General GenBio Product Questions

  • How do I contact GenBio?

    Visit the Contact Us Page or Phone Technical Support
    +1 858.592.9300, send and email to support@genbio.com or view information at http://support.GenBio.com.

    contact, technical, support

  • How do I get package inserts for GenBio kits?

    First “register” with GenBio online, then access any package inserts that you need on the website under “Ordering Information” tab. You can also download these at http://support.GenBio.com

    package inserts, kits

  • What are the FDA 510(k) clearance numbers for GenBio kits?

    700-0403, ImmunoDOT and ImmunoWELL FDA notifications

    immunowell, immundot, fda, 510k

  • What GenBio kits are CE marked?

    Contact us via “Contact Us” tab

    immunowell, immundot, ce, mark

  • What is the current definition of quantitative versus semi-quantitative versus qualitative testing as an aid to my comparison of kits?

    700-0528, U.S. Regulatory Interpretations

    immunowell, immundot, quantitative, qualitative, ebv

  • What is the stability of ImmunoDOT and ImmunoWELL kits?

    Innominata dba GenBio has been manufacturing immunoassay kits since 1989
    and maintains an ongoing stability program on all kits manufactured. Contact
    Us for specific inquiries at +1 858-592-9300

    kits, stability, immunodot, immunowell

  • What about EDMA classifications?

    700-0145, EDMA Product Classification Codes for In-Vitro

    immunodot, immunowell, codes, edma, classification, invitro

  • Does GenBio have any recommnedations to validate the Workstation / Heat Block?

    700-0551 Heat Block Validation Report
    GenBio has validated our Workstations, but any heat source able to provide constant temperature near the required assay liquid temperature can be used. This technical report recommends a validation method. Contact technical services for additional information.

    immunodot, workstation, heat, block, temperature, heat block

General GenBio ImmunoDOT Product Questions

  • Is there something to HELP with interpretation and performance of ImmunoDOT tests?

    There are “Interpretation Guides” available from GenBio. These are assay strips with representative “reactions” in serial dilution through the cutoff. Attached are GenBio's guidance document.To obtain a reaction strip, please contact GenBio Technical Services at +1 858.592.9300.
    700-0104, ImmunoDOT Technical Guide
    700-0417, ImmunoDOT Procedural Precautions

    immunodot, technical, support, procedure, problems, precautions, troubleshooting

  • How do we obtain Material Safety Data Sheets (MSDS)?

    Please request from technical service, +1 858.592.9300 or download at http://support.genbio.com

    immunodot, msds

  • What are the CPT codes currently used for reimbursement of GenBio tests?

    700-0106, CPT Code Reference

    immunodot, cpt, codes, reimbursement

  • What is the Quality Control that the lab needs to consider when running any ImmunoDOT kit?

    The individual reagent strips in the ImmunoDOT kits include a “reagent control” which serves to assure that the procedure has been followed. Additionally, serum positive and negative controls are sold separately and should be used to meet the laboratory's quality control protocols.
    700-0414, ImmunoDOT Quality Control

    immunodot, quality, control, positive, negative, reagent

  • What is the general principle for the ImmunoDOT tests since I understand that it is an enzyme immunoassay and reimbursed as such?

    700-0424, ImmunoDOT Test Principle

    immunodot, eia, reimbursement, enzyme

General GenBio ImmunoFLOW Product Questions

  • What is the test procedure?

    All of the ImmunoFLOW tests are designed to be performed using a similar and simple procedure that takes only a few minutes.

    110-0432, ImmunoFLOW Mycoplasma IgM Test package insert

    immuoflow, mycoplasma, myco, igm

  • What is the CLIA complexity of the ImmunoFLOW tests?

    CLIA moderate complexity

    immunoflow, clia, level, moderate, complexity

  • Do you have examples of HSV and Mycoplasma ImmunoFLOW reactions?

    Visit the Contact Us Page or Phone Technical Support
    +1 858.592.9300. You can also access additional support information at http://support.GenBio.com

    immunoflow, mycoplasma, hsv, herpes

General GenBio ImmunoWELL Product Questions

  • What are the “Most Frequently Overlooked” procedural precautions when using the ImmunoWELL tests?

    700-0410, ImmunoWELL Procedural Precautions

    immunowell, technical, support, procedure, problems, precautions, troubleshooting

  • What are the CPT codes currently used for reimbursement of GenBio tests?

    700-0106, CPT Code Reference

    immunowell, cpt, codes

  • Are there CMS interpretation guidelines for ImmunoWELL method?

    700-0151, CMS Interpretation Guidelines for ImmunoWELL

    immunowell, cpt, codes, reimbursement

  • Can any ImmunoWELL kit be run successfully on any “open” microtiter system?

    YES. We suggest you consult with GenBio technical services at
    858-592-9300 for “validation” protocol suggestions to satisfy
    your regulatory requirements.

    immunowell, microtiter, instrument, validation

  • Are there special considerations as far as “negative controls” provided with the ImmunoWELL kits?

    700-0470, ImmunoWELL Negative Control

    immunowell, control, negative, minus, values, results

Mycoplasma

  • How does the ImmunoWELL Mycoplasma kit compare to other commercial kits?

    700-0404, ImmunoWELL Mycoplasma IgM Performance
    RA-0006, Csango, Clinical Microbiology and Infection, December 2004
    RA-0028, Petitjean, Journal of Clinical Microbiology, January 2002
    700-0523, Specific Performance for the ImmunoWELL Mycoplasma IgM antibody kit

    mycoplasma, myco, immunwell, performance, evaluations

  • Since so many people have IgG antibodies to Mycoplasma sp., how does the ImmunoWELL Mycoplasma IgG test perform?

    This report is useful to interpret IgG results.
    700-0489, ImmunoWELL Mycoplasma IgG Interpretation

    mycoplasma, myco, immunwell, performance, evaluations, cutoff

  • What antigen is used for both the ImmunoWELL and the ImmunoFLOW kits and why does it correlate so well with public health reference methods?

    GenBio's kit uses purified complement fixing antigen for IgG and IgM kits. This antigen is made by GenBio and proprietary. It is not available from other manufactures.
    700-0406, Mycoplasma Antigen

    immunoflow, mycoplasma, myco, immunwell, antigen, complement, fixation, correlation

  • How does the ImmunoFLOW Mycoplasma kit compare to ImmunoWELL Mycoplasma kits?

    ImmunoFLOW and ImmunoWELL use the same complement fixing antigen and are made to correlate.
    110-0432, ImmunoFLOW Mycoplasma IgM Test package insert

    immunoflow, mycoplasma, myco, igm, immunwell, antigen, complement, fixation, correlation

  • How does ImmunoWELL Mycoplasma IgM kit compare to the complement fixation

    700-0476, Ortega, 94th General Meeting of the ASM

    mycoplasma, myco, igm, immunwell, antigen, complement, fixation, correlation, abstract

Borrelia

  • How well does the ImmunoDOT Borrelia polyvalent conjugate kit perform?

    700-0514, Specific Performance for ImmunoDOT Borrelia (Lyme)

    immunodot, performance, polyvalent, conjugate

  • Isn’t there a CDC Panel for Borrelia? How do the GenBio kits perform on that CDC panel?

    700-0110, CDC Borrelia Panel Evaluation

    immunodot, immunowell, performance, cdc, cdc panel, lyme, borrelia

  • Has anyone ever tested European strains or Asian strains of Borrelia for reactivity in the GenBio tests?

    Yes. The major immunodominant antigens of Borrelia are conserved across strains from Europe and Asia. No one has ever submitted to us a “confirmed positive” specimen from another continent which was not detected by DotBlot Borrelia and was detected by another immunoassay.

    RA-0014, Grabher, 97th General Meeting of the ASM

    immunodot, immunowell, lyme, borrelia, strains, european, asian

  • How well does ImmunoWELL Borrelia test function as a “higher volume” screening test?

    700-0110, CDC Borrelia Panel Evaluation

    immunowell, lyme, borrelia, screen, high, volume

  • How well does the ImmunoWELL Borrelia kit perform?

    700-0501, Specific Performance for the ImmunoWELL Borrelia test

    immunowell, performance, lyme, borrelia

  • Why is the addition of the NIH licensed p39 recombinant protein important to the ImmunoWELL Borrelia test?

    RA-0008, Fawcett, 5th International Conference on Lyme

    immunodot, immunowell, lyme, borrelia, nih, p39, recombinant, protein

  • What about testing of Cerebral Spinal Fluids for the presence of Borrelial antibodies?

    700-0300, Borrelia CSF Protocol

    immunowell, lyme, borrelia, csf, cerebral, spinal, fluid, cerebral spinal

  • What about borderline results with the ImmunoWELL Borrelia kits?

    700-0454, ImmunoWELL Borrelia (Lyme) Borderline

    immunowell, interpretation, lyme, borrelia, borderline, result

Rickettsia and Coxiella (Q Fever)

  • How did these PanBio products end up at GenBio?

    GenBio made PanBio's dipstick product for several years. When PanBio was acquired by Alere, these products were renamed as ImmunoDOT products. The kits detect Rickettsia, Coxiella, Leptospira and Salmonella antibodies.

    immunodot, panbio, rickettsia, coxiella, q-fever, leptospira, salmonella, lepto

  • Do I really need to consider these kits in my geographic area

    Coxiella (Q Fever) is found world-wide and the ImmunoDOT kit detects all strains. Rickettsia strains cross-reactive but infections are regionally distributed.
    700-0554, Rickettsia and Coxiella

    immunodot, panbio, rickettsia, coxiella, q-fever

  • Where are the most cases of Rocky Mountain Spotted Fever if NOT in the Rocky Mountains?

    RA-0039, CDC, Rocky Mountain Spotted Fever, Questions and Answers

    immunodot, panbio, rickettsia, rocky, mountain, spotted, fever

  • What diseases are associated with Rickettsia?

    RA-0045, CDC, Rickettsial Infections, Yellow Book, CDC

    immunodot, panbio, rickettsia, rocky, mountain, spotted, fever

  • What is Q Fever (Coxiella) and its epidemiology, pathology and clinical findings?

    Coxiella (Q fever) is found world-wide and a common cause of respiratory infections and pneumonia, especially when subjects are exposed to rural environments. See the following reviews for additional information.
    RA-0041, Q FEVER, Clinical Microbiology Reviews, 1999
    RA-0055, Q FEVER, Overview, Diagnosis, Treatment, Significance for Bioterrorism

    immunodot, panbio, coxiella, q-fever

  • Since Coxiella (Q Fever) and Rickettsia are spread by farm animals to humans, how about Q Fever in Europe and Asia?

    Q fever is found world-wide. ImmunoDOT detects all strains and can be used world-wide.
    RA-0043, Eurosurveillance, Q Fever in Europe
    RA-0059, Murine typhus (R. typhi) in Spain
    RA-0058, Rickettsial Seroepidemiology Among Farm Workers in China

    immunodot, panbio, rickettsia, coxiella, q-fever, rocky, mountain, spotted, fever

  • How well does ImmunoDOT (formerly Dip-S-Ticks) Rickettsia conorii (Mediterranean Spotted Fever) test work?

    RA-0056, Laboratory Evaluation of a DotBlot EIA for serological confirmation of illness due to R. conorii
    110-0427, ImmunoDOT Rickettsia conorii antibody test package insert

    immunodot, panbio, rickettsia, conorii, mediterranean.fever

  • How well does ImmunoDOT (formerly Dip-S-Ticks) Rickettsia typhi (typhus) test work?

    RA-0057, Comparative Evaluation of a Commercial EIA for detection of Human Antibody to R. typhi
    110-0428, ImmunoDOT Rickettsia typhi antibody test package insert

    immunodot, panbio, rickettsia, fever, typhi, typhus

  • How well does ImmunoDOT (formerly Dip-S-Ticks) Rickettsia rickettsia (RMSF) test work?

    110-0431, ImmunoDOT Rickettsia rickettsia antibody test package insert

    immunodot, panbio, rickettsia, rocky, mountain, spotted, fever

  • I heard that you can get Rickettsia from your pet?

    RA-0046, Diseases from Dogs, CDC Bulletin

    immunodot, panbio, rickettsia, coxiella, q-fever, rocky, mountain, spotted, fever

Herpes Simplex Virus (HSV)

  • Why is it important to accurately determine if a patient has HSV Type 1 and/or HSV Type 2 antibodies using “recombinant” technologies?

    RA-0022, Malkin, Herpes, The Journal of the IHMF, July 2002

    immunodot, immunowell, recombinant, hsv, herpes, virus

  • Why is genital herpes a “global public health problem”?

    RA-0001, Ballard, http://www.mediscover.net

    immunodot, immunowell, recombinant, hsv, herpes, virus

  • Why is the use of “old type” tests not useful in the diagnosis of “genital herpes” caused by HSV Type 2?

    RA-0025, Morrow, American J. of Obstetrics and Gynecology,Jan 2005

    immunodot, immunowell, recombinant, hsv, herpes, virus

  • What about the use of IgM testing for Herpes Simplex Virus?

    RA-0026, Page, Sexually Transmitted Infections, January 2003

    immunodot, immunowell, igm, recombinant, hsv, herpes, virus

  • Are there any treatments for Genital Herpes?

    www.valtrex.com

    immunodot, immunowell, recombinant, hsv, herpes, virus, valtrex, treatment

Leptospira

  • What is Leptospirosis and how do PEOPLE and animals get it?

    RA-0044, Leptospirosis, Frequently Asked Questions, CDC Bulletin
    RA-0053, Reemerging Leptospirosis in California
    RA-0047, Vector-Borne and Zoonotic Diseases, Under Recognition of Leptospirosis in Hawaii
    RA-0054, Leptospirosis and Unexplained Acute Febrile Illness Among Triathlon Participants, CDC
    700-0553, Leptospira (IgM) Screening Panel

    immunodot, panbio, leptospira, lepto, igm.cdc

  • How can I protect MYSELF and other people when my pet has leptospirosis?

    RA-0040, Leptospira and your pet, CDC Bulletin

    immunodot, panbio, leptospira, lepto, igm.cdc, pet

  • I heard that you can get Leptospirosis from your pet?

    RA-0040, Leptospira and your pet, CDC Bulletin
    RA-0046, Diseases from Dogs, CDC Bulletin

    immunodot, panbio, leptospira, lepto, igm.cdc, pet

  • How well does the ImmunoDOT (formerly PanBio Dip-S-Ticks) Leptospirosis kit work?

    RA-0048, Leptospirosis and Comparative Evaluation of Rapid Diagnostic Kits
    110-0429, ImmunoDOT Leptospira IgM package insert

    immunodot, panbio, leptospira, lepto, igm.cdc

  • I understand that Leptospirosis is an emerging disease in Latin America, Asia and the Caribbean that I should be concerned with while on vacations (swimming, scuba, beach)?

    RA-0052, Outbreak of Acute Febrile Illness Among Participants in EcoChallenge
    RA-0049, Emerging Diseases: Latin America and the Caribbean
    RA-0054, Leptospirosis and Unexplained Acute Febrile Illness Among Triathlon

    immunodot, panbio, leptospira, lepto, igm.cdc, latin, asia, caribbean

  • What about co-infection with Leptospirosis?

    RA-0051, Co-infection with Malaria and Leptospirosis
    RA-0047, Vector-Borne and Zoonotic Diseases, Under Recognition of Leptospirosis in Hawaii

    immunodot, panbio, leptospira, lepto, igm.cdc, infection, malaria

Salmonella

  • How is the ImmunoDOT Salmonella typhi kit used in my laboratory?

    700-0555, ImmunoDOT Salmonella typhi test
    110-0426, Package Insert, ImmunoDOT Salmonella typhi test

    immunodot, panbio, salmonella, typhi

  • How well does the ImmunoDOT Salmonella typhi test work?

    RA-0061, Evaluation of Rapid Diagnostic Tests for Typhoid Fever
    110-0426, Package Insert, ImmunoDOT Salmonella typhi test

    immunodot, panbio, salmonella, typhi

TORCH Testing

  • What is the real purpose of TORCH testing as designed by the Public Health Service many years ago?

    RA-0032, Sever, American Journal of Obstetrics and Gynecology, July 1985
    700-0157, GenBio TORCH Testing

    immunodot, screen, hsv, herpes, torch, public, health, toxo, toxoplasma, rubella, cmv, cytomegalovirus

  • How well does the ImmunoDOT TORCH test perform?

    700-0515, ImmunoDOT TORCH Test Performance Studies
    700-0460, ImmunoDOT TORCH Antibody Test

    immunodot, screen, hsv, herpes, torch, toxo, toxoplasma, rubella, cmv, cytomegalovirus

  • What are the “endpoint titers” for the ImmunoDOT kits since I used to report titers and need to give the doctor some sort of explanation?

    700-0418, GenBio ImmunoDOT Endpoint Titers

    immunodot, screen, hsv, herpes, torch, toxo, toxoplasma, rubella, cmv, cytomegalovirus

  • What antigens are used in the ImmunoDOT TORCH test?

    700-0419, ImmunoDOT TORCH Antigens

    immunodot, screen, hsv, herpes, torch, toxo, toxoplasma, rubella, cmv, cytomegalovirus

Thyroid Autoantibodies

  • What other populations of patients should I also consider when testing for autoimmune thyroiditis?

    RA-0027, Reyes, Clinical and Diagnostic Laboratory Immunology, May 1994

    immunodot, immunowell, prenatal, thyroid, thyroglobulan, tpo, thyroiditis, microsomal, tg

  • What other patients should be tested for anti-TPO antibodies?

    RA-0035, Stagnaro-Green, JAMA, September 1990
    RA-0019, Kutteh, Fertility and Sterility, May 1999

    immunodot, immunowell, prenatal, thyroid, thyroglobulan, tpo, thyroiditis, microsomal, tg

  • Why does using a “recombinant” TPO antigen dramatically improve the usefulness of both the ImmunoDOT and the ImmunoWELL anti-thyroid assays over the older crude antigen assays?

    RA-0007, Endres, AACC In-Service Training, August 1991
    RA-0020, Laboratory Proficiency Testing Program Newsletter, March 1995

    immunodot, immunowell, prenatal, thyroid, thyroglobulan, tpo, microsomal, proficiency, cap, api, pt

  • How do the ImmunoDOT and ImmunoWELL anti-thyroid tests compare as far as performance?

    700-0487, ImmunoDOT Thyroid Performance Comparison to ImmunoWELL Thyroglobulin and TPO kits
    700-0519, Specific Performance for the ImmunoDOT Thyroid kit
    700-0158, CAP Performance ImmunoWELL Thyroglobulin and TPO
    700-0503, Specific Performance for ImmunoWELL TPO kit
    700-0504, Specific Performance for ImmunoWELL Thyroglobulin kit

    immunodot, immunowell, prenatal, thyroid, thyroglobulan, tpo, microsomal, proficiency, cap, api, pt, tg

Cardiolipin Antibodies

  • Can someone explain the relevance of Cardiolipin antibodies in a patient?

    RA-0029, Reddel, Clinical and Diagnostic Laboratory Immunology, November 1999

    immunowell, cardio, cardiolipin, acl

  • How well do the ImmunoWELL Cardiolipin antibody tests perform?

    RA-0037, Wei, Evaluation of GenBio IgG & IgM anti-Cardiolipin Antibody EIAs using Harris Standards

    700-0160, CAP Performance, ImmunoWELL Cardiolipin IgG and IgM
    700-0521, Specific Performance for the ImmunoWELL Cardiolipin IgG antibody kit
    700-0522, Specific Performance for the ImmunoWELL Cardiolipin IgM antibody kit

    immunowell, cardio, cardiolipin, acl

  • Why does the ImmunoWELL Cardiolipin antibody test answer the need for considering the antigens used in the testing

    GenBio includes an important co-factor (beta 2-glycoprotein) in the kit. The co-factor tested alone is not reactive, but when combined with one fatty acid found in cardiolipin antigen, an important IgG specific autoimmune epitope is expressed. GenBio standardizes the co-factor and fatty acid assuring lot to lot consistency.
    700-0099, ImmunoWELL Cardiolipin

    immunowell, cardio, cardiolipin, acl

Epstein - Barr virus and MONO-like Syndrome

    ImmunoDOT MONO
  • How do we obtain Material Safety Data Sheets (MSDS)?

    MSDS is available at http://support.genbio.com or request from technical service, +1 858.592.9300.

    msds, immuowell

  • Why is it important to test for more than just heterophile or EBV (i.e. CMV) when trying to aid the diagnosis of MONO-like syndrome?

    RA-0017, Hodge, American Clinical Laboratory, July 1999

    immunodot, ebv, igm, toxo, cmv, mono, heterophile, vca, ebna, igg

  • What do all of the Epstein-Barr Parameters mean?

    700-0491, EBV Primer
    RA-0023, Manual of Clinical Immunology, Chapter 85

    immunodot, ebv, igm, mono, heterophile, vca, ebna, igg

  • How well do the MONO M and MONO G perform for the diagnosis of MONO-like syndrome?

    700-0615, MONO Proof Sources Summary
    RA-0015, Halling, 98th General Meeting of ASM
    700-0525, Specific Performance for the ImmunoDOT MONO M Test
    700-0526, Specific Performance for the ImmunoDOT MONO G Test

    immunodot, ebv, igm, toxo, cmv, mono, heterophile, vca, ebna, igg

  • Can you describe the nature of the antigens used in the ImmunoDOT MONO tests?

    700-0472, ImmunoDOT MONO G and MONO M antigens

    immunodot, ebv, igm, toxo, cmv, mono, heterophile, vca, ebna, igg

  • Why do you need to test for CMV when considering MONO-like syndrome?

    RA-0021, Lajo, Pediatric Infectious Disease Journal, January 1994

    immunodot, igm, mono, igg, cmvv

  • Why is the quality control of GenBio kits better than most other kits available for EBV?

    700-0498, EBV Quality Control

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  • What is the suggestion for proficiency testing with the MONO G and MONO M kits?

    700-0496, MONO G / MONO M Panels: Proficiency Testing

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  • What is the current definition of quantitative versus semi-quantitative versus qualitative testing as an aid to my comparison of kits?

    700-0528, U.S. Regulatory Interpretations

    immunowell, immundot, quantitative, qualitative, ebv

  • ImmunoWELL EBV
  • What parameters do we need to run when aiding the diagnosis of EBV infections and what do they mean?

    700-0491, EBV Primer
    RA-0016, Hess, Journal of Clinical Microbiology, August 2004
    RA-0023, Manual of Clinical Immunology, Chapter 85

    immunowell, ebv, igm, mono, vca, ebna, igg, diagnosis, ea

  • Why is the quality control of GenBio kits better than most other kits available?

    700-0498, EBV Serology Quality Control

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  • What antigens are used in ImmunoWELL EBV tests?

    700-0471, ImmunoWELL EBV Antigens

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  • How do the ImmunoWELL EBV kits compare to other EBV kits available?

    RA-0013, Gartner, Clinical and Diagnostic Laboratory Immunology, January
    2003
    700-0529, Performance Characteristic Summary, EBV VCA IgG
    700-0530, Performance Characteristic Summary, EBV VCA IgM
    700-0531, Performance Characteristic Summary, EBNA IgG
    700-0532, Performance Characteristic Summary, EBV EA IgG

    immunowell, ebv, igm, performance, mono, vca, ebna, igg, ea

  • What is the difference between ImmunoWELL EBNA IgG test and the old IFA EBNA tests as far as cutoffs and principles?

    700-0479, ImmunoWELL EBNA IgG Support of Cutoff

    immunowell, ebna, igg, ifa, cutoffs

  • What tests are considered when one considers EBV reactivation?

    700-0488, EBV Serology Reactivation Assessment

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  • What is the current definition of quantitative versus semi-quantitative versus qualitative?

    700-0528, U.S. Regulatory Interpretations

    immunowell, immundot, quantitative, qualitative, ebv

Autoimmunity

    Nuclear Autoantibodies
  • How well do the ImmunoDOT Autoimmunity Panels work for detection and confirmation of various “specific” autoantibodies associated with autoimmune disease?

    700-0492, CAP Proficiency Results
    700-0613, Summary of proof sources
    700-0494, Sung-Hwan, Medical Technology Society, Korea 1997
    700-0495, Franchina, Presentation 1998
    700-0506, Specific Performance for the ImmunoDOT Auto 1 kit
    700-0512, Specific Performance for the ImmunoDOT Auto 4 kit
    700-0520, Specific Performance for the ImmunoDOT DNA/ENA kit

    immunodot, performance, cap, ana, rnp/sm, sm/rnp, sm, rnp, ds, dna, dsdna, ssa, ssb, abstracts, ena

  • What are the CPT reimbursement codes for the different ImmunoDOT autoimmune panels?

    700-0106, CPT Code Reference

    immunodot, cpt, codes, ana, rnp/sm, sm/rnp, sm, rnp, ds, dna, dsdna, ssa, ssb, ena

  • Why are there so many ANA positives (IFA or EIA) that cannot be “confirmed” as a disease versus a specific method like ImmunoDOT?

    RA-0030, Reichlin, Bulletin on the Rheumatic Diseases, 1972
    RA-0036, Ward, Laboratory Testing, February 1998
    RA-0033, Slater, Archives of Internal Medicine, July 1996
    RA-0018, Keren, CAP TODAY, January 1996
    RA-0012, Fritzler, Arthritis Research and Therapy, June 2003
    700-0415, ImmunoDOT Autoimmunity Panel 1 Interpretation

    immunodot, positive, eia, performance, cap, ifa, ana, rnp/sm, sm/rnp, sm, rnp, ds, dna, dsdna, ssa, ssb, ena

  • Why are patterns not important since the advent of “specific” antibody tests to detect clinically relevant autoantibodies?

    RA-0024, Muro, Autoimmunity, February 2005

    immunodot, performance, screen, cap, ana, rnp/sm, sm/rnp, sm, rnp, ds, dna, dsdna, ssa, ssb, patterns, ena

  • Why isn’t “titer” important with the advent of newer more modern ANA testing?

    Titer is a means to improve the specificity of an IFA ANA test. The higher the titer the better the positive predictive value of the IFA ANA. When using an immunoassay like ImmunoDOT, the test is standardized by applying a specific antigen amount ("titer"). The amount of antigen ("titer") assures lot to lot consistency and correlates to the kit's performance claims.

    RA-0030, Reichlin, Bulletin on the Rheumatic Diseases, 1972
    RA-0036, Ward, Laboratory Testing, February 1998
    RA-0033, Slater, Archives of Internal Medicine, July 1996
    RA-0018, Keren, CAP TODAY, January 1996

    immunodot, eia, screen, ifa, ana, titer, ena

  • Why is the “high avidity” anti-DNA detected by the ImmunoDOT method (due to use of the ENHANCER step) more important to the patient management than a less specific test?

    Significant differences between assay methods exists. Like the RIA anti-dsDNA assay method (Farr assay method), ImmunoDOT selectively detects higher avidity antibodies when compared to most IFA methods. Based on CAP reported results, ImmunoDOT does compare well to other EIA methods.
    RA-0034, Smeenk, Molecular Biology Reports, 1992.

    immunodot, ana, ds, dna, dsdna, avidity

  • What standardized antigens are used in the ImmunoDOT kits for autoimmune antibody detection?

    700-0458, ImmunoDOT Deoxyribonucleic Acid (DNA) Antigen
    700-0401, GenBio Extractable Nuclear Antigen Characteristics

    immunodot, ana, rnp/sm, sm/rnp, sm, rnp, ds, dna, dsdna, ssa, ssb, ena

  • How are Sm and RNP interpreted since all tests on the market using native antigens combine Sm and RNP antigens and also offer Sm alone?

    700-0402, GenBio Sm/RNP Antigen Interpretation

    immunodot, ana, rnp/sm, sm/rnp, sm, rnp, ena

  • What other autoimmune antibodies should I test given the generalized patient symptoms that triggered ANA testing?

    RA-0027, Reyes, Clinical and Diagnostic Laboratory Immunology, May 1994

    immunodot, thyroid, tpo, microsomal, ana, tsh