NATA have finally released information regarding Saliva Drug Testing device standards under AS/NZS4760-2006.
We have known for a substantial amount of time that NATA had withdrawn the accreditation for onsite Oral Fluid/Saliva drug testing devices, because we were attempting to get our devices Certified for AS4760 compliance.
They have just made an official announcement to that effect:
Having conducted several assessments, it has become apparent that there are a number of significant issues with Section 3 of AS 4760:2006 which remain unable to be resolved. This is despite NATA seeking independent feedback to clarify these issues from key professional bodies including the Royal College of Pathologists of Australasia (RCPA), the Australasian Association of Clinical Biochemists (AACB) and from our counterpart organisation in New Zealand, International Accreditation New Zealand (IANZ).
Accordingly, NATA has not granted accreditation to any facility for AS 4760, Section 3 and a decision has now been made to withdraw the provision of accreditation for this testing. A communication to this effect was sent to NATA‟s stakeholders in July 2013.
Until further notice NATA will no longer accept applications for accreditation in this area and any current applications will no longer be progressed.
The issues identified in relation to this testing include the following. There are no prescribed cut-off concentrations for screening devices or set quality control limits as there are for urine screening devices as detailed in Appendix A of AS/NZS 4308:2008.
The target concentrations for screening devices in Table 3.1 are described as “nominated” in Section 1.5. This section also states that “there is yet to be an accepted cut-off concentration” and that “concentrations higher than the initial testing target concentrations may sometimes be used if sensitivity is the limiting factor but this reduces the ability to detect drug use”.
Accordingly, a facility may nominate its own targets (but not lower than those in Table 5.1 used for confirmatory testing). Where the nominated targets are set higher than those in Table 3.1 by the facility due to the insensitivity of a screening device, false negative results may result, despite compliance with the Standard. This would be a key concern for both drug screening programs and the public.
The ability to test for drugs with known instability in saliva post collection, especially tetrahydrocannabinol (THC), is compounded by the allowance of “nominated” targets. The allowance of nominated screening concentrations at levels at or above the confirmatory concentrations may impact on the ability of confirmatory testing to reproduce a non-negative screening result due to loss of drug during transport and handling.
There are no acceptance criteria for what constitutes acceptable verification of screening devices as there are for urine screening devices as detailed published in Appendix B of AS/NZS 4308:2008.
The Standard requires quality control (QC) to be run. However, it is noted that the negative QC is defined as a drug free specimen. Such a specimen does not test the sensitivity of a device to identify donor samples which contain drugs at a concentration below the nominated target cut-offs. This is inconsistent with Appendix A of AS/NZS 4308:2008 which requires the below cut-off QC to be at a concentration between 25% and 50% below the cut-off concentration.
The positive control is at or within 50% above the nominated concentrations. This is also inconsistent with AS/NZS 4308:2008 which requires the positive control to be between 25% and 50% above the cut-off concentrations (in Table 1).
Essentially it is clear that Saliva/Oral Fluid Workplace Drug Testing is still good practice, however care should be taken to ensure the devices used indeed do what they say they do, I.E. if the device manufacturer says the cutoff is 50ng/ml there should be QC analysis available to say that is what it actually does within the +50% tolerance.
It is then up to the Workplace to establish this as their target cut off for tests.
If you require further information, please don't hesitate to contact us at MediNat Australia email: info@medinat.com.au
We have known for a substantial amount of time that NATA had withdrawn the accreditation for onsite Oral Fluid/Saliva drug testing devices, because we were attempting to get our devices Certified for AS4760 compliance.
They have just made an official announcement to that effect:
Having conducted several assessments, it has become apparent that there are a number of significant issues with Section 3 of AS 4760:2006 which remain unable to be resolved. This is despite NATA seeking independent feedback to clarify these issues from key professional bodies including the Royal College of Pathologists of Australasia (RCPA), the Australasian Association of Clinical Biochemists (AACB) and from our counterpart organisation in New Zealand, International Accreditation New Zealand (IANZ).
Accordingly, NATA has not granted accreditation to any facility for AS 4760, Section 3 and a decision has now been made to withdraw the provision of accreditation for this testing. A communication to this effect was sent to NATA‟s stakeholders in July 2013.
Until further notice NATA will no longer accept applications for accreditation in this area and any current applications will no longer be progressed.
The issues identified in relation to this testing include the following. There are no prescribed cut-off concentrations for screening devices or set quality control limits as there are for urine screening devices as detailed in Appendix A of AS/NZS 4308:2008.
The target concentrations for screening devices in Table 3.1 are described as “nominated” in Section 1.5. This section also states that “there is yet to be an accepted cut-off concentration” and that “concentrations higher than the initial testing target concentrations may sometimes be used if sensitivity is the limiting factor but this reduces the ability to detect drug use”.
Accordingly, a facility may nominate its own targets (but not lower than those in Table 5.1 used for confirmatory testing). Where the nominated targets are set higher than those in Table 3.1 by the facility due to the insensitivity of a screening device, false negative results may result, despite compliance with the Standard. This would be a key concern for both drug screening programs and the public.
The ability to test for drugs with known instability in saliva post collection, especially tetrahydrocannabinol (THC), is compounded by the allowance of “nominated” targets. The allowance of nominated screening concentrations at levels at or above the confirmatory concentrations may impact on the ability of confirmatory testing to reproduce a non-negative screening result due to loss of drug during transport and handling.
There are no acceptance criteria for what constitutes acceptable verification of screening devices as there are for urine screening devices as detailed published in Appendix B of AS/NZS 4308:2008.
The Standard requires quality control (QC) to be run. However, it is noted that the negative QC is defined as a drug free specimen. Such a specimen does not test the sensitivity of a device to identify donor samples which contain drugs at a concentration below the nominated target cut-offs. This is inconsistent with Appendix A of AS/NZS 4308:2008 which requires the below cut-off QC to be at a concentration between 25% and 50% below the cut-off concentration.
The positive control is at or within 50% above the nominated concentrations. This is also inconsistent with AS/NZS 4308:2008 which requires the positive control to be between 25% and 50% above the cut-off concentrations (in Table 1).
Essentially it is clear that Saliva/Oral Fluid Workplace Drug Testing is still good practice, however care should be taken to ensure the devices used indeed do what they say they do, I.E. if the device manufacturer says the cutoff is 50ng/ml there should be QC analysis available to say that is what it actually does within the +50% tolerance.
It is then up to the Workplace to establish this as their target cut off for tests.
If you require further information, please don't hesitate to contact us at MediNat Australia email: info@medinat.com.au
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