Macro-Vue™ Rapid Plasma Reagin Card Test Kit, No. 110, 500 Test

Macro-Vue™ Rapid Plasma Reagin Card Test Kit, No. 110 (500 Tests)

The Macro-Vue™ Rapid Plasma Reagin (RPR) Card Test Kit, No. 110, is a qualitative and semi-quantitative nontreponemal serologic test kit designed for use by trained laboratory personnel to aid in the detection of reagin antibodies associated with syphilis. This card-based flocculation assay is intended for in vitro diagnostic use with appropriate patient specimens and standard laboratory practices. The 500-test configuration supports higher-volume screening and follow-up testing in clinical laboratories and public health settings.

Intended Use

This RPR card test is used as a screening method and, when performed with serial dilutions, may provide semi-quantitative information (reported as a titer) useful for patient management and monitoring response to therapy. As a nontreponemal assay, results must be interpreted in conjunction with clinical findings, patient history, and other laboratory tests. Reactive results should be confirmed using a treponemal-specific test, as recommended by applicable guidelines.

Key Features

• Rapid card format supporting efficient workflow for routine screening.
• Macroscopic readout designed for clear visualization of flocculation patterns.
• Qualitative and semi-quantitative capability when performed according to the instructions for use.
• 500-test kit size suited to medium-to-high throughput laboratories.
• Standardized reagents intended to support consistent performance when proper technique and quality control are applied.

Kit Components

Contents vary by configuration and may include antigen suspension, test cards, disposable dispensing or mixing items, and instructions for use. Laboratories should verify the exact contents upon receipt and use only the materials supplied or specified as compatible by the manufacturer.

Principle of the Test

The RPR card test is based on a flocculation reaction between reagin antibodies in patient specimens and a cardiolipin-containing antigen. When reactive antibodies are present, visible clumping may occur under specified rotation and timing conditions. Nonreactive specimens typically remain uniformly suspended without characteristic clumping.

General Workflow Overview

1. Bring reagents and specimens to the recommended temperature and mix as directed.
2. Place the required volume of specimen onto the designated test circle.
3. Add antigen using the specified delivery method and mix per instructions.
4. Rotate for the required time and read results immediately under appropriate lighting.
5. For semi-quantitative testing, perform serial dilutions and report the highest reactive dilution as the titer.

Quality Control

Run appropriate controls according to the instructions for use and your laboratory quality system. Control results must meet acceptance criteria before reporting patient results. Document lot numbers, expiration dates, and QC outcomes for traceability.

Specimen, Storage, and Handling

Use only specimen types listed in the instructions for use. Store kit components under the recommended conditions, protect reagents from contamination, and do not use materials beyond expiration. Follow biosafety precautions for handling human specimens, as all samples should be considered potentially infectious.

Limitations

Nontreponemal tests may yield biological false reactive or false nonreactive results. Early infection, late-stage disease, prior treatment, and other medical conditions can affect results. This test is not intended as the sole basis for diagnosis.