INSTi 2in1 - HIV and syphilis test
INSTi 2in1 - HIV and syphilis test
INSTi 2in1 - HIV and syphilis test

INSTi 2in1 - HIV and syphilis test

CZK 649.00
CZK 579.46 excl. VAT i
The applicable VAT rate is 12% – Czech Republic.

The INSTI Multiplex test can detect both HIV and syphilis in 60 seconds in a single test.  A very effective tool to identify people in need of treatment for HIV and/or syphilis to prevent mother-to-child transmission. For professional use.

Reference
INSTI MULTIPLEX
Delivery date on request
INSTI Multiplex HIV-1/2 Syphilis Ab – professional HIV and syphilis test
When the test is useful
The increasing incidence of HIV and syphilis represents an important public health concern. The INSTI Multiplex HIV-1/2 Syphilis Ab Test enables professional screening of antibodies to HIV-1, HIV-2 and Treponema pallidum simultaneously on one device.
Testing is performed using fingerstick blood or EDTA whole blood, serum or EDTA plasma. A valid result is usually readable within 1 minute, making the test suitable for point-of-care use in healthcare settings.
The test is intended for professional use by healthcare personnel. It is not approved for home self-testing.
The test is suitable for medical facilities, clinical laboratories, emergency care and physicians’ offices where a rapid professional screening result from blood is required.
When the test makes sense
  • When rapid professional screening for HIV and syphilis at the same time is needed.
  • In point-of-care settings where a result is required within minutes.
  • For testing fingerstick blood as well as EDTA whole blood, serum or plasma.
  • As a preliminary screening tool before confirmatory laboratory testing.
Main benefits
  • Simultaneous detection of antibodies to HIV-1, HIV-2 and syphilis in one test.
  • Rapid flow-through principle with valid results usually within 1 minute.
  • Detection of both IgG and IgM antibodies.
  • Simple procedure without complex sample preparation.
  • Integrated control dot confirms correct test performance.
Easy to use
  • The test uses flow-through membrane technology with visual readout.
  • The kit includes the test device and support materials for fingerstick sampling.
  • The sample is added to the diluent and then applied step by step to the device.
  • The result must be read immediately after completion, no later than 5 minutes after adding the third solution.
Warning: Any reactive or indeterminate result is preliminary and must be confirmed by laboratory testing.
Kit contents
The test kit contains everything needed to perform 1 test:
  • 1 INSTI Multiplex test device,
  • 1 vial of Sample Diluent (Solution 1),
  • 1 vial of Colour Developer (Solution 2),
  • 1 vial of Clarifying Solution (Solution 3),
  • 1 single-use alcohol swab,
  • 1 single-use lancet,
  • 1 single-use 50 μl pipette,
  • instructions for use.
Clinical performance
According to the official instructions for use, the HIV component of the test achieved relative sensitivity of 100.0% (517/517) and relative specificity of 99.5% (1375/1382) for fingerstick blood. For syphilis, the manufacturer reports positive percent agreement of 96.9% (62/64) and negative percent agreement of 100% (105/105) versus the TP-PA reference method for EDTA whole blood.
Parameter Value
Measured parameter Antibodies to HIV-1, HIV-2 and Treponema pallidum
Sensitivity HIV-1/2 relative sensitivity 100.0%; syphilis positive percent agreement 96.9%
Specificity HIV-1/2 relative specificity 99.5%; syphilis negative percent agreement 100%
Read time Valid result usually within 1 minute; do not interpret more than 5 minutes after adding Clarifying Solution
Storage
  • Store the kit at 15 to 30 °C.
  • All components are intended for single use only.
  • EDTA whole-blood specimens should be tested within 48 hours and must not be heated or frozen.
  • Serum or EDTA plasma may be stored at 2 to 8 °C for up to 5 days; frozen at ≤ -20 °C for 3 months or at ≤ -70 °C for 1 year.
Additional information
The product manufacturer is the Canadian company bioLytical Laboratories, Inc.
A positive syphilis result does not necessarily indicate active infection because antibodies to T. pallidum may remain detectable even after treatment.
Patients in the early primary stage of syphilis may test negative because the assay has lower affinity for IgM than for IgG.
Technical parameters
Test type Professional rapid flow-through in vitro immunoassay
Measured parameter Antibodies to HIV-1, HIV-2 and syphilis
Specimen Fingerstick blood, EDTA whole blood, serum, EDTA plasma
Result Usually within 1 minute
Tests per pack 1
Kit contents Test device, Sample Diluent, Colour Developer, Clarifying Solution, alcohol swab, lancet, 50 μl pipette, instructions
Storage 15 to 30 °C
Intended use Professional use, not approved for home self-testing
Manufacturer bioLytical Laboratories, Inc., Canada

INSTi_HIV+Syfils_navod

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Expiration date:
2027-03

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