Technology overview | The OraQuick HCV point‑of‑care test for rapid detection of hepatitis C virus antibodies | Advice

About the technology

CE marking

The CE mark for the OraQuick HCV rapid antibody test as a Class IIa medical device was last updated by OraSure Technologies in October 2013.

Description

The OraQuick HCV is a single‑use, point‑of‑care test for anti‑hepatitis C virus (HCV) antibodies. It provides a result in 20–40 minutes. The OraQuick HCV can use oral fluid, fingerstick whole blood, venepuncture whole blood, plasma or serum. HCV genotypes 1, 1a,1b, 1a/b, 2, 2a, 2a/c, 3, 3a, 3b, 3a/b, 4, 4a, 4c/d, 4h, 5a and 6a have all been tested by the manufacturer and are reactive to the OraQuick HCV.

Each test kit contains:

a pouch containing:
- the OraQuick HCV rapid antibody test plus absorbent packet
- an OraQuick HCV developer solution (0.75 ml phosphate buffered saline solution containing polymers and an antimicrobial agent)
reusable test stands
collection loops
package insert.

The manufacturer provides clear and comprehensive instructions for collecting samples of oral fluid, fingerstick whole blood, venepuncture whole blood, serum or plasma for testing using OraQuick. This includes advice for patients. All of the sample preparation processes use standard advice and equipment.

Tests results with the OraQuick HCV are ready in 20–40 minutes. If anti‑HCV antibodies are detected in the fluid sample, 2 red bands will be visible: 1 at the test line and the other at the control line. If the test sample is negative for anti‑HCV antibodies, a red band will be visible at the control line but not at the test line.

The OraQuick HCV test comes with quality control reagents that should be used when the manufacturer specifies:

when each new operator is using the kit
whenever a new test kit lot is opened
whenever a new shipment of kits is received
whenever the kit storage area falls outside of 2C‑30C (36F‑86F)
whenever the kit testing area falls outside of 15C‑37C (59F‑99F)
at periodic intervals dictated by the user facility.

Intended use

The OraQuick HCV is intended for use in people aged 11 years or older who show signs and symptoms that may be due to HCV infection, or who have risk factors for HCV infection.

Setting and intended user

The OraQuick HCV is used at the point of care by health care professionals such as doctors or nurses and, because no specialist equipment is needed, it can be used in any setting.

Current NHS options

Standard testing for anti‑HCV antibodies comprises either phlebotomy, in the case of dried‑blood spot testing, or a fingerstick blood sample. In both instances, the blood sample is sent to a laboratory where it is tested. Initially, blood is tested by enzyme immunoassay (EIA), also known as enzyme‑linked immunosorbent assay (ELISA). The blood sample is added to isolated antigens (in this case, HCV protein fragments) in a plate or well. Any anti‑HCV antibodies present in the blood sample bind their target antigen(s). A secondary, enzyme‑labelled antibody or antigen is then added, causing a change in colour that can be read visually or quantified by an automatic fluorescence reader.

Laboratory test results are available in about 1 week. A positive result for anti‑HCV antibodies shows that the person has been exposed to HCV. This does not mean that they have an active HCV infection, because anti‑HCV antibodies will remain in the blood even if the person's immune system has cleared a past infection.

Following a positive test result, either with standard laboratory EIA testing or with the OraQuick HCV, a second laboratory test is needed to test for the presence of HCV infection. This is a reverse transcriptase polymerase chain reaction (RT–PCR) test that detects HCV itself. A positive RT–PCR result indicates an active infection, and a negative result indicates that the patient has been infected in the past but has already cleared the virus.

NICE is aware of the following CE‑marked devices that appear to fulfil a similar function to OraQuick HCV:

Multiplo Rapid HBV/HIV/HCV Antibody Test (Medmira Laboratories): this point‑of‑care test can be used on fingerstick blood, serum, plasma and whole blood samples but not oral fluid samples.

Costs and use of the technology

The confirmed list price of the OraQuick HCV as of November 2014 is £12–15 (depending on volumes ordered).

The costs for conventional anti‑HCV antibody testing are given in table 1. These costs were taken from a health technology assessment (Castelnuovo et al. 2006), and where possible costs were updated using PSSRU 2013 (Curtis 2013).

Table 1 Costs of conventional anti‑HCV antibody testing

Item	Cost	Sources/notes
Cost of EIA test	£6.36	Example cost from Worcester Royal Hospital (provided by specialist commentator).
Cost of communicating results if EIA negative	£2.83	Assuming 1 letter to patient and 5 minutes of nurse time (nurse at GP practice, PSSRU 2013) to organise.
Cost of counselling, communicating results and offering referral if EIA positive	£40.83	One letter to patient (£2.83, as above), 1 GP visit to discuss results (10 minute consultation, at £3.80 per minute of patient contact, PSSRU 2013).
Cost of PCR	£113.00	£56.00 for PCR test, £57.00 for 1 specialist consultation (Castelnuovo et al. 2006).
Abbreviations: EIA, enzyme immunoassay; HCV, hepatitis C virus; PCR, polymerase chain reaction.

Likely place in therapy

The OraQuick HCV would be used in place of the existing EIA whole blood test in any setting where people at increased risk of HCV infection are offered testing. This could include primary care such as GP practices, sexual health clinics and mobile street clinics. By providing a rapid result, clinical staff may be able to offer further investigation and treatment before the person is lost to follow‑up.

Specialist commentator comments

One specialist commentator highlighted the test's high specificity, and said that this supported its use as a screening device. However, the commentator noted that the OraQuick HCV lacked sensitivity as a diagnostic test in some studies. Therefore, appropriate confirmatory testing would always be recommended for any patient testing positive using the OraQuick HCV.

One commentator noted that rapid testing, rather than standard laboratory testing of venous blood, could be useful in the event of an HCV outbreak. Another commentator said that the OraQuick HCV could be beneficial as a screening tool, particularly in populations that have infrequent or unreliable contact with the health care system. They also noted that the OraQuick HCV gave people a choice of fluid to be tested.

Two specialists recommended that before use, each OraQuick HCV test should be checked using the quality control reagents provided by the manufacturer. Another noted the importance of checking that the foil packaging is intact prior to testing, and that the test has not passed its expiry date.

One commentator stated that the reduced risk of needlestick injuries would also be a benefit for health care professionals administering the test.

One specialist commentator remarked that the OraQuick HCV does not test for hepatitis B. In some UK areas, a single dried blood spot is used to test for hepatitis B and C. Therefore, this may be missed when testing populations with high prevalence of hepatitis B such as people of Southeast Asian family origin.

Equality considerations

NICE is committed to promoting equality and eliminating unlawful discrimination. We aim to comply fully with all legal obligations to:

promote race and disability equality and equality of opportunity between men and women
eliminate unlawful discrimination on grounds of race, disability, age, sex, gender reassignment, pregnancy and maternity (including women post‑delivery), sexual orientation, and religion or belief, in the way we produce our guidance (these are protected characteristics under the Equality Act 2010).

The OraQuick HCV device could be used as part of the diagnosis of HCV in a number of high‑risk groups, many of which are protected by the Equality Act 2010. This includes older people, people of South Asian family origin, men who have sex with men, people who inject drugs and people with renal failure or haemophilia. Age, race, sexual orientation and chronic health conditions are protected characteristics under the Equality Act 2010.

Patient and carer perspective

The Hepatitis C Trust gave the following perspectives on the OraQuick HCV test.

In general the OraQuick HCV test was considered to be beneficial over standard testing as it the OraQuick HCV gives an immediate test result. However, this test has the disadvantage of detecting antibodies against HCV and therefore cannot confirm an active virus infection.

People taking the test have more control over the testing procedure, and can sample their own oral fluid, and this leads to less pain, anxiety and clean‑up than needlesticks for blood tests. People with compromised veins may experience pain and anxiety whilst the tester identifies a suitable vein to take a venous blood sample. Also people being tested have been fascinated with the simplicity of the test and pleased with the short time taken to give a test result. When people are given a positive OraQuick HCV test result this can provide them a strong motivation to undergo RT‑PCR testing to confirm active infection.

The people performing the OraQuick HCV test reflected that this test was a cleaner process as there was no blood waste or risk of blood spills. The people taking the test had no anxiety around the test and therefore had a greater trust and engagement with the tester. The testers found the test to be efficient, reliable and simple to read. They noted that the test is a similar technology to pregnancy tests and therefore the people being tested understood the test process, whereas blood tests needed expert interpretation to understand the results. As the samples were processed at the point of care, there was no need to range for storage or collection of samples and transporting these to the laboratory for testing. This reduced the complexity of the testing process. The HCV trust noted that as the OraQuick HCV test is very simple to use, the test can be performed by people who are not health care professionals.

A health worker who uses OraQuick HCV for testing people from the South Asian community gave their perspective. They noted that within the South Asian community the test had been well received. The test was suitable for Muslim people to use during Ramadan as no part of the test enters the body. Also as no blood is used this makes the test more acceptable at different venues such as Melas and Mosques. The health worker suggested that it would be very useful if the OraQuick HCV tested for Hepatitis B virus as well as HCV.