Immunology/Serology

Previous Next

Immunology/Serology


ANTINUCLEAR ANTIBODY

Five liquid serum specimens per testing event, 0.6 mL for the following analytes:


Antinuclear Antibody Screen

Anti-dsDNA

Anti-RNP

Anti-RNP/SM

Anti-SSB

Florescence Pattern

Anti-ssDNA

Anti-SM

Anti-SSA

Anti-SSA/AAB


Participants may report results from any of the four types of screening methods: classical (IEA/IFA), anti-DNP (LA) or anti-ENA (EIA) or Algorithm based; but they must not report results from more than one screening method in the same testing event. Code either the absence or presence of antinuclear antibody, using either code 10 for negative (or for normal patterns in the case of IEA/IFA methods) or code 11 for positive (... for positive or for abnormal patterns in the case of IEA/IFA methods). Code the method used by entering the appropriate numeric code from the corresponding list on the reporting form.

For CLIA purposes, you must report all five samples for one of the screening methods.


Report IFA patterns and individual antibodies on the appropriate reporting line, including the method code where applicable.


ANTISTREPTOLYSIN O

Five liquid serum specimens per testing event, 1.0 mL

Code your qualitative answers using only the codes provided on the “Antistreptolysin O” line of the Diagnostic Immunology reporting form and code the method used by entering the appropriate numeric code from the list on the form.


C-REACTIVE PROTEIN

Two liquid serum specimens per testing event, 0.5 mL

Code your qualitative answers using only the codes provided on the “C-Reactive Protein qualitative” line of the Diagnostic Immunology reporting form and code the method used by entering the appropriate numeric code from the list on the form. Quantitative results are to be entered on the subsequent line.


HELICOBACTER PYLORI ANTIBODY

Two liquid serum specimens per testing event, 0.5 mL

These specimens are also designed to work with whole blood methods, but participants must use their method’s collection tubes just as they would for testing patients. Fill the collection tube directly from the specimen vial, then follow your routine testing protocol. Code your qualitative answers as either 10 for negative or 11 for positive and code the method used by entering the appropriate numeric code from the list on the form.


HEPATITIS MARKERS

Five liquid serum specimens per testing event, 1.5 mL, for the following analytes:


Anti-HBc (IgG+IgM or IgM)

Anti-HCV

HBeAg

Anti-HBs

Anti-Hepatitis A

HBsAg


Code your qualitative answers only with the result codes on each line of the reporting form and code your methods using the reagent codes included on the form.


If your method is immunoglobulin (Ig)-nonspecific or its specificity is not known, report results on the IgG line.

Roche Elecsys Anti‐HCV

Based on the reagent package insert for the anti‐HCV test performed on the Roche Cobas Elecsys, those participants reporting this test in our Hepatitis Markers proficiency testing program using method code 826 can report the result code “15 Would Refer” for specimens with COI between 1.00 and 149.99.  You must add a comment to your report form stating that the COI fell within that range when reporting that result code.  You must retain your instrument printout in your records for reference when audited.

Ref: Roche Diagnostics Anti‐HCV document 05587166001V4, page 3/10


Special Safety Precautions-These specimens should be handled as though they are capable of transmitting disease. Follow CDC and FDA recommendations as well as the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175-64182).


These specimens should be handled in a biological safety cabinet while wearing impermeable gloves. Remove the specimens from the can using forceps that are long enough to avoid cutting or scratching your hands on the can. Cover the caps of the vials with gauze while removing or replacing to prevent splashing. Do not pipet by mouth or use a needle and syringe with these specimens. Wash your hands after removing the gloves. These specimens should be autoclaved and disposed of as biohazardous waste.


HIV MARKERS, Rapid, Waived

Two liquid samples, 1.0 mL for waived methods only for the following analytes:


Anti-HIV-1 Screening

HIV p24 Antigen


For rapid testing or oral fluid methods using waived methods.  For oral fluid methods, inoculate the samples to the specimen collection and transport device before testing.

HIV ANTIBODIES, ORAL FLUID

Five liquid samples per testing event, 1.0 mL.


Anti-HIV-1 Screening

Anti-HIV-1 Confirmation


Inoculate the samples to the specimen collection and transport device before testing. Western Blot may be performed on these specimens. The presence of any band along the prerequisite bands should be interpreted as positive.


HIV MARKERS

Five liquid serum specimens per testing event, 1.0 mL, for the following analytes:


Anti-HIV-1 Screening

Anti-HIV-1 Confirmation

HIV p24 Antigen


These specimens are compatible for serum, plasma or whole blood methods.


Code your qualitative answers only with the result codes on each line of the reporting form and code your methods using the reagent codes included on the form.


To avoid false positive results, participants using membrane-based methods must centrifuge specimens prior to testing.


Screening and/or confirmatory results may be reported for anti-HIV-1, but only one method can be used for CMS subspecialty scoring in general immunology, the one pre-designated as such by participants, which, according to CMS, should be your routine (highest volume) method. Since scoring discrepancies may occur between methods, ensure that you report all five results for any of these HIV markers from the same method, whether your routine method is a screening method or a confirmatory method.

Important Information - If your laboratory offers both screening and confirmatory testing for HIV, then you may choose to report either the EIA or western blot results to meet regulatory requirements.

Those who report confirmatory (rather than their screening) anti-HIV results that may not routinely perform confirmatory testing on patient specimens which are negative on initial screen, per CMS requirements must report results on all five HIV Marker specimens to avoid being penalized for missing results. If you do not routinely perform confirmatory testing on negative specimens, please use the result code indicating that this is the case.


NOTE:  4th Generation HIV antigen/antibody combination kit users must indicate an established method code or alert us to the fact that their method is antigen/antibody combination kit so that we may peer group your results appropriately.


Special Safety Precautions-Specimens testing positive for anti- HIV have been heat treated. Even so, all these specimens should be handled as though they are capable of transmitting disease. Follow CDC and FDA recommendations as well as the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175-64182). These specimens should be handled in a biological safety cabinet while wearing impermeable gloves.


Remove the specimens from the can using forceps that are long enough to avoid cutting or scratching your hands on the can. Cover the caps of the vials with gauze while removing or replacing to prevent splashing. Do not pipet by mouth or use a needle and syringe with these specimens. Wash your hands after removing the gloves. These specimens should be autoclaved and disposed of as biohazardous waste.


IMMUNOPROTEINS

Five liquid serum specimens per testing event, 1.0 mL, for the following analytes:


C3

C4

IgA

IgE

IgG

IgM


Where appropriate, all participants must report results which are calibrated against the International Federation of Clinical Chemistry (IFCC)’s Reference Preparation for Proteins in Human Serum (RPPHS). Code the method(s) used by entering the appropriate numeric codes from the list(s) on the form.


LYME DISEASE

Two liquid serum specimens per testing event, 0.6 mL

Important Information  ‐  If your laboratory offers both screening and confirmatory testing for Lyme disease then you may choose to report either the EIA or western blot results to meet regulatory requirements.


If you choose to report your screening results, then you may select “Negative specimens not tested” in accordance with your laboratory’s procedures for confirmatory testing where applicable.  If you choose to report your confirmatory results to meet the regulatory requirements then you must report testing result for all five specimens in order to satisfy the CLIA requirement that you test five samples per proficiency event.


Be careful to enter results on the proper line (lines are provided for both screening and immunoblot results). Code your qualitative answers as either 10 for negative or 11 for positive and code the method used by entering the appropriate numeric code from the list on the form.


MONONUCLEOSIS, INFECTIOUS, WAIVED

Two liquid serum specimens per testing event, 0.65 mL


MONONUCLEOSIS, INFECTIOUS, 5-VIAL

Five liquid serum specimens per testing event, 0.65 mL


These specimens are for infectious mononucleosis (IgG or IgM) procedures. Code your qualitative answers using only the codes provided on the “Infectious Mononucleosis” line of the Diagnostic Immunology reporting form and code the method used by entering the appropriate numeric code from the list on the form.


MYCOPLASMA ANTIBODY

Two lyophilized samples per testing event, 0.5 mL

Reconstitute these specimens as follows:

1.        Add 0.5 mL reagent grade water.

2.        Invert occasionally until completely dissolved (do not shake).

3.        Let stand for 15 minutes after dissolution.

4.        Invert again prior to sampling.


These specimens are for Mycoplasma IgG/IgM antibody procedures. Code your qualitative answers using only the codes provided on the reporting form and code the method used by entering the appropriate numeric code from the list on the form.


RHEUMATOID FACTOR

Five liquid serum specimens per testing event, 1.0 mL


These specimens are for qualitative or quantitative rheumatoid factor (IgG or IgM) procedures. Code your qualitative answers using only the codes provided on the “Rheumatoid Factor” line of the Diagnostic Immunology reporting form. For quantitative methods, report your results on the subsequent line.


Code the method used by entering the appropriate numeric code from the list on the form. Follow the manufacturer’s instructions for the pretreatment of serum specimens just as you would for any patient specimen.


RUBELLA

Five liquid serum specimens per testing event, 1.0 mL


Code your answers as either 10 (not immune or negative) or 11 (immune or positive). If using a quantitative method, use the upper cutoff value of your normal range to distinguish not immune from immune status.

Code the method used by entering the appropriate code from the list provided on the form.


SYPHILIS SEROLOGY

Five liquid serum specimens per testing event, 1.0 mL


Code your answers using only the codes listed on the line of the reporting form which is appropriate to the method used. Code the methods used by entering the appropriate codes from the list provided on the form.


Separate lines are provided to accommodate participants’ results from more than one method. Procedures for which results are preformatted includes RPR Card, RST, TRUST, VDRL, USR, FTA-ABS, FTA-ABS DS, MHA-TP/TP-PA, and EIA, but only one method can be used for CMS subspecialty scoring in syphilis serology, the one pre-designated as such by participants. Do not attempt to use the same line to report results from more than one procedure.


Participants who request that we report their confirmatory (rather than their screening) syphilis results to the regulatory authorities, even those who may not routinely perform confirmatory testing on patient specimens which are negative on a screening procedure, should report results on all five Syphilis specimens to avoid being penalized for missing results.

Important Information ‐ If your laboratory offers both screening and confirmatory testing for Syphilis, then you may choose to report either the EIA or western blot results to meet regulatory requirements.


If you choose to report your screening results, then you may select “Negative specimens not tested” in accordance with your laboratory’s procedure.  If you choose to report your confirmatory results to meet the regulatory requirements then you must report testing result for all five specimens in order to satisfy the CLIA requirement that you test five samples per proficiency event.


ToRCH Test

Three liquid samples per testing event, 2 testing events per year, 1.0 mL.


Cytomegalovirus

HSV1 IgG/IgM

HSV2 IgG/IgM

Rubella IgM

Toxoplasma


Note:  This program is a Rubella IgM supplemental program only.  For CLIA reporting purposes you must enroll in and report the regular Rubella program.


Sample is 1.0 mL of serum, mix by gentle inversion before testing.  Samples should be tested the same as patient specimens.


For methods that do not differentiate between HSV I and HSV II, please enter results under HSV II results using result code "714" for positives.  For methods that are Ig non‐specific, report results as IgG using result code "715" for positives.


These specimens should be handled as though they are capable of transmitting disease.  Follow CDC and FDA recommendations as well as the Occupational Safety and Health Administration (OSHA) Final Rule on Occupational Exposure to Bloodborne Pathogens published December 6, 1991 (Federal Register Volume 56, Number 235, pages 64175‐64182).  Do not pipet by mouth or use a needle and syringe with these specimens.  Wash your hands after removing the gloves.  These specimens should be autoclaved or disposed of as hazardous waste.


These specimens will only be included in the first and third event shipments.