An Example of How Rural Clinical Laboratories Can Introduce HIV Testing Cost Effectively

Abstract

Aspirus Keweenaw Hospital is a rural critical care facility. The laboratory and emergency department were interested in implementing rapid HIV testing in-house, as there is an average of 8 to 12 health care provider needlesticks annually. A rapid HIV test offers a quick result to rule out HIV transmission to health care providers and can expedite appropriate treatment when warranted.

Rapid HIV testing, management, Human Immunodeficiency Virus, needlestick

Small rural hospitals are often dependent upon reference laboratories for both routine and urgent results. With the recent availability of waived rapid HIV testing, Aspirus Keweenaw Hospital (Laurium, MI) evaluated bringing this test in-house. Aspirus Keweenaw was sending all urgent HIV testing to Marquette General Hospital, Marquette, MI. These urgent results are almost exclusively for testing a source patient after a health care provider (HCP) was exposed to blood. A HCP exposure includes percutaneous injury, mucus membrane contact, or contact to skin with a large quantity of source patient fluid. Implementing an in-house rapid HIV test allows physicians to correctly treat blood-exposed HCPs by not placing them on postexposure prophylaxis (PEP) for treatment of HIV. This rapid test saves the hospital and HCP financially and reduces the risk to the HCPs of toxic PEP.

Aspirus Keweenaw is a critical care facility with a maximum patient load of 24 beds. With an annual average of 8 to 12 HCP needlesticks, a potential need for a rapid, in-house HIV test was recognized.

Demand for a New Test

Emergency department physicians requested the rapid HIV test because they needed a fast, accurate result when HCP needlesticks occurred. When a HCP needlestick occurs, an HIV baseline test result for both the HCP and patient to whom the HCP was exposed is established. This result helps the physician decide if it is necessary to start PEP. Secondly, this rapid test can be used for late-term pregnant women with unknown HIV status in order to provide appropriate therapy to protect the baby.

At the time this study was initiated, the hospital waited on average 2 days for an HIV result on a sample sent to Marquette General Hospital. The cost of each test was $31.40. The rapid test would dramatically decrease turnaround time (TAT) by providing a result approximately 15 minutes after the blood was received in the laboratory, requiring minimal time from a technologist, and providing emotional relief by giving involved HCPs a quick result.

Since this rapid test is a single-use cassette, no costly instruments are required to run the test. This benefits Aspirus Keweenaw because the alternative screen for HIV is done on an enzyme immunoassay (EIA) instrument. This instrument is quite costly and requires more space than Aspirus Keweenaw has available. The rapid HIV kit (Clearview by Inverness) with 20 tests ($14.50 per test) costs $290, with multi-use controls costing $34.45.¹

In 2001, a study compared the cost-effectiveness of rapid HIV testing to EIA testing. This study was conducted during a period of 13 months on 17 HCP exposures (Table 1).² It indicated the cost of rapid HIV testing is dramatically lower than EIA testing ($465.80 vs. $5,965.81, respectively).² For larger hospital laboratories with a higher volume of HIV testing, EIA testing in the long run would be cost-effective because the cost per test is less than the rapid test, and the initial cost of the instrument would be returned over time. However, in a small rural hospital, the rapid HIV assay is the most cost-effective way to achieve a fast and accurate result.

Diagnosis and Treatment

The prevalence of HIV in selected Michigan counties is presented in Table 2. The Western Upper Peninsula (U.P.) has a population of 69,985, of which 15 individuals are known to have HIV. The prevalence of HIV in the Western U.P. is 0.0214%.³ Using the Clearview Rapid HIV test sensitivity (99.7%) and specificity (99.9%), this test in the Western U.P. will have a positive predictive value (PPV) of 17.60% and a negative predictive value (NPV) of 99.99%. These results show a positive result is more likely to be a false positive than a true positive due to the low prevalence of HIV in the testing population. These characteristics make this assay an excellent screening test to rule out HIV transmission in low prevalence settings.

Products Available

After examining the demand and background information on HIV, a research team, including the laboratory director and an analytical expert/graduate student, explored EIA and rapid testing. Due to the cost, small laboratory size, and low test volume (8 to 12 tests annually) at Aspirus Keweenaw, it was decided that EIA instrumentation would not be appropriate. Two testing systems available that detect both HIV-1 and HIV-2 are the Clearview Rapid HIV-1/2 STAT-PAK and the OraQuick ADVANCE Rapid HIV-1/2 Antibody Test. For example, in Table 3, the Clearview rapid HIV test is CLIA waived when using whole blood, consists of 2 steps (15 min), is reliable (99.7% sensitive and 99.9% specific), requires a small sample size (5 μl), and has a shelf life of 2 years for controls and test cassettes.¹ The other close competitor, the OraQuick rapid HIV test, is CLIA waived when using whole blood, can be read in 20 min and is reliable (99.6% sensitive and 100% specific).⁴

Table 1

EIA and Rapid HIV Test Cost Comparison²

Cost	Rapid Testing	EIA Testing
Cost to laboratory	$465.80	$212.16
Cost of medication	—	$2,353.65
Cost of time lost from work	—	$3,400.00
Total cost	$465.80	$5,965.81

Table 2

HIV Prevalence and Predictive Value Using Clearview Rapid HIV 1/2 STAT-PAK in Selected Michigan Counties/Areas³

Location	Prevalence (%)
Western U.P.	.0214
Grand Traverse	.0553
Huron	.0088
Kent	.1176
Detroit	.6016
Western U.P.
Population	69,985
Patients with HIV	15
True positive tests	14.955
False negative tests	.045
True negative tests	69,900
False positive tests	70
Positive predictability	17.60%
Negative predictability	99.99%
Efficiency	99.89%

Table 3

OraQuick and Clearview Rapid HIV Comparison Charts^1,4

	FDA Approval	Specimen Type	CLIA Specification	Sensitivity	Specificity
OraQuick ADVANCE rapid HIV-1/2 antibody test	November 2002	Oral Fluid	Waived	99.3%	99.8%
		Whole Blood	Waived	99.6%	100%
		Plasma	Moderate Complexity	99.6%	99.9%
Clearview rapid HIV-1/2 STAT-PAK	May 2006	Whole Blood	Waived	99.7%	99.9%
		Serum & Plasma	Moderate Complexity	99.7%	99.9%

	Storage Temperature	Operating Temperature	Shelf-Life of Test	Shelf-Life of Controls	Time Required to Run Test	Window for Reading Result
OraQuick ADVANCE rapid HIV-1/2 antibody test	2–27°C (tests)	15–37°C	8 months	12 months	<5 minutes and 20 min wait time	20–40 minutes
	2–8°C (controls)			8 weeks after opening
Clearview rapid HIV-1/2 STAT-PAK	8–30°C (tests)	18–30°C	24 months	24 months	<5 minutes and 15 min wait time	15–20 minutes
	2–8°C (controls)

	Price Per Test (2007)	Price Per Test (2008)	External Controls	Number of Tests per Kit	Manufacturer
OraQuick ADVANCE rapid HIV-1/2 antibody test	$17.50	$13.56	Sold Separately ($97.00)	25	Abbott Diagnostics
Clearview rapid HIV-1/2 STAT-PAK	$25.00	$14.50	Sold Separately ($34.45)	20	Inverness Medical Professional Diagnostics

A study of the OraQuick rapid HIV test was conducted in November 2007. It involved 12 health departments and showed that all reported false-positive results came from the OraQuick rapid HIV test.⁵ The OraQuick test cassettes have a shelf-life of 8 months, and the controls, once open, are valid for 8 weeks.⁴ The cost associated with these 2 products is $13.56 per test for OraQuick and $14.50 per test for Clearview, while controls are $97.00 for OraQuick and $34.45 for Clearview.^1,4

The rapid test implemented at Aspirus Keweenaw will be used in urgent (STAT) situations only, so whole blood (no centrifuging required) will be used to improve TAT. Since this test will use whole blood, it will fall under the CLIA waived category. CLIA waived rapid HIV testing has no federal requirements for personnel, proficiency testing, or quality assessment. A certificate of waiver from CLIA must be obtained by the testing facility, and manufacturer’s instructions must be followed. A moderately complex rapid HIV test must be registered with CLIA and follow CLIA standards in quality assessment, personnel, proficiency testing, and inspections.⁶ This is of importance because by using a waived test, less constraints are in place for the personnel performing the test, quality control, degree of proficiency testing, and scrutiny of inspection by accrediting agency.

Interaction with Vendors

With the research concluded, Inverness and Abbott became more involved with the implementation process. A contact list was obtained from each vendor so a representative from the laboratory could visit other facilities using the rapid HIV test systems. After observing the practice of rapid HIV testing in a few area hospitals, there were no particular issues of concern and the reliability of the vendors (Abbott and Inverness) appeared to be satisfactory. One area hospital uses OraQuick ADVANCE Rapid HIV-1/2 for employee exposures and pregnancies and they reported that rapid testing was less work than the process to send out the test. There were few positive test results, including survey samples (with a performance of 100%) and 1 known HIV patient, so no patient specimens had been sent out for confirmatory testing. Sample test kits from Inverness and Abbott were brought in and tested in Aspirus Keweenaw with known positive and negative controls. Both testing systems correlated 100% with their expected results, but Clearview’s procedure was easier to use with fewer manual steps.

Vendor Decision

In Table 4 Aspirus Keweenaw calculated the costs of obtaining rapid HIV testing. The Clearview rapid test costs $14.50 per patient, while reimbursement for this test is $18.57. The cost for sending out an HIV test is $58.45, while reimbursement is $27.05. In 1 occurrence of a HCP needlestick, if both the source patient and HCP test are negative, the laboratory will save $8.14 with no PEP required. If the source patient is positive and the HCP is negative, the laboratory will lose $23.26 due to sending out the source patient for confirmatory Western Blot analysis. However, if rapid HIV testing is not used at all (its current state), the hospital will lose $62.80 by sending out samples to a reference laboratory. From a cost analysis standpoint, it was determined that rapid HIV testing would be cost effective for the laboratory by yielding a profit when both tests are negative. A decrease in loss would occur if the source patient tests positive.

Table 4

Cost Analysis for HCPs at Aspirus Keweenaw Using Clearview Rapid HIV Testing^1,4

	Cost of Rapid Test to Hospital	Reimbursement of Rapid Test	Cost of Therapy if Rapid Test is Positive	EIA/Western Blot Send-Out Cost to Hospital	Reimbursement of EIA/Western Blot	Total Cost to Patient	Total Cost/Revenue to Hospital
Situation 1
Rapid result negative on source patient	$14.50	$18.57	0	0	0	$18.57	+$4.07
Rapid result negative on HCP	$14.50	$18.57	0	0	0	$18.57	+$4.07
Situation 2
Rapid result positive on source patient	$14.50	$18.57	—	$58.45	$27.05	$45.62	−$27.33
Rapid result negative on HCP	$14.50	$18.57	$22.64–$77.20*	—	—	$18.57 for rapid test	+$4.07
						$22.64–$77.20* for therapy
Situation 3 (no rapid HIV test)
Source patient and HCP	—	—	—	$116.90	$54.10	$27.05 per person + HCP therapy	−$62.80

*

Range is dependent on if the result is returned in 1 or 2 days, risk, and the type of treatment.

Based on this comparison of the ease of use and cost, the Clearview assay was chosen by the laboratory director. Clearview’s easier procedure, rapid result, 2-year shelf-life of both controls and test cassettes, and lower cost for controls made this assay the preferred product. Thus the laboratory director recommended the addition of Clearview to the laboratory testing menu. This decision was approved by hospital administration.

Test Implementation

The testing of HIV via a rapid method has specific requirements. The FDA has specific sales restrictions stating that the laboratory must be CLIA certified; has a quality assessment program; provides training to personnel; provides manufacturer’s subject information to test subjects; and does not use the test to screen blood/tissue donors. CLIA’s requirements for rapid HIV testing include having a CLIA certificate, following manufacturer’s instructions, and allowing inspection by Centers for Medicare and Medicaid Services (CMS).⁷ There are also Occupational Safety and Health Agency (OSHA) regulations that must be followed including, but not limited to, having an exposure control plan, providing personal protective equipment, providing post-exposure evaluation/follow up to employees, providing training for occupational exposures, and disposing of biohazard waste correctly.⁶ Specific regulations that vary by state could also apply. Aspirus Keweenaw is accredited by the Commission on Office Laboratory Accreditation (COLA), which has the same requirements as CLIA for rapid HIV testing.

Physicians should also have a referral system in place for additional services (eg, mental health, substance abuse treatment, etc.), and the patient must be provided with the manufacturer’s handout stating how to interpret results from a rapid HIV test. Since this waived test will be conducted within the laboratory, the emergency department will be given manufacturer’s handouts to be distributed to HCPs when a needlestick occurs.

Documentation

Creation and maintenance of documentation not only follows good laboratory practices, but it is also required by accrediting agencies for all testing, including waived testing. With this waived rapid HIV test, as with other forms of testing, the laboratory should always keep a current copy of the product insert for reference. The laboratory must follow the storage requirements for the test kits and never mix components of different kits. The results of each test must be recorded along with the results of the external and internal controls. The laboratory must keep up with all maintenance as described by the manufacturer. Additionally, test storage, test system operations, and reporting of results must be consistent with the manufacturer’s instructions. A laboratory’s policies and procedures should include confidentiality of results (regardless of the result), informed consent, counseling, confirmatory testing, and reporting of results.

A professional trained on the Clearview Rapid HIV test was in charge of creating and editing documentation for this test. For this Clearview Rapid HIV test, the technical procedure was adopted and edited from the Inverness Web site, while the following documents were adopted and edited from the Michigan Department of Community Health Web site: initial training form, 6-month training form, yearly training form, QA manual, temperature log, client log, inventory sheet, external QC log, discrepant results form, corrective action form, organizational structure form, personnel form, staff questionnaire, flow diagram of testing, and comparison study sheet.^1,8 Documentation does not conclude here; it encompasses training and competency of laboratory personnel as well.

Personnel Training and Competency

Maintaining competency in a test is not only good laboratory practice, but it is also required by multiple regulatory agencies. In Aspirus Keweenaw’s case, only a select few employees from each shift will be trained to keep training costs down due to the low-testing volume. Employees at Aspirus Keweenaw will be trained initially, and competency will be evaluated after 6 months, 1 year, and then annually.

Proficiency Testing

Proficiency testing will be offered through Aspirus Keweenaw’s current proficiency program, the Wisconsin State Laboratory of Hygiene (WSLH), which is accepted by CAP, COLA, CMS, and The Joint Commission for proficiency testing. This program offers a yearly proficiency test ($168) including 3 1 mL samples twice annually. The testing volume required for Clearview is 5 μL. The WSLH also offers a Veri-Samp program ($100) for anti-HIV testing that can be used for employee competency and test validation.⁹

Conclusion

Maintaining viability is essential for rural hospitals. Decisions must be made to select which tests are to be done in-house and which tests should be sent to reference laboratories. By taking a stepwise approach to new test implementation, a clinical laboratory was able to make an informed decision on the right HIV test to bring in-house.