#1140187
Quidel #M311

Other Infectious Disease Test Kit Solana® Group B Strep Group B Streptococcus 48 Tests CLIA Non-Waived

Name: Other Infectious Disease Test Kit
Brand: Solana® Group B Strep

TEST KIT, STREP ASSAY SOLANA GROUP B (48/KT) D/S

Other Infectious Disease Test Kit Solana® Group B Strep Group B Streptococcus 48 Tests CLIA Non-Waived

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Product Specifications

McKesson #

1140187

Manufacturer #

M311

Brand

Solana® Group B Strep

Manufacturer

Quidel

Country of Origin

United States

Application

Other Infectious Disease Test Kit

CLIA Classification

CLIA Moderate Complexity

CLIA Classified

CLIA Non-Waived

Contents 1

48 Tests per Kit, Process Buffer (48 Tubes per Kit), Reaction Tubes (48 Tubes per Kit

Is_ECAT

Is_GSA

Is_VA

Number of Tests

48 Tests

Product Dating

McKesson Acceptable Dating: we will ship >= 90 days

Purchase Program Type

Standard Purchase

Reading Type

Machine Read

Sample Type

Vaginal Secretion / Rectal Swab Sample

Specialty

Molecular

Storage Requirements

Requires Refrigeration

Test Format

Cassette Format

Test Kit Type

Standard

Test Method

Helicase-dependent Amplification

Test Name

Group B Streptococcus

Test Type

Molecular Diagnostic

Time to Results

30 Minute Results

UNSPSC Code

41116129

Features

The Solana GBS Assay is an in vitro diagnostic test for the direct, qualitative detection of Group B Streptococcus from vaginal/rectal swabs following 18 to 24 hours incubation in LIM or Carrot broth cultures
The assay utilizes helicase-dependent amplification (HDA) for the amplification of a highly conserved fragment of the Thiolase (atoB) gene sequence and is intended for use only with the Solana instrument
An overnight LIM or Carrot broth culture enriched from a swab is lysed by simple heat treatment, aliquoted and added to a Reaction Tube containing lyophilized mix of HDA reagents including primers specific for the amplification of a fragment from the conserved region of the Thiolase (atoB) DNA
Results are displayed on the touchscreen, can be saved to the instrument, printed, and are capable of being sent to the LIS and exported through one of Solana’s four USB ports