3.152.XXX.YY.ZZZ

Organization name

OPERON, S.A.

SRN

ES-MF-000004790

Manufacturer status

Active

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• CW265

  The denaturation solution contains < 2% NaOH

Primary placement in Spain; available across 9 countries total.

Trade name

not provided

UDI-DI code

D-84295773152WPFZ

Basic UDI-DI

B-84295773152WPFZ

Reference / catalog number

3.152.XXX.YY.ZZZ

Issuing entity

EUDAMED

Risk category

IVDD — Annex II List B

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The CeliacStrip test is a test designed to aid in the diagnosis of celiac disease by detecting the main HLA haplotypes associated with this condition. The test detects the presence or absence of the alleles that encode for HLA-DQ2 and HLA-DQ8: HLA-DQ2.5, HLA-DQ8, HLA-DQ2.2 and HLA-DQ7.5, making it possible to estimate the risk of having coeliac disease based on the detected combination of alleles. In addition to HLA-DQA1 and HLA-DQB1 alleles, the test can also detect DRB1* alleles (DR3, DR4, DR7, DR11 and DR12). These alleles are used to increase the resolution and specificity of the genotyping and enable genotype definition in the event of more complex haplotypes. This test is simply a tool to help medical professionals diagnose the indicated disease. In the case of coeliac disease, it is important to note that HLA typing has a high negative predictive value (almost 100 %), but its positive predictive value is low. Therefore, it should not be used as the only way of diagnosing coeliac disease, given that approximately 35-40 % of the general population has heterodimers DQ2.5 and DQ8, but only around 1 % have coeliac disease. Other parameters, such as any apparent symptoms, results from other analytical tests, and the patient’s medical history should be considered when concluding a diagnosis. The test is performed using DNA samples. This DNA can be extracted from blood (with EDTA or citrate) or salive. The test is qualitative and its execution is not fully automated, although parts of the process can be automated: 1. Hybridization/developing process: Automatic thermoshakers can be used (see point “Required equipment for kit development”. 2. Results interpretation: The results can be interpreted using a scanner (see point “Optional equipment for the interpretation of the strips”). This test is exclusively for in vitro diagnostic use. It is a professional use product. It is not a self-testing product. It is not a near-patient testing product.

Additional information URL

https://www.operondx.com/

Clinical sizes

No clinical sizes registered for this device.

• W0106010401HLA-TYPING

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