentially make it harder for your doctor to accurately read the test. It is best to avoid heavy drinking for the 48 to 72 hours between the injection and the follow-up appointment. Always follow the specific advice of your healthcare provider regarding lifestyle choices during diagnostic testing.
Brucella Abortus is a Category C medication, meaning its safety during pregnancy has not been fully established. While there is no evidence that it causes birth defects, doctors usually avoid giving skin tests to pregnant women unless it is absolutely necessary. The main concern is the rare risk of a severe allergic reaction, which could be stressful for both the mother and the baby. If you are pregnant or planning to become pregnant, tell your doctor before having this test. Most of the time, the test can be safely delayed until after the baby is born.
The Brucella Abortus skin test does not provide immediate results. It relies on a delayed-type hypersensitivity reaction, which takes time for immune cells to migrate to the injection site. You will need to return to your doctor's office exactly 48 to 72 hours after the injection to have the results read. If the site is checked too early or too late, the measurement may be inaccurate. During this waiting period, you should avoid scratching or putting creams on the injection site.
Brucella Abortus is not a daily medication, so 'stopping' it is not applicable. It is a single diagnostic injection given by a healthcare professional. Once the injection is administered, the immune response will occur naturally over the next few days. There are no withdrawal symptoms or long-term dependencies associated with this extract. If you decide you do not want the test after the injection has been given, you simply do not return for the reading, though this would mean the test was wasted.
Since this is a one-time diagnostic test performed in a clinic, you cannot 'miss a dose' at home. However, if you miss your follow-up appointment to have the test read (48-72 hours later), the test will be invalid. You should contact your doctor immediately to see if the reaction can still be measured. If too much time has passed, the reaction may have faded, and you might need to repeat the test on your other arm at a later date. Consistency in timing is crucial for an accurate diagnosis.
No, Brucella Abortus extract does not cause weight gain. It is a single, 0.1 mL injection of bacterial proteins used for diagnostic purposes. It does not contain hormones, calories, or any metabolic-altering substances that could lead to changes in body weight. Any weight fluctuations experienced around the time of the test are likely due to other factors or unrelated medical conditions. If you have concerns about weight changes, discuss them with your primary care physician.
Brucella Abortus can be affected by certain medications that suppress the immune system. Drugs like high-dose prednisone, chemotherapy, or other immunosuppressants can cause a 'false negative' result because the body cannot react to the test. Antihistamines may also reduce the visible redness at the site. It is very important to give your doctor a full list of all medications you are taking, including over-the-counter drugs and supplements. They will tell you if you need to temporarily stop any medications before the test.
Brucella Abortus is a non-standardized biological extract rather than a traditional chemical drug, so the concept of 'generic' is slightly different. It is produced by a few specialized laboratories that manufacture allergenic extracts. While there may be different brands or manufacturers, they are all considered non-standardized products. Because these extracts are used in very specific clinical settings, you won't find them at a standard retail pharmacy. Your immunologist or allergist will source the extract directly from a licensed biological manufacturer.