Test directory: Strep pneumoniae Ab IgG 14 Serotype

Ordering Code8025
Test NameStrep pneumoniae Ab IgG 14 Serotype
AliasStreptococcus pneumoniae Antibodies, IgG (14 Serotypes)
Pneumococcal Antibodies
Preferred SpecimenSerum
Preferred ContainerSST (Gold)
Other Specimen/ContainerSerum in Plain (Red)
Optimum Volume1.5 mL
Collection InstructionsPostimmunization specimen should be drawn 30 days after immunization and, if shipped separately, must be received within 60 days of preimmunization specimen.
Handling InstructionsSeparate serum promptly
If applicable, mark specimens clearly as "PRE" or "POST" so specimens will be saved and tested simultaneously.
Transport RequirementsOahu: Ambient
Airline: Refrigerated
Specimen StabilityAmbient: 2 Days
Refrigerated: 2 Weeks
Frozen: 2 Months
Stability applies ONLY to serum aliquots.
Rejection CriteriaHemolyzed, Plasma, Contaminated or severely lipemic specimens
Avail. StatNO
Analytic Time7 Days
MethodologyQuantitative Multiplex Chemiluminescent Immunoassay
Reference Lab ARUP Laboratories

Reference range(s)

The reference ranges listed below are valid on this date of September 16, 2024.
ComponentAgeMale NormMale Critical LowMale Critical HighFemale NormFemale Critical HighFemale Critical LowUnitsAdd'l info
Pn serotype 1 IgGALLug/mL
(P13,P20,PNX,V15) ... (P13,P20,PNX,V15)
See report.
Note1
Pn serotype 3 IgGALLug/mL
(P13,P20,PNX,V15) ... (P13,P20,PNX,V15)
See report.
Note1
Pn serotype 4 IgGALLug/mL
(P7,P13,P20,PNX,V15... (P7,P13,P20,PNX,V15)
See report.
Note2
Pn serotype 5 IgGALLug/mL
(P13,P20,PNX,V15) ... (P13,P20,PNX,V15)
See report.
Note1
Pn serotype 6B IgGALLug/mL
(P7,P13,P20,PNX,V15... (P7,P13,P20,PNX,V15)
See report.
Note2
Pn serotype 7F IgGALLug/mL
(P13,P20,PNX,V15) ... (P13,P20,PNX,V15)
See report.
Note1
Pn serotype 8 IgGALLug/mL
(P20,PNX)
See... (P20,PNX)
See report.
Note3
Pn serotype 9N IgGALLug/mL
(PNX)
See... (PNX)
See report.
Note4
Pn serotype 9V IgGALLug/mL
(P7,P13,P20,PNX,V15... (P7,P13,P20,PNX,V15)
See report.
Note2
Pn serotype 12F IgGALLug/mL
(P20,PNX)
See... (P20,PNX)
See report.
Note3
Pn serotype 14 IgGALLug/mL
(P7,P13,P20,PNX,V15... (P7,P13,P20,PNX,V15)
See report.
Note2
Pn serotype 18C IgGALLug/mL
(P7,P13,P20,PNX,V15... (P7,P13,P20,PNX,V15)
See report.
Note2
Pn serotype 19F IgGALLug/mL
(P7,P13,P20,PNX,V15... (P7,P13,P20,PNX,V15)
See report.
Note2
Pn serotype 23F IgGALLug/mL
(P7,P13,P20,PNX,V15... (P7,P13,P20,PNX,V15)
See report.
Note2
InterpretationALL

Interpretive...
Interpretive Information:
A pre- and postvaccination comparison is required to
adequately assess the humoral immune response to the
pure polysaccharide Pneumovax 23 (PNX) and/or the
protein conjugated Prevnar 7 (P7), Prevnar 13 (P13),
Prevnar 20 (P20), and Vaxneuvance (V15) Streptococcus
pneumoniae vaccines. Prevaccination samples should
be collected prior to vaccine administration.
Postvaccination samples should be obtained at least
4 weeks after immunization. Testing of
postvaccination samples alone will provide only
general immune status of the individual to various
pneumococcal serotypes.
 
In the case of pure polysaccharide vaccine,
indication of immune system competence is further
delineated as an adequate response to at least
50 percent of the serotypes in the vaccine challenge
for those 2-5 years of age and to at least 70
percent of the serotypes in the vaccine challenge
for those 6-65 years of age. Individual immune
response may vary based on age, past exposure,
immunocompetence, and pneumococcal serotype.
 
Responder Status                   Antibody Ratio
Nonresponder ..................... Less than twofold
                                   increase and post
                                   vaccination
                                   concentration less
                                   than 1.3 ug/mL
 
Good responder ................... At least a twofold
                                   increase and/or a
                                   postvaccination
                                   concentration
                                   greater than or
                                   equal to 1.3 ug/mL
 
A response to 50-70 percent or more of the serotypes
in the vaccine challenge is considered a normal
humoral response. (Daly, 2014) Antibody concentration
greater than 1.0-1.3 ug/mL is generally considered
long-term protection. (Daly, 2015)
 
References:
1. Daly TM, Pickering JW, Zhang X, et al.
Multilaboratory assessment of threshold versus
fold-change algorithms for minimizing analytical
variability in multiplexed pneumococcal IgG
measurements. Clin Vaccine Immunol.
2014;21(7):982-988.
 
2. Daly TM, Hill HR. Use and clinical interpretation
of pneumococcal antibody measurements in the
evaluation of humoral immune function. Clin Vaccine
Immunol. 2015;22(2):148-152.
 
This test was developed and its performance
characteristics determined by ARUP Laboratories. It
has not been cleared or approved by the U.S. Food
and Drug Administration. This test was performed in
a CLIA-certified laboratory and is intended for
clinical purposes.

See report.
Note5

Note1:

(P13,P20,PNX,V15)
See report..

Note2:

(P7,P13,P20,PNX,V15)
See report..

Note3:

(P20,PNX)
See report..

Note4:

(PNX)
See report..

Note5:


Interpretive Information:
A pre- and postvaccination comparison is required to
adequately assess the humoral immune response to the
pure polysaccharide Pneumovax 23 (PNX) and/or the
protein conjugated Prevnar 7 (P7), Prevnar 13 (P13),
Prevnar 20 (P20), and Vaxneuvance (V15) Streptococcus
pneumoniae vaccines. Prevaccination samples should
be collected prior to vaccine administration.
Postvaccination samples should be obtained at least
4 weeks after immunization. Testing of
postvaccination samples alone will provide only
general immune status of the individual to various
pneumococcal serotypes.
 
In the case of pure polysaccharide vaccine,
indication of immune system competence is further
delineated as an adequate response to at least
50 percent of the serotypes in the vaccine challenge
for those 2-5 years of age and to at least 70
percent of the serotypes in the vaccine challenge
for those 6-65 years of age. Individual immune
response may vary based on age, past exposure,
immunocompetence, and pneumococcal serotype.
 
Responder Status                   Antibody Ratio
Nonresponder ..................... Less than twofold
                                   increase and post
                                   vaccination
                                   concentration less
                                   than 1.3 ug/mL
 
Good responder ................... At least a twofold
                                   increase and/or a
                                   postvaccination
                                   concentration
                                   greater than or
                                   equal to 1.3 ug/mL
 
A response to 50-70 percent or more of the serotypes
in the vaccine challenge is considered a normal
humoral response. (Daly, 2014) Antibody concentration
greater than 1.0-1.3 ug/mL is generally considered
long-term protection. (Daly, 2015)
 
References:
1. Daly TM, Pickering JW, Zhang X, et al.
Multilaboratory assessment of threshold versus
fold-change algorithms for minimizing analytical
variability in multiplexed pneumococcal IgG
measurements. Clin Vaccine Immunol.
2014;21(7):982-988.
 
2. Daly TM, Hill HR. Use and clinical interpretation
of pneumococcal antibody measurements in the
evaluation of humoral immune function. Clin Vaccine
Immunol. 2015;22(2):148-152.
 
This test was developed and its performance
characteristics determined by ARUP Laboratories. It
has not been cleared or approved by the U.S. Food
and Drug Administration. This test was performed in
a CLIA-certified laboratory and is intended for
clinical purposes.

See report..