Frequently Asked Questions

The kit is free of charge. It can be ordered by e-mail info@arminlabs.com or telephone 0049 821 780 931 50.

This information you can see here (COMING SOON) For more information, please ask by e-mail info@arminlabs.com or telephone 0049 821 780 931 50.

Within Germany - free of charge. With Go Logistics. Please order the courier by phone or e-mail, 1-2 days before the blood collection. Outside Germany (foreign countries) shipping is via UPS, DHL or Fedex. Please ask for the prices by e-mail or phone.

ArminLabs is certified by the German Accreditation Board DAkks, international accreditation no. DIN EN ISO 15189:2014. ArminLabs is also internationally accredited by CAP (College of American Pathologists) and verified by CLIA (Clinical Laboratory Improvement Amendments). We do not carry out any in-house tests of our own design. Every test we perform is commercially available, certified and validated internally by ArminLabs and externally by the test producers. For every test a positive and a negative control is always being performed to check for influencing factors.

The decision depends on the recommendation and advice of your health professionals. Furthermore, there are no studies, not are there any references from test manufacturers, that the test can be impaired by antibiotics or other medications. Massive, high dosed chemotherapeutics (cytostatic), immune suppressants or interferon gamma might affect the test results. We recommend a consultation with the attending health professional in such cases.

Generally we recommend : Before antibiotics: immediately testing with Elispots. During antibotics short term (=2-3 weeks antibiotics): Wait 3-5 days after stopping antibiotic pill, take the blood and take antibiotic pills again for the rest of time. During antibiotics long term (4-8-12 weeks antibotics):  Wait 3-5 days after stopping antibiotic pill, take the blood and take antibiotic pills again for the rest of time. After antibiotics short term: Wait 3-5 days till taking blood. After antibiotics long term (4-8-12 weeks antibiotics): Wait 4-6 weeks

It usually takes about 1-7 days to receive test results. But it can take longer depending on the number of tests and their complexity.

We use cell tests - EliSpot/iSpot, immunological tests – ELISA/EIA for the determination of antibodies and immunoblotting (Western blotting) for a rapid and sensitive assay for the detection and characterization of specific proteins formed in antigen-antibody detection and direct PCR tests.

T-cell tests determine the activity against Borrelia and other infections, reflects current activity for the previous 6-8 weeks, no seronegative issues, as this is not an antibody test, Cytokine production can still be measured during a down regulated humoral immune response. -Sensitivity: 1 per 200.000 cells-Specificity: 82-100%-Requires interpretation by a specialized health professional. Preanalytical handling critical (transit time).

Compared to the EliSpot standard assay (which is based only on variability in correlation with the number of activated T cells and secreted IFN-g), the iSpot assay is based on variability in correlation with the number of activated T cells and secreted IFN-g and IL2. IFN-γ is associated with acute or active infection, while IL2 represents the memory function of the immune system and thus convalescence. EliSpot/iSpot provides accurate information about the current, or reactive situation in relation to the presence or absence of infection. In some cases, a positive EliSpot test can be associated with autoimmune diseases: Collagenosis, Rheumatoid Arthritis, Vasculitis etc.

With EliSpot: Borrelia burgdorferi, Borrelia miyamotoi,

Anaplasma / Ehrlichia, Bartonella henselae, Babesia microti, Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Yersinia, Rickettsia, Epstein Barr Virus (EBV), Herpes Simplex Virus (HSV 1/2), Cytomegalovirus (CMV), Varizella Zoster Virus (VZV), HHV6, HHV7, Candida albicans, Aspergillus Peptide Mix 1 & 2. With i-Spot: Borrelia burgdorferi, Borrelia miyamotoi, Anaplasma / Ehrlichia, Bartonella henselae, Babesia microti, Chlamydia pneumoniae, Chlamydia trachomatis, Mycoplasma pneumoniae, Yersinia, Rickettsia, Herpes Simplex Virus (HSV 1/2), Varizella Zoster Virus (VZV), HHV6, HHV7, Candida albicans.

The cut off values are according to the manufacturer’s recommendations

The EliSpot method offers an opportunity to gain insight into this protective immune defense. It detects the IFN-gamma reaction of pathogen-specific activated T cells. The EliSpot is a quantitative evaluation and the numbers refer to the number of activated T cells (within the sample) due to their cytokine release (each reaction triggers a spot). The results are expressed in SI units (SI=Stimulation index).

Band “0 - 1 = negative” 0-1 is the stimulation index, which equals the negative control. 1 spot is, according to the manufacturer, not significant for an infection. Nevertheless, EliSpot results have to be interpreted within the patient’s overall clinical picture. A negative result does not completely exclude the exposure to the pathogen or infection being tested. Preanalytic influencing factors which can lead to an unspecific result of cytokine release, can be asked at ArminLabs.

Band “2 - 3 = weak positive” The infection fluctuates in the human body, the activated T cells do too. A weak positive result of between 2-3 SI units is a borderline result, which is not necessarily positive. Again, the interpretation of the results of the EliSpot assay may only be performed taking into account the overall clinical picture.

Band “>3 = positive” a negative and positive control is performed for each patient. If the controls are not in order, the test cannot be evaluated. With a typical test result, no or very few spots (<10) are to be expected in the negative control. The positive control should be >20 spots. In the event of strongly pre-stimulated samples, ArminLabs informs the patient/therapist that the test should be repeated. A new test kit will be sent upon request. The result >3 refers to a high number of SI units. If the positive and negative control are in order, this result evidences a high cytokine production against Borrelia.

Borrelia b Full antigen: Borrelia burgdorferi B31 reference strain (Borrelia burgdorferi sensu stricto) lysate of Borrelia burgdorferi contains many different antigens capable of evidencing cellular activity

Borrelia b OSP-mix: Borrelia burgorferi peptide mix: OspA of Borrelia b. sensu stricto, Borrelia afzelii, Borrelia garinii + OspC native + DbpA recombinant - special antigens with higher specificity than the lysate, due to less interfering factors; the antigens of the Borrelia burgdorferi OSP-mix are the most specific antigens from the lysate and lead to an overall higher significance

Borrelia burgdorferi LFA-1: Borrelia burgdorferi LFA-1 (Lymphocyte Function Antigen 1): Protein of the body + Borrelia burgdorferi sensustricto (shared epitope). LFA-1 is frequently associated with autoimmune diseases like Collagenoses,rheumatoid arthritis, vasculitis (ANA, CCP antibodies, ANCA). It helps to decide whether the patient issuffering from an active infection or an autoimmune disease.

No, the Lyme EliSpot can’t show a positive result for past infections if you don’t have a recent/currentinfection. Lymphocytes have a life cycle of maximum 6 weeks. That’s why the Lyme EliSpot can be used tomonitor treatment progress and success. IgG antibodies can be used to detect past infections.

The EliSpot measures IFN-gamma secretion from TH1 effector cells.

T-cell activity is already increased after 2-3 days (while the IgM antibody titer may still be negative), and is already clearly decreasing after approx. 6 - 8 weeks after the end of successful therapy (IgM/IgG antibodies often only decrease after 6 - 12 months). So, the EliSpot can be used for swift and targeted monitoring of how therapies are working.

Using ELISA/EIA and microarray methods, we test for the presence of antibodies - IgM or IgA antibodies for the acute or current phase of infection but in some cases a positive IgM or IgA test (alone) may be associated with cross-reactivity to viral infections and IgG antibodies for the chronic phase of disease or "old immunity" or antibody after Immunization - and with immunoblotting for the presence of the specific proteins of the pathogen.

There is a long list of foods that I do not eat every week or month. How long ago must I have eaten the food for the test to be effective? The half-life of antibody producing lymphocytes is 5-6 weeks. IgG’s generally have a half-life of 23 days. Therefore, it will take around 6-9 months to eliminate IgG antibodies when you strictly avoid the foods in question. This depends on several factors: the amount of IgG present (The higher the existing concentration, the longer it will take.) the strictness of avoidance possible cross reactivity to non-foods (Food can cross react with non-food items, such as pollen, viruses, and or dust mites. If such a cross reaction exists, it may take a very long time to eliminate the IgG’s or in some cases, they don’t disappear at all. This is mostly the case when you have never eaten the food before and still have antibodies present. Therefore, the antibody wasn’t triggered by the food, but by a non-food antigen of an unknown origin or which is ubiquitously present.)

Serological detection of IgM antibodies against Borrelia burgdorferi is possible in 50% to 90% of Stage I patients. The prevalence of specific IgG antibodies is significantly lower. At this stage of the disease, however, serological evidence is often negative. If the corresponding symptoms are present, a follow-up in the following weeks is recommended. Stage 2: Antibodies are detectable in Stage II in 50% to 90% of patients. In the early phase of this stage, antibodies of the IgM class are predominantly still positive, in the late phase only antibodies of the IgG class often occur. However, IgM class antibodies can also persist for a long time. Stage 3: At this stage, IgG class antibodies for persisted forms are significantly elevated in 90% to 100% of patients, while IgM class antibodies are rarely detectable.

The TickPlex is an antibody screening assay and is performed on the basis of an ELISA. However, compared to other ELISA assays, this test contains a new antigen for persisted forms of Borrelia. Tick Plex Plus allows the simultaneous determination of multiple pathogens in the complexity of tick-borne infections with a high sensitivity of approximately 95% and a specificity of 98%. Tick Plex Basic/ Tick Plex Plus detects IgM and Ig G antibodies of various bacterial and viral pathogens at the same time.

TickPlex Basic is suitable for Borrelia burgdorferi sensu stricto, B. afzelii, B. garinii. TickPlex Plus is suitable for Borrelia burgdorferi sensu stricto, B. afzelii, B. garinii, Babesia microti, Bartonella henselae, Ehrlichia chaffeensis, Rickettsia akari, Coxsackievirus Type A16, Epstein-Barr virus, Human parvovirus B19, Mycoplasma fermentans & pneumoniae.

IgM and IgG (combined), sensitivity: 100 %, specificity: 90.2 % - 96,4 %, the test is CE marked.

The Seraspot is a modern Immunoblot. It is a solid-phase immunoassay for the qualitative in vitro determination of human antibodies of the immunoglobulin class IgG and IgM against Borrelia antigens from serum or plasma. The wells of the microtiter plate are coated with recombinant anti genes. The test is quantifiable and allows a more accurate evaluation and lower susceptibility to errors due to the predefined points/spots with specific antigens. The Seraspot also has some different bands to the Western Blot, for example it does not include the p41 band.

Immunoblot-IgG - Sensitivity – 88.5%; Specificity – 99.2 %. Reported bands for-IgG: p18, p19, p20, p21, p58, OspC (p25), p39, p41, p83, LBb, LBa, VlsE- Bg, VlsE- Bb und VlsE- Ba, for IgM: OspC- Bg nativ, OspC- Bb nativ, OspC- Ba nativ, p39, p41, VlsE- Bb. The most important antigen contained in the test is covalently bound, dimeric OspC advanced(European patent EP 2 199 303 A1) from four human pathogenic Borrelia strains (B. afzelii, B.burgdorferi, B. garinii, B. spielmanii). OspC advanced is over 30% more specific than conventional recombinant OspC antigens.

Historically, human NK cells have been identified as CD3− CD56+ CD16± lymphocytes. More recently it has been established that CD57 expression defines functionally discrete sub-populations of NK cells. On T cells, CD57 expression has been regarded as a marker of terminal differentiation and (perhaps wrongly) of anergy and senescence.

The CD57+ cells document the extent of the immune suppression of chronic Lyme disease or other bacterial infections (see above). Based on the current literature, CD57+ cells provide prognostic laboratory parameters during and after the treatment of chronic Lyme disease. Clinical research studies and case studies have shown that chronic Lyme infections are often accompanied by changes in the cellular immune defense. Evidence for this is a decreased number of natural killer cells (NK/CD3-CD56+), in particular, a decreased absolute number of activated NK cells (CD3-CD56+CD57+). While acute Borrelia burgdorferi infections and other diseases show normal CD57+ parameters, chronic Lyme patients often have less than 100 CD57+ cells/μl. According to scientific studies, a suppressed absolute number of CD57+ cells have mainly been observed in patients whose nervous system had been affected, rather than in patients whose tissue or skeleton system has been affected. A decrease of CD57+ cells persist until an improvement in symptoms has been achieved with the use antibiotics and other forms of therapy. In reverse, a decreased CD57+ parameter is seen as a measurable signal of an active chronic Borrelia infection (or of other bacterial infections such as Chlamydia pneumoniae or Mycoplasma pneumoniae), and can be a possible indicator of successful therapy as it rises. In the event of a negative Lyme test, we recommend more intensive history taking, and if necessary, recommend further testing of other bacteria that can suppress TH1 cytokine production and trigger similar symptoms.

CD3+ cells - population of T-lymphocytes

CD56+/ CD3- cells - non-activated functional NK cells

CD45+ cells - specific marker to classify the NK cells

CD19 - population of B-lymphocytes

This means polymerase chain reaction. It's a test to detect genetic material from a specific organism, such as a virus, bacteria, parasites. Human Samples: blood, CSF, biopsies, tissue, body fluids, joint fluid

The Polymerase chain reaction (PCR) is a method for direct detection of a pathogen. The test system used is commercially available and certified. We offer the tick PCR for all medically relevant Borrelia species, including Borrelia miyamotoi, TBE, Anaplasma phagocytophilum, Rickettsia, Babesia, Bartonella. First a multiplex PCR is performed with a PN-Mix using DNA isolated from the tick. The respective biotinylated amplicons are characterized by a hybridization reaction with SSOPs for the pathogens and controls immobilized on nitrocellulose membranes in a distinctive line format.

Checking for the presence of a unique gene of the pathogen gives you undeniable proof of the causative pathogen of the disease if it’s found inthe human body.

Benefits of PCR testing: If the pathogen is detected in the human body, this is undeniable proof of the disease. TickPCRs are a cost-effective method of screening for pathogens, and in the event of symptoms, a good preanalytictool for the physician to decide which treatment might be necessary. Some accident insurance companies alsocover the treatment costs if they have evidence of the “accident” (tick bite and a tick that has tested positive).

Specificity - 100% (depending on primer sequences and accreditation of the PCR test) Sensitivity - varies depending on the sample type and stage of the disease Below are some examples listed from a state institute for externally certified and accredited PCR testing methods.

Within Germany - per invoice after receiving the result. Outside Germany (foreign countries) – prepay per banktransfer or credit card. Usually, we do not accept installment payment. For more information, please ask for the prices by e-mail billing@arminlabs.com or phone 0049 821 780 931 53.

The currently valid version of the laboratory order forms is Version 19.0.