BOSCH STI Test Sexually Transmitted Infections Instruction Manual

: June 3, 2024
: Bosch

Table of Contents

BOSCH STI Test Sexually Transmitted Infections
Package Contents
Safety Information
Intended Use
Performance Data
Bosch Healthcare Solutions GmbH
References
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Download This Manual (PDF format)

BOSCH STI Test Sexually Transmitted Infections

BOSCH-STI-Test -Transmitted-Infections-PRODUCT

Package Contents

15 Vivalytic STI test cartridges for detection of sexually transmitted infections (STI)

Safety Information

These instructions for use contain test-specific information only. For additional warnings and instructions refer to the instructions for use provided with your Vivalytic analyser (chapter device safety information). Only use Vivalytic cartridges and accessories approved for the analyser. Make sure to insert samples properly. Remove spilled samples with a cloth soaked with the appropriate solution. You can use 70 % ethanol. If you need to disinfect the cartridge by spraying (for example after heavy spillage of sample) do not use the cartridge afterwards since it might be damaged by disinfectant.

WARNING

Do not use a cartridge if the sealed pouch or the cartridge itself is visibly damaged.
Do not touch or scratch the detection area of the cartridge.
Do not reuse a cartridge.
Do not use expired cartridges. The expiration date can be found on the packaging and the cartridge label.
Do not wait longer than 15 minutes after opening the cartridge pouch to begin the test. This maintains hygiene and avoids performance loss due to humidity. Prolonged exposure to humidity has a negative impact on test performance.
Do not use sample types, media and volumes that are not approved for the test application.
Do not shake a cartridge that contains a sample.
Do not turn the cartridge upside down.
Handle potentially infectious patient samples according to laboratory standards and dispose samples according to regional and laboratory standards. Make sure to wear appropriate personal protective equipment (PPE).
Place the cartridge on a clean surface.
Be compliant with the national safety regulations and practices.

Additional Equipment required but not provided
Bosch Vivalytic one Analyser pipette (1000 μl)

Intended Use

The Bosch Vivalytic STI test is a qualitative PCR-based assay for simultaneous detection of 10 common sexually transmitted pathogens (table 1) from either urine samples or urogenital swabs to aid in the diagnosis of sexually transmitted infections from both symptomatic and asymptomatic patients. Configured for use with a Vivalytic analyzer.

Sample Type/Medium

This test is validated with urine samples in eNAT™ medium (COPAN Italia S.P.A.) and in Roche cobas® PCR medium, with swabs in eNAT™ medium (COPAN Italia S.P.A.), in Roche cobas® PCR medium and in phosphate buffered saline solution (PBS) as well as with exudates in Roche cobas® PCR medium. Collect and store samples as indicated in the manufacturer’s data sheet.

Sample Preparation

Shake the sample tube containing the urine or swab sample and the liquid medium for homogenization and fill 300 μl of homogenized patient sample in the sample input of the cartridge. Do not use viscous samples that are difficult to pipette.

Test Result

The test result (list of positively/negatively detected pathogens) is shown on the screen. For further information, you are guided through different levels of detail by the software. The microarray data level shows a software-modified and normalized picture of the microarray with the immobilized target-specific DNA probes.

In case of a valid test, the internal controls for a successful extraction, amplification and conjugation can be viewed in the tab control. In the absence of the extraction/amplification control, the test is automatically rated as invalid. In the absence of the conjugation control, the microarray cannot be evaluated, and the test is rated as failed. In the printed test report, all pathogens, results and information on user, patient and analyser are listed with a signature field. Controls are not listed in detail. A valid test corresponds to successful extraction, amplification andconjugation. In case of an invalid test, check if any notices are displayed after the run. Possible reasons for an invalid run might be poor sample quality or no DNA. Repeat the analysis with a new aliquot of the same sample if required. Pay attention to use the correct sample type, the right sample collection and storage of the sample and cartridges prior to the test run. The test is shown as invalid if not enough human cells are present in the sample (extraction/amplification control). Detected pathogens are displayed for an invalid test. In case of a failed test, first check for correct operating conditions of the analyser (refer to analyser‘s instructions for use, chapters device safety information and technical data). Restart the analyser. If the problem persists, contact the customer service.

Quality Control

If required by your local or laboratory standards, quality control testing has to be performed. You can either use pre-characterized patient samples that were investigated by a reference testing method or purchase quality control materials. In case of unexpected results, repeat the analysis with another sample. If the result of a quality negative control sample remains positive, the analyser or its environment might be contaminated. Stop using the analyser and call the customer service. In case of repeated negative results for positive quality control samples, also call the customer service.

Limitations

The results of the Vivalytic STI test should be interpreted by a trained healthcare professional. The results of the Vivalytic STI test should not be used as the sole parameter for diagnosis.

A negative result does not exclude STI pathogens being present in the sample at a level below assay sensitivity or a pathogen that is not covered by this assay.
There is a risk of false negative values resulting from improperly collected, transported, or handled samples. Analytical Sensitivity (Limit of Detection, 95 % Detection rate) To define the LoD, concentrations of the target analytes were determined at a detection rate of 95 % (table 2). Each target was tested individually at different concentrations in a range close to the preliminary LoD.

Analytical Specificity (Inclusivity and Exclusivity)

To evaluate inclusivity, different target strains of various pathogens (table 3) with a total number of 100 DNA copies were evaluated. To exclude crossreactivity (exclusivity), phylogenetically related and non-related strains (table 4) were tested by using nucleic acids that were added at a concentration of 3×104 genome equivalents per testing.

Interferences

Interferences were evaluated for endogenous and exogenous substances(table 5) that are potentially present in the patient sample. No interferences were detected.

Sensitivity and Specificity

The results derived from patient samples (positive and negative samples) collected in a clinical setting were compared with those of a reference method (table 6). In addition, negative patient samples spiked with positive reference material were tested.