How the spinit® instrument works
The spinit® instrument is a stand
-
alone, small benchtop
in vitro
medical device intended to deliver
a diagnostic platform designed to work with the spinit® discs.
The spinit® platform is based on a proprietary technology designed to offer rapid results from a
single drop of blood, providing fast, safe and effective clinical monitoring and improved patient
care. The instrument is designed to be a universal, multi
-
assay instrument platform capable of
accommodating different tests developed to address the most urgent needs in the clinic. The
barcode on the disc prompts the instrument to conduct the appropriate program.
Two versions of the spinit® instrument are currently CE marked.
The spinit® S40 is the complete version of the spinit® instrument and is designed to include all ana-
lytical modules enabling the customer to run all three types of spinit® tests currently available on
the market, the spinit® CRP (measures C
-
Reactive Protein levels in whole blood), spinit® HbA1c
(measures glycated haemoglobin A1c concentration in whole blood and BC (measures total white
blood cell count and 5
-
part differential).
The spinit® E40 is the Essential version of the spinit® instrument and only reads spinit® CRP and
spinit® HbA1c discs.
Both spinit® S40
’
s and E40´s analytical modules are comprised of a spectrophotometer. The spec-
trophotometer is made up of two light emitting diodes (LEDs), two photodiodes that function as
detectors and an electronic circuit board that processes the LEDs independently. Emitted light is
reflected inside the disc and passes through a detection chamber. Transmittance of light through
the optical path is measured and will vary depending on the reaction occurring inside the cham-
ber. The transmission of light through the blood sample in the detection chamber is measured and
is correlated to the concentration of the specific analyte. The instrument accepts several types of
spinit® discs. The analytical process is fully automated and the completed test results are shown
on the screen. In addition, only the S40 integrates a microscopy module for image acquisition and
a precise angular disc positioning module. The microscopy module is composed of the following
components: illumination stage, miniaturized microscope with auto
-
focus capability and a digital
camera.
Moreover the software version must include the following features: remote control of disc angular
position and auto
-
focusing function, digital image treatment (illumination corrections, background
correction, etc.), object detection within a image (segmentation) and WBC feature analysis and
classification.
The barcode on the pouch label prompts the instrument to conduct the appropriate test.
The instrument is delivered to the user pre
-
calibrated. If the instrument detects a malfunction, the
test will be interrupted with a display of the information code and the patient results will not be
reported. The user must refer to the spinit® User Manual to understand the cause of the infor-
mation code.
6
spinit® User Manual
|
spinit® system description
