LABORATORY
AVERA SACRED HEART HOSPITAL
501 Summit • Yankton • SD 57078
668-8169
Technical Service Bulletin
12/11/2012
A new analyzer, Abbott Architect 1000i, has been installed at the Avera Sacred Heart Hospital laboratory.
This analyzer will allow us to offer two new assays, VITD-OH25 and HIV Antigen/ Antibody combo.
We will also be implementing a new B-Natriuretic Peptide (BNP) assay. The target go-live date for this testing is
scheduled for December 17, 2012.
The ARCHITECT 25-OH Vitamin D assay is to be used as an aid in the assessment of vitamin D sufficiency. It is
a chemiluminescent microparticle immunoassay (CMIA) method.
Sample type requirement is Serum (SST or RED) and Heparin (Lithium or Sodium)
Sample storage: 12 days at refrigerated temperature (2-8°C)
Measurement / Reportable range: 13.0 ng/mL to 96.0 ng/mL.
Specimen concentration > 96.0 ng/mL will be reported as “> 96.0 ng/mL”
Normal Reference Range: >30 ng/mL
The ARCHITECT HIV Ag/Ab Combo assay is a chemiluminescent microparticle immunoassay (CMIA) for the
simultaneous qualitative detection of human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV type
1 (HIV-1 group M and group O) and/or type 2 (HIV-2) in human serum and plasma (EDTA and heparin). The
ARCHITECT HIV Ag/Ab Combo assay is intended to be used as an aid in the diagnosis of HIV-1/HIV-2 infection,
including acute or primary HIV-1 infection. The assay may also be used as an aid in the diagnosis of HIV-1/HIV-2
infection in pediatric subjects (i.e., children as young as two years of age) and in pregnant women.
An ARCHITECT HIV Ag/Ab Combo reactive result does not distinguish between the detection of HIV-1 p24
antigen, HIV-1 antibody, or HIV-2 antibody.
Sample type requirements: Serum (SST or RED), EDTA plasma, or Heparin (Sodium or Lithium)
Sample storage: 7 days at refrigerated temperature (2-8°C)
The reported interpretation, Reactive or Non Reactive, is based on the calculated Signal to Cut off Ratio (S/CO). A
Non reactive sample has an S/CO ratio <1.00. Reactive results have an S/CO > 1.0. Reactive samples are tested in
triplicate before reporting “Reactive”. Refer to the attached HIV algorithm for diagnostic follow-up test
recommendations: HIV12 RX (ARUP 2005377) and/or HIV1 RNA QUANT by PCR (ARUP 55598)
The Architect BNP assay will be replacing the Abbott AxSym BNP assay. The AxSym system has been
discontinued by the manufacturer. There is no change in the sample requirements, sample storage nor the
normal Reference range, <100 pg/mL. I anticipate that you will see a faster turn-around time with the
new BNP assay.
Very respectfully,
Doris L Heilman MT (ASCP)
Automation Coordinator
cc. Richard Strom MD
ASHH Laboratory Medical Director
Physicians Laboratory, Ltd