Terms and Conditions

Terms and Conditions of Service

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TERMS AND CONDITIONS OF SERVICE

1. DEFINITIONS

“Contract” means the contract between us and you for the provision of the national TB testing service, comprising these Conditions, the Service Description, the Request Form and, if applicable, a valid quotation or Service Agreement signed and accepted by You;

Request Form” means the form filled in by you to request the Service;

“Service” means the Oxford Diagnostic Laboratories TB testing service as described in the Service Description from time to time;

“Service Description” means the information detailing the Service and other related information;

“We” or “us” means Oxford Immunotec Limited (Registered Company no. 4516079);

“You” means the organisation identified on the Request Form to whom we will provide the Service.

2. APPLICATION OF CONDITIONS

2.1 The Contract will be the only term and conditions upon which we will supply the Service.  All other terms and conditions (including any contained on your purchase order) or representations are excluded, unless expressly agreed to in writing by one of our authorised representatives. For the avoidance of doubt, the Company’s sales representatives and Territory Managers are not authorised representatives.

2.2 The Contract constitutes the entire agreement between us.  We each acknowledge that we have not entered into the Contract on the basis of any warranty, representation, statement, agreement or undertaking except those expressly set out in the Contract.

3. DUTIES

We will provide the Service in accordance with the Service Description so long as you comply with the requirements set out in the Service Description.

4. NON-PERFORMANCE OF ASSAY

If we are unable or unwilling to perform the Service we will let you know (and the reason why) as soon as possible.

5. PAYMENT

5.1 Invoices must be settled in full by cash or in cleared funds to the bank account detailed on the invoice, within 30 days of invoice date.

5.2  All prices are quoted exclusive of VAT unless otherwise stated.

5.3  You will be invoiced at list price unless you enter a valid quote number on each test Request Form.

5.4 If you are late in settling our invoice, we reserve the right to claim interest under the Late Payment of Commercial Debts (Interest) Act 1998 at the rate of 8% above the Bank of England Base Rate.  We also reserve the right to add claimant claims compensation arising from late payment under section 5A of the Late Payment of Commercial Debts (Interest) Act 1998.

5.5 Despite the payment terms set out in the Service Description, we may require payment from you before we provide the Service and/or refuse to provide the Service if you owe us money.

5.6  You will have a credit limit of £2,500 unless otherwise agreed.

5.7  You will not be charged for indeterminate or non-reportable results.

6. QUALITY

Our provision of the Service is subject to the disclaimers set out in the Service Description.

7. LIMITATION OF LIABILITY

7.1 Nothing in these conditions will operate to exclude or limit our liability for death or personal injury arising out of our negligence or for our fraud in any way whatsoever.

7.2 Subject to condition 7.1, under no circumstance will we have any liability (whether in contract, tort (including negligence) or otherwise) under or in connection with the Contract for:

(a) indirect, special or consequential losses of any nature; (b) wasted or lost management time or time of other employees, loss of profits, contracts or business, loss of goodwill or loss of anticipated savings; or (c) any increased costs or expenses.

7.3 Subject to condition 7.1, our maximum total liability (whether in contract, tort (including negligence) or otherwise) under or in connection with the Service, will not exceed the total price of the Service.

7.4 The express terms of the Contract are in place of all warranties, conditions, terms, representations, undertakings and obligations implied by statute, common law, custom, trade usage, course of dealing or otherwise, all of which are excluded to the fullest extent permitted by law.

8. YOUR DUTY TO TAKE CARE

You shall indemnify us against any claim, proceedings, costs, loss, damage or liability as a result of any failure by you or any other person in control of assay results from the Service, to take such steps or ensure patient confidentiality or otherwise as a result of acts or omissions.

9. DELAY

We reserve the right to defer the date of delivery or cancel the Service or reduce the usage of the Service ordered by you (without liability to us) if we are prevented from or delayed in carrying on our business due to circumstances beyond our reasonable control.

10. GENERAL

10.1 You will comply with all relevant regulatory requirements in connection with the Service.

10.2 No person who is not a party to the Contract has any right to prevent the variation or cancellation of any provision of the Contract or its termination. No person who is not a party to the Contract may enforce any benefit conferred upon them by the Contract, unless the Contract expressly provides otherwise.

10.3 The Contract will be governed by English law and any dispute arising out of or in connection with the Contract must be dealt with in the English Courts.

10.4 It is your responsibility to retain the original results of the Service that are sent to you.

10.5 We may (but will not be obliged to) retain copies of results from the Service, and use such results for our own marketing or internal business purposes.

 

SERVICE DESCRIPTION

 

Oxford Diagnostic Laboratories (ODL®) offers a national TB testing service to laboratories and clinicians using the T-SPOT®.TB test.  Further information on the T-SPOT.TB test, including its limitations, is set out in our published documentation.

Specimen Acceptance Criteria

We require 6ml of blood collected in one standard heparin (green-topped) vacutainer tube. Pediatric samples require less blood (please call the laboratory to seek advice, as blood volumes depend on age). Samples must be accompanied with a completed ODL test Request Form and must reach ODL within 32 hours of venepuncture. Blood samples should be stored at 18-25°C; do not refrigerate samples. Please ensure that you include your Customer Account Number and Quote/Agreement Number on all test requests. Specimens must arrive by 2.00pm Monday to Saturday. ODL is closed on public holidays and over the Christmas and New Year period each year (please call us, or consult our website, to find out the exact dates for this year).

We place no restriction on the numbers of samples that can be sent at one time, however, if sending large numbers of samples we would appreciate advance notification to help us better plan our workflow. We endeavour to always provide results two working days after the sample is received by ODL.

What will Oxford Diagnostic Laboratories do?

1. We will carry out the Service, as described here and in the Terms and Conditions of Service, and following the instructions given on the test Request Form.

2. The service results will be sent by email (and fax if requested) to the requesting laboratory within 2 working days of receipt of sample.

3. The invoice for the Service will be sent by post within 3 further working days, unless otherwise agreed.

4. ODL will be responsible for disposal of any samples provided.

Results Interpretation and Quality Control

A typical result would be expected to have few or no spots in the Nil Control and ≥20 spots in the Positive Control. Each spot represents the footprint of an individual cytokine-secreting T cell, and evaluating the number of spots obtained provides a measurement of the abundance of M. tuberculosis complex sensitive effector T cells in the peripheral blood.

A Nil Control spot count in excess of 10 spots should be considered as ‘Indeterminate’. Refer to the T-SPOT.TB Technical Handbook for possible causes (download from www.oxfordimmunotec.com). If this occurs, another sample should be collected from the individual and sent to ODL for testing.

Typically, the cell functionality Positive Control spot count should be ≥ 20 or show saturation (where spots are too numerous to count).  A small proportion of patients may have T cells which show only a limited response to PHA.   Where the Positive Control spot count is < 20 spots, it should be considered as ‘Indeterminate’, unless either Panel A or Panel B is ‘Positive’ as described below, in which case the result is valid.

The T-SPOT.TB test results are interpreted by subtracting the spot count in the Nil Control well from the spot count in each of the Panel wells, according to the following algorithm:

  • The test result is ‘Positive’ if (Panel A minus Nil Control) and / or (Panel B minus Nil Control) ≥ 6 spots.
  • The test result is ‘Negative’ if both (Panel A minus Nil Control) and (Panel B minus Nil Control) ≤ 5 spots. This includes values less than zero.

Due to potential biological and systematic variations, where the higher of (Panel A minus Nil Control) and (Panel B minus Nil Control) is 5, 6 or 7 spots, the result may be considered as Borderline (equivocal). Borderline (equivocal) results, although valid, are less reliable than results where the spot count is further from the cut-off. Retesting of the patient, using a new sample, is therefore recommended.

A ‘Positive’ result indicates that Tuberculosis infection is likely.

A ‘Negative’ result indicates that Tuberculosis infection is unlikely.

The results should be used and interpreted only in the context of the overall clinical picture.  A negative test result does not exclude the possibility of exposure to or infection with M. tuberculosis.

This assay is performed under license from the Public Health Research Institute.

T-SPOT, ODL and the Oxford Diagnostic Laboratories logo are trademarks of Oxford Immunotec Ltd

© 2011 Oxford Immunotec

Form 10-007.06 V3