15222 Avenue of Science, Suite A
San Diego, CA 92128
Toll Free 800-288-IDOT (4368)
FAX: +1 858.592.9400
General GenBio Product Questions:
- How do I contact GenBio?
Visit the Contact Us Page
Phone: 800-288-4368 - 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.
- What about shipping, storage and stability?
700-0102, Product Shipping, Storage and Stability
- What about EDMA classifications?
700-0145, EDMA Product Classification Codes for In-Vitro
- What are the FDA 510(k) clearance numbers for GenBio kits?
700-0403, ImmunoDOT and ImmunoWELL FDA notifications
- What are the “CE” mark numbers for GenBio kits?
Contact us via “Contact Us” tab
- 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
- 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 800-288-4368 or 858-592-9300
General GenBio ImmunoDOT Product Questions:
- Is there something to HELP with interpretation and performance of ImmunoDOT tests?
There are “Interpretation Guides” available from GenBio with actual representative “reactions” in serial dilution through the cutoff. Attached is the text of that guide but for a fresh reaction strip, please contact GenBio Technical Services at 800-288-4368.
700-0104, ImmunoDOT Technical Guide
700-0417, ImmunoDOT Procedural Precautions
- Are there Material Safety Data Sheets available for ImmunoDOT tests?
700-0202, ImmunoDOT Material Safety Data Sheet
- What are the CPT codes currently used for reimbursement of GenBio tests?
700-0106, CPT Code Reference
- 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 considered in any quality control protocol in the lab.
700-0414, ImmunoDOT Quality Control
- 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
General GenBio ImmunoWELL Product Questions
- Are there Material Safety Data Sheets available for ImmunoWELL tests?
700-0200, ImmunoWELL Material Safety Data Sheet
- What are the “Most Frequently Overlooked” procedural precautions
when using the ImmunoWELL tests?
700-0410, ImmunoWELL Procedural Precautions
- What are the CPT codes currently used for reimbursement of GenBio tests?
700-0106, CPT Code Reference
- What about CMS interpretation guidelines?
700-0151, CMS Interpretation Guidelines
- Can any ImmunoWELL kit be run successfully on any “open” microtiter
system?
YES. We suggest you consult with GenBio technical services at 800-288-4368 or 858-592-9300 for “validation” protocol suggestions to satisfy your regulatory requirements.
- Are there special considerations as far as “negative controls”
provided with the ImmunoWELL kits?
700-0470, ImmunoWELL Negative Control
Epstein - Barr virus and MONO-like Syndrome:
ImmunoDOT MONO- 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
- What do all of the Epstein-Barr Parameters mean?
700-0491, EBV Primer
RA-0023, Manual of Clinical Immunology, Chapter 85
- 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
- Can you describe the nature of the antigens used in the ImmunoDOT MONO
tests?
700-0472, ImmunoDOT MONO G and MONO M antigens
- Why do you need to test for CMV when considering MONO-like syndrome?
RA-0021, Lajo, Pediatric Infectious Disease Journal, January 1994
- Why is the quality control of GenBio kits better than most other kits available
for EBV?
700-0498, EBV Quality Control
- What is the suggestion for proficiency testing with the MONO G and MONO
M kits?
700-0496, MONO G / MONO M Panels: Proficiency Testing
- 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
- Why is the quality control of GenBio kits better than most other kits
available?
700-0498, EBV Serology Quality Control
- What antigens are used in ImmunoWELL EBV tests?
700-0471, ImmunoWELL EBV Antigens
- 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
- 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
- What tests are considered when one considers EBV reactivation?
700-0488, EBV Serology Reactivation Assessment
Mycoplasma
- How does ImmunoWELL Mycoplasma IgM kit compare to complement fixation
“gold standard” testing done by the public health laboratories
for so many years?
700-0476, Ortega, 94th General Meeting of the ASM
- How does the 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
- Has the ImmunoWELL Mycoplasma IgM kit been tested with pediatric specimens
in a pediatric hospital?
RA-0005, Cimolai, American Journal of Clinical Pathology, February 1996
- What antigen is used for both the ImmunoWELL IgM and the ImmunoWELL IgG
test kits and why does it correlate so well with public health reference methods?
700-0406, ImmunoWELL Mycoplasma Antigen
- Since so many people have IgG antibodies to Mycoplasma sp., how does
the ImmunoWELL Mycoplasma IgG test perform on that “normal” population
as an aid to my using the test?
700-0489, ImmunoWELL Mycoplasma IgG Clinical Cutoff
Borrelia
ImmunoDOT Borrelia / ImmunoDOT DotBlot Borrelia- What is the difference between the ImmunoDOT Borrelia and the ImmunoDOT
DotBlot Borrelia IgM and Borrelia IgG?
Borrelia testing has gone through various generations as better technology has become available. GenBio maintains the last two generations of testing since the ImmunoDOT Borrelia test uses a polyvalent conjugate and the DotBlot Borrelia (the newer generation tests) offer IgG specific and IgM specific results. Some laboratories prefer a polyvalent conjugate. GenBio maintains CAP performance files for both tests and both tests are manufactured according to the strictest standards.
700-0116, ImmunoDOT Borrelia CAP Correlation
700-0117, CAP Proficiency Results, DotBlot Borrelia
- How well does the ImmunoDOT Borrelia polyvalent conjugate kit perform?
700-0514, Specific Performance for ImmunoDOT Borrelia (Lyme)
- How well do the ImmunoDOT DotBlot Borrelia IgG and IgM perform?
700-0614, Specific Performance for ImmunoDOT DotBlot Borrelia
RA-0010, Fawcett, Clinical and Diagnostic Immunology, July 1988
RA-0002, Brinkman, 96th General Meeting of the ASM
RA-0003, Brinkman, VII International Lyme Congress
700-0117, CAP DotBlot Borrelia IgG and IgM performance
700-0524, Specific Performance for the ImmunoDOT Borrelia DotBlot G and M
- What are the recombinant antigens used for the Borrelia DotBlot tests?
700-0497, ImmunoDOT Borrelia Antigens
- How well does the ImmunoDOT DotBlot Borrelia IgG and IgM perform versus
the combination of “screening” AND “western blot ‘supplemental’
testing (there is no “confirmation” test cleared by FDA) given
the need for “specificity”?
RA-0010, Fawcett, Clinical and Diagnostic Immunology, July 1988
RA-0038, Wormser, JAMA, July 1999
RA-0004, Brown, JAMA, July 1999 - What are the advantages of using a “recombinant protein” technology
like DotBlot Borrelia over using the old western blot technique (a supplemental,
not a confirmatory method for Borrelia)?
RA-0010, Fawcett, Clinical and Diagnostic Immunology, July 1988
- In 1994, before DotBlot was submitted to the FDA, CDC created a recommendation
for “supplemental testing of Borrelia” in order to improve EIA
and western blot accuracy. What was that old recommendation for “supplemental”
testing?
700-0493, DotBlot Borrelia Two-Tier Replacement or Adjunct Test
- Isn’t there a CDC Panel for Borrelia? How do the GenBio kits perform
on that CDC panel?
700-0110, CDC Borrelia Panel Evaluation
- How well does the ImmunoDOT DotBlot Borrelia IgG and IgM perform on “Pediatric”
specimens?
RA-0011, Fawcett, Clinical and Diagnostic Immunology, January 1997
- Has anyone tested patients “vaccinated” with the Borrelia vaccines
on the DotBlot Borrelia kits to see if they give “false positives”?
RA-0009, Fawcett, American College of Rheumatologists, 63rd Meeting
700-0482, DotBlot Borrelia, Testing Vaccinated Subjects
- 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
- How well does ImmunoWELL Borrelia test function as a “higher volume”
screening test?
700-0110, CDC Borrelia Panel Evaluation
- How well does the ImmunoWELL Borrelia kit perform?
700-0501, Specific Performance for the ImmunoWELL Borrelia test
- 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
- What about testing of Cerebral Spinal Fluids for the presence of Borrelial
antibodies?
700-0300, Borrelia CSF Protocol
- What about borderline results with the ImmunoWELL Borrelia kits?
700-0454, ImmunoWELL Borrelia (Lyme) Borderline
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
- Why is genital herpes a “global public health problem”?
RA-0001, Ballard, http://www.mediscover.net
- 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
- What about the use of IgM testing for Herpes Simplex Virus?
RA-0026, Page, Sexually Transmitted Infections, January 2003
- there any treatment for Genital Herpes?
www.valtrex.com
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
- How well does the ImmunoDOT TORCH test perform?
700-0515, ImmunoDOT TORCH Test Performance Studies
700-0460, ImmunoDOT TORCH Antibody Test
- 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
- What antigens are used in the ImmunoDOT TORCH test?
700-0419, ImmunoDOT TORCH Antigens
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
- What are the CPT reimbursement codes for the different ImmunoDOT autoimmune
panels?
700-0106, CPT Code Reference
- 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
- Why are patterns not important since the advent of “specific”
antibody tests to detect clinically relevant autoantibodies?
RA-0024, Muro, Autoimmunity, February 2005
- 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. If one uses a “more specific” test for relevant antibodies set to “clinical cutoffs” then the titer is irrelevant.
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
- 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?
RA-0034, Smeenk, Molecular Biology Reports, 1992.
- 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
- 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
- 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
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
- 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
- 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
- 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
Cardiolipin Antibodies
- Can someone explain the relevance of Cardiolipin antibodies in a patient?
RA-0029, Reddel, Clinical and Diagnostic Laboratory Immunology, November 1999
- 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 - Why does the ImmunoWELL Cardiolipin antibody test answer the need for
considering the antigens used in the testing
700-0099, ImmunoWELL Cardiolipin
