Abbott ARCHITECT Syphilis TP Assay Product Leaflet

The Abbott ARCHITECT Syphilis TP assay is a qualitative chemiluminescent microparticle immunoassay for detecting Treponema pallidum antibodies in serum and…


Abbott ARCHITECT Syphilis TP Assay Product Leaflet - cover page
Brand
Abbott
Category
Health Care
Document type
Product Leaflet
Language
English
Pages
2
File format
PDF
File size
389 KB
Published
05 October, 2026
Updated
05 October, 2026
MD5 checksum
69539787D315B22BFA8886DDE7B7D679

About this manual

The ARCHITECT Syphilis TP assay is a qualitative CMIA used to detect IgG and IgM antibodies against Treponema pallidum in human serum and plasma. It can be employed as an initial diagnostic test or in conjunction with a nontreponemal test to aid syphilis diagnosis.\n\nKey features include automated testing that reduces manual RPR labor, objective result interpretation, and a three‑antigen (Tp15, Tp17, Tp47) microparticle format. The assay delivers up to 200 results per hour with a first‑result time of 29 minutes, and reagents remain stable for 30 days on‑board.

What's inside

  • BACKGROUND
  • INTENDED USE AND IMPORTANT SAFETY INFORMATION
  • PRODUCT DESCRIPTION
  • METHOD & FORMAT
  • THROUGHPUT / TIME TO FIRST RESULT
  • REAGENT ON-BOARD / CALIBRATION STABILITY
  • INTERPRETATION OF RESULTS
  • SAMPLE VOLUME
  • SAMPLE TYPE
  • REFERENCES

Specifications

MethodTwo-step chemiluminescent microparticle immunoassay (CMIA)
ThroughputUp to 200 tests per hour
Time to first result29 minutes
Reagent stability (on‑board)30 days
Calibration stability30 days
Sample typeHuman serum and plasma
Result interpretation cutoffReactive ≥1.00, Nonreactive <1.00

Frequently asked questions

What is the intended use of the ARCHITECT Syphilis TP assay?

It is a qualitative chemiluminescent microparticle immunoassay for detecting IgG and IgM antibodies against Treponema pallidum in human serum and plasma, used as an initial diagnostic test or together with a nontreponemal test.

How many tests can the system run per hour with this assay?

The system can process up to 200 tests per hour.

What sample volume is required for a single test?

A single test requires 150 µL of serum or plasma.

What are the result interpretation cutoffs for this assay?

Results are reactive when the signal is ≥1.00 and nonreactive when it is <1.00.

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