ABBOTT PRISM® HTLV-I/HTLV-II - ILEX Medical Systems

© 1995, 2005 Abbott / Printed in Germany / ABBOTT PRISM HTLV-I/HTLV-II 

October 2005 

ABBOTT 

Diagnostics Division 

Store at 2-8°C 

1 

E 

ABBOTT PRISM ® HTLV-I/HTLV-II 

6A53-48 

B6A530 

56-4240/R13 

ABBOTT PRISM ® HTLV-I/HTLV-II 

Human T-Lymphotropic Virus 

Types I and II Antigen (Inactivated) 

NOTE: This package insert must be read carefully prior to product use. Package insert instructions 

must be carefully followed. Reliability of assay results cannot be guaranteed if there are any deviations 

from the instructions in this package insert. 

NOTE: If you receive reagents, calibrators, controls or bulk solutions that are in a condition contrary to 

the package insert or label recommendation, or that are damaged, contact your local customer service 

organization. 

For use with software version 2.1 or higher 

0088 

List Number 

Key to symbols used 

For In Vitro Diagnostic Use Expiration Date 

Store at 15-30°C 

CAUTION: Handle human 

sourced materials as potentially 

infectious. Consult instructions for 

use. 

Consult instructions for use 

Legal 

Manufacturer 

Note Changes Highlighted 

Lot Number 

Master Lot 

Sample Cups 

Calibrators 

Pipette Tips 

Line Cleaner 

Assay Kit Card 

Reaction Trays 

Reagent 

Components 

Run Control 

Adapters 

See REAGENTS section for a full explanation of symbols used in reagent component naming.

U. S. Patent No. 4, 380, 580, licensed under patent rights of Bayer Corp. Tarrytown, 

New York, USA, relates to this product. 

NAME AND INTENDED USE 

The ABBOTT PRISM ® HTLV-I/HTLV-II assay is an in vitro chemiluminescent 

immunoassay (ChLIA) for the qualitative detection of antibodies to human 

T-lymphotropic virus type I and/or human T-lymphotropic virus type II (anti-HTLV-I/ 

HTLV-II) in human serum or plasma. The ABBOTT PRISM HTLV-I/HTLV-II ChLIA 

is intended as a screen for donated blood to prevent transmission of HTLV-I and 

HTLV-II to recipients of blood and blood components and as an aid in the diagnosis 

of HTLV-I and HTLV-II infections. 

SUMMARY AND EXPLANATION OF THE TEST 

HTLV-I, a human Type-C retrovirus, 1,2 has been etiologically associated with 

neoplastic conditions and a variety of demyelinating neurologic disorders including: 

adult T-cell leukemia (ATL), 3 tropical spastic paraparesis (TSP) 4,5 and/or HTLV-I 

associated myelopathy (HAM) 6 and more recently HTLV-I associated polymyositis, 

arthritis and infective dermatitis. 7-9 Antibodies to HTLV-I are found with high 

frequency in persons afflicted with these disorders. However, it is well established 

in studies from viral endemic areas that HTLV-I antibody negative ATL and TSP/HAM 

are seen. 10-12 

HTLV-I infection is endemic in the Caribbean, 11 south-eastern Japan, 12 in some 

areas of Africa, 13 Central and South America, 14 and recently described in 

Melanesia 15,16 and central and northern Australia. 17,18 In the United States, HTLV-I 

has been identified in ATL patients, intravenous drug users and in healthy 

individuals. 19-23 Transmission of HTLV-I (and HTLV-II) infection to transfusion 

recipients of infected cellular blood products is well documented. 24-29 Transmission 

also occurs via breast milk, 30 sexual contact, 31,32 and sharing of contaminated 

needles and syringes by intravenous drug users. 20,23,33 

HTLV-I causes ATL in only 2 to 4% of infected individuals and typically only after 

long latency periods. 34,35 The ATL syndrome appears to result from exposure early 

in life as occurs during maternal transmission via breast milk. 30 Approximately 20 

to 25% of children exposed to HTLV-I through breast feeding develop antibodies to 

HTLV-I. 30,36-38 Perinatal transmission of HTLV-I occurs in approximately 5% of nonbreast 

fed children born to infected mothers. 37,38 Following transfusion of cellular 

blood components in HTLV-I endemic areas, 44 to 63% of recipients 

seroconvert; 25,39 however, lower seroconversion rates (approximately 20%) have 

been reported in recipients of contaminated blood in the U.S. 27,28 Infection with 

HTLV-I during adult life results in TSP/HAM-like illness, and not in ATL. 9 The lifetime 

risk for TSP/HAM for those who live in an endemic area is estimated at less than 

1%. 34,35 The presence of HTLV-I antibodies in an asymptomatic person indicates 

that the individual may be infected with the virus and should not donate blood, 38,40,41 

but does not mean the individual has ATL or TSP/HAM or will develop ATL or 

TSP/HAM. 34,38,41 Consultation with appropriate medical personnel is recommended 

for discussion of additional concerns related to viral infection and its transmission. 

HTLV-II was first isolated from a patient having T-lymphocytic-hairy cell 

leukemia. 42,43 Association of HTLV-II with leukemia pathogenesis is not well 

established; however, some cases of neurologic diseases resembling TSP/HAM 

have been recently reported to be due to HTLV-II. 44-47 Epidemiologic data suggest 

that HTLV-II is a new-world virus common among Amerindians in North, Central 

and South America. 14 

Transmission of HTLV-II, like HTLV-I, occurs via transfusion of cellular blood 

components, between needle-sharing intravenous drug users and through sexual 

contact, 14,23,48-51 but mother to child transmission of HTLV-II has recently been 

reported. 52 At least one-half of U.S. blood donors who confirm positive for antibody 

following HTLV-I screening have been identified as HTLV-II positive rather 

than HTLV-I positive. 23,28,38,44,53 

Neither HTLV-I nor HTLV-II cause acquired immunodeficiency syndrome (AIDS) 

and the HTLV-I and HTLV-II viruses are only remotely related to the AIDS virus, 

HIV. No cross-reactivity with antibodies to HIV-1 or HIV-2 has been demonstrated 

for this assay. The finding of antibodies to HTLV-I/HTLV-II by this assay has no 

relationship to the presence of antibodies to HIV and does not imply any risk of 

AIDS. 

The ABBOTT PRISM HTLV-I/HTLV-II assay has been developed to detect 

antibodies to HTLV-I and HTLV-II in human serum or plasma. This detection is 

accomplished through the presence of HTLV-I and HTLV-II viral antigens on the 

solid phase. The ABBOTT PRISM HTLV-I/HTLV-II assay does not discriminate 

between antibody reactivity to HTLV-I and HTLV-II. 

Specimens which are not reactive by the ABBOTT PRISM HTLV-I/HTLV-II assay 

are considered negative for antibodies to HTLV-I and HTLV-II. These specimens 

need not be tested further. Specimens which are initially reactive should be retested 

in duplicate. Reactivity in either or both of these duplicate tests (i.e., repeatedly 

reactive) is highly predictive of the presence of HTLV-I and/or HTLV-II antibodies in 

people at risk for HTLV infection. However, as for enzyme immunoassays, the 

ABBOTT PRISM HTLV-I/HTLV-II assay may yield non-specific reactions due to 

other causes, particularly when testing low prevalence populations (e.g., blood 

donors). A specimen which is found repeatedly reactive should be investigated 

further in supplemental tests, such as HTLV specific immunoassays, 9 

immunoblotting, immunoprecipitation assays, or a combination thereof. 

An HTLV-I, HTLV-II, or dual infection can only be differentiated serologically by 

parallel testing using antigens from HTLV-I and HTLV-II in specific 

immunoassays. 54,55 Tests based on reactivities to HTLV-I and HTLV-II type specific 

proteins may enable viral typing. Nonserologic tests based on the presence of 

infected cells, or HTLV-I/HTLV-II DNA probe testing [e.g., polymerase chain reaction 

(PCR)] may also be used in discrimination. 56 

2 

Recommendation for appropriate use of additional supplemental confirmatory and/ 

or differential tests may be issued periodically by the U.S. Public Health Service. 38,41 

BIOLOGICAL PRINCIPLES OF THE PROCEDURE 

The ABBOTT PRISM HTLV-I/HTLV-II assay is a three-step sandwich ChLIA. The 

reactions occur in the following sequence: 

• Microparticles coated with sonicated and detergent-inactivated HTLV-I and 

HTLV-II antigens are incubated with either plasma, serum, calibrator, or control 

(sample) in the incubation well of the reaction tray. During incubation, HTLV-I 

and/or HTLV-II antibodies present in the sample bind to the antigen on the 

Microparticles. 

• After this first incubation is complete, the reaction mixture is transferred to the 

glass fiber matrix (matrix) of the reaction tray using the Transfer Wash. The 

Microparticles are captured by the matrix, while the remaining mixture flows 

through to the absorbent blotter. 

• A Probe consisting of biotinylated HTLV-I and HTLV-II proteins is added to the 

Microparticles on the matrix and incubated. The Probe binds to the HTLV-I/ 

HTLV-II Microparticle-antibody complex created during the first incubation 

process. After the second incubation, the unbound Probe is washed into the 

blotter with Probe Wash. 

• The Acridinium-Labeled Anti-Biotin Conjugate is added to the Microparticles 

on the matrix to bind any Probe that is present. After the third incubation, the 

unbound Conjugate is washed into the blotter with the Conjugate Wash. 

• The chemiluminescent signal is generated by addition of an alkaline hydrogen 

peroxide solution and the resultant photons are counted. 

The amount of light emitted is proportional to the amount of anti-HTLV-I and/or 

anti-HTLV-II in the sample. For further information regarding ChLIA technology, 

refer to the ABBOTT PRISM Operations Manual, Section 3. The presence or 

absence of anti-HTLV-I/HTLV-II in the sample is determined by comparing the 

number of photons collected from the sample to a cutoff value determined from an 

ABBOTT PRISM calibration performed in the same batch. If the number of photons 

collected from a test sample is greater than or equal to the cutoff value, the sample 

is considered reactive for anti-HTLV-I and/or anti-HTLV-II. Specimens which are 

not reactive by the ABBOTT PRISM HTLV-I/HTLV-II assay are considered 

negative for anti-HTLV-I or anti-HTLV-II. These specimens need not be further 

tested. Specimens which are initially reactive should be centrifuged according to 

the table in the Specimen Collection and Preparation for Analysis section and 

retested in duplicate. 

REAGENTS 

NOTE: Each specific component description noted below is accompanied 

by a unique symbol. These symbols appear on both the component labels 

and on corresponding instrument tubing identifier labels. They are meant to 

facilitate identification and installation of reagent bottles within the ambient 

reagent bay and refrigerator. 

ABBOTT PRISM HTLV-I/HTLV-II Assay Kit (6A53-48) 

• 1 bottle (319 mL) HTLV-I/HTLV-II Antigen (Inactivated) 

Coated Microparticles in Phosphate Buffer with Tween ® * 20 and Protein 

Stabilizers. Preservative: Sodium Azide. (Symbol: ●) 

• 1 bottle (331 mL) Anti-Biotin (Mouse Monoclonal): Acridinium 

Conjugate in Phosphate Buffered Saline with Triton ®** X-100 and Protein 

Stabilizers. Minimum Concentration: 0.025 µg/mL. Preservative: Sodium Azide. 

(Symbol: ▲) 

• 3 bottles (10.4 mL each) Negative Calibrator (Human). Recalcified, 

Heat-Inactivated Plasma Nonreactive for HBsAg, HIV RNA or HIV-1 Ag, 

Anti-HCV, Anti-HIV-1/HIV-2, and Anti-HTLV-I/HTLV-II. Preservative: Sodium 

Azide. (Symbol: NC) 

• 3 bottles (10.4 mL each) HTLV-I Positive Calibrator (Human). 

Recalcified, Heat-Inactivated Plasma Reactive for Anti-HTLV-I, and Nonreactive 

for HBsAg, HIV RNA or HIV-1 Ag, Anti-HCV and Anti-HIV-1/HIV-2. HTLV-I 

Positive Calibrator may be cross-reactive for antibody to HTLV-II. Preservative: 

Sodium Azide. (Symbol: PC) 

• 3 bottles (10.4 mL each) HTLV-II Positive Assay Control (1) 

(Human). Recalcified, Heat-Inactivated Plasma Reactive for Anti-HTLV-II, 

Nonreactive for HBsAg, HIV RNA or HIV-1 Ag, Anti-HCV and Anti-HIV-1/HIV-2. 

HTLV-II Positive Assay Control (1) may be cross-reactive for antibody to HTLV-I. 

Preservative: Sodium Azide. (Symbol: PC2) 

• 1 bottle (324 mL) HTLV-I/HTLV-II Antigen (Inactivated) Biotinylated 

Probe. Biotinylated HTLV-I, HTLV-II, and HTLV-I Envelope Enriched Viral Lysate 

in TRIS Buffered Saline with Calf Serum and Protein Stabilizers. 

Preservative: ProClin ®*** 300. (Symbol: ■) 

ABBOTT PRISM HTLV-I/HTLV-II Wash Kit (6A53-38) 

• 1 bottle (3342 mL) Transfer Wash. Phosphate Buffered 

Saline. Preservative: Sodium Azide. (Symbol: ~) 

• 1 bottle (1725 mL) Conjugate Wash. MES 

{2-(N-morpholino)ethanesulfonic Acid} Buffered Saline. Preservative: 

ProClin 300. (Symbol: ★) 

* Tween is a registered trademark of ICI Americas. 

** Triton is a registered trademark of Union Carbide Co., Inc. 

*** ProClin is a registered trademark of Rohm & Haas.

• PROBE WASH 1 bottle (1718 mL) Probe Wash. TRIS Buffered Saline with 

Triton X-100. Preservatives: ProClin 300 and Sodium Azide. (Symbol: ➜) 

ABBOTT PRISM Activator Concentrate (1A75-02 or 3L27-02) 

• 4 bottles (900 mL each) Activator 

Concentrate. 0.4% Hydrogen Peroxide/0.06% Diethylenetriaminepentaacetic 

Acid. 

ABBOTT PRISM Activator Diluent (1A75-01 or 3L27-01) 

• 4 bottles (900 mL each) Activator Diluent. 0.3N 

Sodium Hydroxide. 

Other Reagents Available 

ABBOTT PRISM Run Control Kit (5E22-10) 

• 2 Bottles (10 mL each) Positive Control (Human). Purified 

anti-HBc IgG (Concentration: 0.9 - 2.6 PEI* Units/mL) and recalcified, 

heat-inactivated plasma reactive for HBsAg (HBsAg Concentration: 

0.10 - 0.40 ng/mL [0.01 - 0.05 PEI Units/mL]), anti-HCV, anti-HIV-1, and 

anti-HTLV-I. Preservative: Sodium Azide. (Symbol: POS) 

† Refer to NOTE listed at the end of this section. 

• 1 Bottle (10 mL) Supplemental Positive Control 

(Human). Recalcified, heat-inactivated plasma reactive for anti-HIV-2 and 

anti-HTLV-II, nonreactive for HBsAg and anti-HCV. Preservative: Sodium Azide. 

(Symbol: SUP) 

• 2 Bottles (10 mL each) Negative Control (Human). Recalcified 

plasma nonreactive for HBsAg, HIV RNA or HIV-1 Ag, anti-HBc, anti-HBs, 

anti-HCV, anti-HIV-1/HIV-2, and anti-HTLV-I/HTLV-II. Preservative: Sodium 

Azide. (Symbol: NEG) 

ABBOTT PRISM Positive Run Control Kit (5E22-11) 


anti-HBc IgG (Concentration: 0.9 - 2.6 PEI Units/mL) and recalcified, heatinactivated 

plasma reactive for HBsAg (HBsAg Concentration: 

0.10 - 0.40 ng/mL [0.01 - 0.05 PEI Units/mL]), anti-HCV, anti-HIV-1, and 



ABBOTT PRISM Run Control Kit (4B48-10) 

• 1 Bottle (20 mL) Positive Control (Human). Purified anti-HBc 

IgG (Concentration: 1.5 - 3.5 PEI Units/mL) and recalcified, heat-inactivated 

plasma reactive for HBsAg (HBsAg Concentration: 0.10 - 0.40 ng/mL [0.01 - 0.05 

PEI Units/mL]) and reactive for anti-HCV, anti-HIV-1 and anti-HTLV-I. 

Preservative: Sodium Azide. (Symbol: POS) 



(Human). Recalcified, heat-inactivated plasma reactive for anti-HIV-2, anti- 

HTLV-II, nonreactive for HBsAg and anti-HCV. Preservative: Sodium Azide. 

(Symbol: SUP) 

• 1 Bottle (20 mL) Negative Control (Human). Recalcified plasma 

nonreactive for HBsAg, HIV RNA or HIV-1 Ag, anti-HBc, anti-HBs, anti-HCV, 

anti-HIV-1/HIV-2, and anti-HTLV-I/HTLV-II. Preservative: Sodium Azide. 

(Symbol: NEG) 

ABBOTT PRISM Positive Control Kit (4B48-11) 



plasma reactive for HBsAg (HBsAg Concentration: 0.10 - 0.40 ng/mL 

[0.01 - 0.05 PEI Units/mL]) and reactive for anti-HCV, anti-HIV-1, and 



ABBOTT PRISM Run Control Kit (2K24-10) 

• 2 Bottles (10 mL each) Positive Control (Human). Purified anti- 

HBc IgG (Concentration: 0.9 - 2.6 PEI Units/mL) and recalcified, heat-inactivated 

plasma reactive for HBsAg (HBsAg Concentration: 0.10 - 0.40 ng/mL [0.01 - 

0.05 PEI Units/mL]), anti-HCV, anti-HIV-1, and anti-HTLV-I. Preservative: 

Sodium Azide. (Symbol: POS) 



(Human). Recalicified, heat-inactivated plasma reactive for anti-HIV-2 and 

anti-HTLV-II, nonreactive for HBsAg, HIV RNA or HIV-1 Ag, and anti-HCV. 

Preservative: Sodium Azide. (Symbol: SUP) 

• 2 Bottles (10 mL each) Negative Control (Human). Recalcified 

plasma nonreactive for HBsAg, HIV RNA or HIV-1 Ag, anti-HBc, anti-HBs, 

anti-HCV, anti-HIV-1/HIV-2, and anti-HTLV-I/HTLV-II. Preservative: Sodium 

Azide. (Symbol: NEG) 

* Concentration standardized against the reference standard of the Paul Ehrlich 

Institute (PEI), Langen, Germany. 

3 

ABBOTT PRISM Positive Run Control Kit (2K24-11) 



plasma reactive for HBsAg (HBsAg Concentration: 0.10 - 0.40 ng/mL 

[0.01 - 0.05 PEI Units/mL]), anti-HCV, anti-HIV-1, and anti-HTLV-I. Preservative: 

Sodium Azide. (Symbol: POS) 


† NOTE: Each batch MUST end in a release control. An anti-HTLV-I/HTLV-II 

release control is any control reactive for anti-HTLV-I and/or anti-HTLV-II which 

has been configured to validate system function and release sample results. 

The configuration criteria are defined in the RUN CONTROLS file of the ABBOTT 

PRISM Resource Management software. Any customer specified control 

reactive for anti-HTLV-I and/or anti-HTLV-II may be used. 

WARNINGS AND PRECAUTIONS 

For In Vitro Diagnostic use. 

CAUTION: This product contains human sourced and/or potentially 

infectious components. Components sourced from human blood have been 

tested and found to be nonreactive for HBsAg, HIV RNA or HIV-1 Ag, anti-HCV, 

and anti-HIV-1/HIV-2 by approved tests. Refer to the Reagents section of this 

package insert. No known test method can offer complete assurance that 

products derived from human sources will not transmit infection. Therefore, 

all human sourced material must be considered potentially infectious. It is 

recommended that all samples and kit reagents be handled in accordance 

with Biosafety Level 2 practices as described in the CDC NIH publication, 

Biosafety in Microbiological and Biomedical Laboratories 57 or other 

equivalent guidelines. 58,59 The HTLV-I and HTLV-II antigens have been 

inactivated by sonication and detergent-treatment prior to use. The HTLV-I 

Positive Calibrator and the HTLV-II Positive Assay Control (1) have been 

inactivated by heat treatment. 60 

Safety Precautions 

• Do not pipette by mouth. 

• Do not smoke, eat, drink, apply cosmetics, or handle contact lenses in areas in 

which samples or reagents are handled. 

• Wear disposable gloves when handling samples and reagents. 

• Clean and disinfect all spills of samples and reagents using a tuberculocidal 

disinfectant, such as 0.5% sodium hypochlorite. 61-63 

• Decontaminate and dispose of all samples, reagents and other potentially 

contaminated materials in accordance with applicable regulations. 64,66 Generally 

accepted procedures for the treatment of potentially infectious solid waste 

include incineration or autoclaving. Due to variations among autoclaves and in 

waste configuration, each user must verify the effectiveness of the 

decontamination cycle using biological indicators. 65 

• The ABBOTT PRISM Line Cleaner containing 2% Tetraethylammonium 

Hydroxide (TEAH) may cause mild eye irritation. If this solution comes in contact 

with eyes, rinse immediately with water (for additional information, refer to the 

ABBOTT PRISM Operations Manual, Section 8). 

• Some components of this product contain Sodium Azide. For a specific listing, 

refer to the Reagents section of this package insert. Sodium azide has been 

reported to form lead or copper azide in laboratory plumbing. These azides 

may explode upon percussion, such as hammering. To prevent formation of 

lead or copper azide, flush drains thoroughly with water after disposing of 

solutions containing sodium azide. To remove contamination from old drains 

suspected of azide accumulation, the National Institute for Occupational Safety 

and Health recommends the following: (1) siphon liquid from trap using a rubber 

or plastic hose, (2) fill with 10% sodium hydroxide solution, (3) allow to stand 

for 16 hours, and (4) flush well with water. 

• The components containing Sodium Azide are classified per the applicable 

European Community (EC) Directives as: Harmful (Xn). The following are the 

appropriate Risk (R) and Safety (S) phrases. 

R22 Harmful if swallowed. 

R32 Contact with acids liberates very toxic gas. 

S35 This material and its container must be disposed of in 

a safe way. 

S36 Wear suitable protective clothing. 

S46 If swallowed, seek medical advice immediately and 

show this container or label. 

• Probe Wash contains Sodium Azide and a mixture of: 5-chloro-2-methyl-4isothiazolin-3-one 

and 2-methyl-4-isothiazolin-3-one (3:1) (a component of 

ProClin) and is classified per the applicable European Community (EC) 

Directives as: Harmful (Xn). The following are the appropriate Risk (R) and 

Safety (S) phrases. 

R22 Harmful if swallowed. 

R32 Contact with acids liberates very toxic gas. 

R43 May cause sensitisation by skin contact. 


a safe way. 

S36/37 Wear suitable protective clothing and gloves. 


show this container or label.

• Conjugate Wash and Probe contain a mixture of: 5-chloro-2-methyl-4isothiazolin-3-one 

and 2-methyl-4-isothiazolin-3-one (3:1) (a component of 

ProClin) and is classified per applicable European Community (EC) Directives 

as: Irritant (Xi). The following are the appropriate Risk (R) and Safety (S) phrases. 

R43 May cause sensitisation by skin contact. 

S24 Avoid contact with skin. 


a safe way. 

S37 Wear suitable gloves. 



• The ABBOTT PRISM Activator Diluent contains Sodium Hydroxide and is 

classified per the applicable European Community (EC) Directives as: Irritant 

(Xi). The following are the appropriate Risk (R) and Safety (S) phrases. 

R36 Irritating to eyes. 

S26 In case of contact with eyes, rinse immediately with 

plenty of water and seek medical advice. 


a safe way. 



For product not classified as dangerous per European Directive 1999/45/EC 

as amended - Safety data sheet available for professional user on request. 

Handling Precautions 

• Do not use kits beyond the expiration date. 

• Gently invert each component several times prior to loading on the ABBOTT 

PRISM System to ensure a homogenous solution. Avoid foaming. Each 

component of the ABBOTT PRISM HTLV-I/HTLV-II Wash Kit should be at room 

temperature (15 to 30°C) before mixing. 

• Do not mix reagents from different bottles. Do not mix reagents from different 

assay kit lots. 

• Any lot of ABBOTT PRISM HTLV-I/HTLV-II Wash Kit can be used with any lot 

of ABBOTT PRISM HTLV-I/HTLV-II Assay Kit. 

• Avoid microbial and chemical contamination of samples, reagents, and 

equipment. The use of disposable pipette tips is recommended for any 

preliminary sample transfer. 

• Do not freeze reagents. 

• Failure to adhere to instructions in the ABBOTT PRISM Operations Manual or 

Package Insert may result in erroneous results. 

• Use caution when handling samples, reagent bottles, and reagent caps to 

prevent cross contamination. 

Additional safety and handling precautions and limitations for the assay kit, 

calibrators, specimens, controls, and other reagents are described in the ABBOTT 

PRISM Operations Manual, Section 7. 

PREPARATION OF ACTIVATOR SOLUTION 

Activator Solution is prepared daily by mixing equal parts of Activator Concentrate 

and Activator Diluent. The volume of Activator Solution required for multiple tests 

is calculated by the ABBOTT PRISM software. Refer to the ABBOTT PRISM 

Operations Manual, Section 5, under Plan Work Load, for additional information. 

Use clean pipettes and/or metal-free containers (such as plasticware or acidwashed 

and distilled or deionized water-rinsed glassware) to measure. Prepare in 

the bottle provided in the Accessory Kit. Cover the bottle opening securely with 

the cap provided and invert gently five to ten times to mix. Load the Activator 

Solution on the PRISM System. Refer to the ABBOTT PRISM Operations Manual, 

Section 5, under Prepare and Load Activator Solution, for additional information. 

NOTE: The Activator Solution must be used within 24 hours of preparation. 

STORAGE INSTRUCTIONS 

• Store the ABBOTT PRISM HTLV-I/HTLV-II Assay Kit, ABBOTT 

PRISM Run Control Kit, ABBOTT PRISM Positive Run Control 

Kit, and ABBOTT PRISM Activator Concentrate at 2 to 8°C. 

• Store the ABBOTT PRISM HTLV-I/HTLV-II Wash Kit and 

ABBOTT PRISM Activator Diluent at room temperature (15 to 

30°C). 

• Store ABBOTT PRISM Pipette Tips and ABBOTT PRISM 

Reaction Trays in their original package until use. 

INDICATIONS OF INSTABILITY OR DETERIORATION OF REAGENTS 

The ABBOTT PRISM System will not continue to process samples when calibrator 

or Positive Assay Control values do not meet specifications. This may indicate 

either deterioration or contamination of reagents, or instrument failure. Refer to 

the ABBOTT PRISM Operations Manual, Section 10, for additional information. 

INSTRUMENT PROCEDURE 

• Refer to the ABBOTT PRISM Operations Manual for a detailed description of 

Instrument Procedures. 

• Solutions required for instrument cleaning and maintenance are described in 

detail in the ABBOTT PRISM Operations Manual, Sections 5 and 9. 

• For optimal performance, it is important to follow the routine maintenance 

procedures defined in the ABBOTT PRISM Operations Manual, Section 9. 

4 

SPECIMEN COLLECTION AND PREPARATION FOR ANALYSIS 

• Either serum (including serum collected in serum separator tubes) or plasma 

collected in EDTA, Sodium Heparin, Potassium Oxalate, Sodium Citrate, ACD, 

CP2D, CPD, or CPDA-1 anticoagulants may be used with the ABBOTT PRISM 

HTLV-I/HTLV-II assay. 

• This assay was designed and validated for use with human serum or plasma 

from individual donor specimens. Pooled specimens must not be used. 

• Heat-inactivated specimens should be avoided. 

• Gravity separation is not sufficient for specimen preparation. Specimens 

collected by plasmapheresis which have not been frozen do not require 

centrifugation. All other specimens (including previously frozen plasmapheresis 

specimens) must be centrifuged. 

Non-frozen specimens (excluding non-frozen plasmapheresis specimens) must 

be centrifuged such that g-minutes (the product of relative centrifugal force [RCF] 

and centrifugation time [minutes]) is between 30,000 and 75,000. The following 

chart lists acceptable time and force ranges that meet this criteria. 

Time RCF x Time 

(minutes) RCF (x g) (g-minutes) 

10 3,000 30,000 

15 2,000 - 3,000 30,000 - 45,000 

20 1,500 - 3,000 30,000 - 60,000 

25 1,300 - 3,000 32,500 - 75,000 

Convert rpm to RCF as follows: RCF = 1.12 rmax (rpm/1000) 2 

Convert RCF to rpm as follows: rpm = 1000 x RCF 

�1.12 x rmax RCF - The relative centrifugal force generated during centrifugation. 

rpm - The rotation per minute of the rotor on which the specimens are being 

spun (usually the digital readout on the centrifuge will indicate rpm). 

Time - The time should be measured from the time the rotor reaches the 

required RCF or rpm to the time it begins decelerating. 

rmax - Radius of the rotor in millimeters. The radius measured is dependant 

on whether the rotor is a fixed angle rotor or a swinging bucket rotor. 

This value is typically provided with the rotor, by the manufacturer. 

g-minutes - the unit of measure for the product of RCF (x g) and time (minutes). 

NOTE: For fixed angle, rmax is a measure of the distance from the rotor axis 

(center) to the bottom of the tube cavity. For the swinging bucket, rmax is a measure 

of the distance from the rotor axis (center) to the bottom of the tube bucket while 

it is extended during rotation. 

Previously frozen specimens must be centrifuged such that g-minutes (the 

product of relative centrifugal force [RCF] and centrifugation time [minutes]) is 

between 180,000 and 300,000. The following chart lists acceptable time and force 

ranges that meet this criteria. 

Time RCF x Time 

(minutes) RCF (x g) (g-minutes) 

15 12,000 180,000 

20 9,000 - 12,000 180,000 - 240,000 

25 7,200 - 12,000 180,000 - 300,000 

ANY specimen (excluding non-frozen plasmapheresis) not tested within 24 hours 

of initial centrifugation, must be recentrifuged from 30,000 to 75,000 (g-minutes) 

as defined for non-frozen specimens. 

NOTE: If re-testing a specimen within 24 hours of initial centrifugation, the specimen 

is not required to be re-centrifuged. 

FAILURE TO FOLLOW THE SPECIFIED CENTRIFUGATION PROCEDURE MAY 

GIVE ERRONEOUS OR INCONSISTENT RESULTS. 

• Specimens may be stored at 2 to 8°C for up to fourteen days. If storage periods 

greater than fourteen days are anticipated, the serum or plasma should be 

removed from the clot or red blood cells to avoid hemolysis. Store the serum or 

plasma frozen (-10°C or colder). 

• Previously frozen specimens must be mixed thoroughly after thawing and 

centrifuged according to the table in this section. 

• Although 10 nonreactive and 10 low-level reactive specimens showed no 

qualitative performance differences when subjected to 6 freeze-thaw cycles, 

multiple freeze-thaw cycles should be avoided. 

NOTE: Some specimens nonreactive for anti-HTLV-I and/or anti-HTLV-II that 

have been subjected to frozen storage have exhibited non-specific reactivity in 

the ABBOTT PRISM HTLV-I/HTLV-II assay. 

• Clear, non-hemolyzed specimens should be used when possible. Specimens 

containing particulate matter may give erroneous or inconsistent test results. 

• No qualitative performance differences were observed when nonreactive and 

low-level reactive specimens (plasma CP2D) were tested with elevated levels 

of bilirubin (≤ 20 mg/dL), hemoglobin (≤ 500 mg/dL), and lipids (≤ 3,000 mg/dL).

• When shipped, specimens must be packaged and labeled in compliance with 

applicable regulations covering the transport of clinical specimens and etiologic 

agents. Specimens may be shipped under ambient conditions, refrigerated on 

wet ice (2 to 8°C), or frozen on dry ice (-10°C or colder). Prior to freezing, the 

specimen should be removed from the clot or red cells. 

• Performance has not been established for cadaver specimens, umbilical cord 

blood, or body fluids such as urine, saliva, semen, amniotic fluid, cerebrospinal 

fluid, or pleural fluid. 

Specimen Volume 

The specimen volume required to perform a single assay on the ABBOTT PRISM 

System varies according to the different specimen containers. For ABBOTT PRISM 

Sample Cups, the minimum specimen volume required for one assay is 400 µL. 

The ABBOTT PRISM HTLV-I/HTLV-II Assay requires 100 µL sample dispense. 

For volume requirements for each additional assay performed from the same 

specimen container and for volume requirements in primary or aliquot tubes, refer 

to the ABBOTT PRISM Operations Manual, Section 5. 

ABBOTT PRISM HTLV-I/HTLV-II PROCEDURE 

Materials Provided 

• 6A53-48 ABBOTT PRISM HTLV-I/HTLV-II Assay Kit 

• 6A53-38 ABBOTT PRISM HTLV-I/HTLV-II Wash Kit 

Materials Required but not Provided 

• 1A75-02 or 3L27-02 ABBOTT PRISM 


• 5A07-01 ABBOTT PRISM 


• 6A36-60 ABBOTT PRISM Accessory Kit 

Additional Materials Available 


• 2K24-10 ABBOTT PRISM Run Control Kit 

2K24-11 ABBOTT PRISM Positive Run Control Kit 

• 4B48-10 ABBOTT PRISM Run Control Kit 

4B48-11 ABBOTT PRISM Positive Control Kit 

• 5E22-10 ABBOTT PRISM Run Control Kit 

5E22-11 ABBOTT PRISM Positive Run Control Kit 





• 7B36-01 ABBOTT PRISM 

ABBOTT PRISM ASSAY PROCEDURE 

For detailed information concerning batch time and maximum batch size, 

refer to the ABBOTT PRISM Operations Manual, Section 2. 

STEP 1: 

• Enter a Plan Workload (refer to ABBOTT PRISM Operations Manual, Section 5). 

• Replace reagents as needed. 

NOTE: Gently invert each component several times prior to loading on the 

ABBOTT PRISM System to ensure a homogenous solution. Additional gentle 

inversion may be required to thoroughly resuspend microparticles. Avoid 

foaming. Each component of the ABBOTT PRISM HTLV-I/HTLV-II Wash Kit 

should be at room temperature (15 to 30°C) before mixing. 

• Verify that all tubing label symbols match the symbols on each reagent label. 

(Refer to the symbol key in the Reagents section.) 

• Verify that all tubing is securely fastened to the corresponding wash and 

reagent bottles. 

STEP 2: 

• Inspect the waste containers. Empty and clean as defined in the ABBOTT 

PRISM Operations Manual, Section 9, if necessary. 

STEP 3: 

• Prepare Activator Solution (refer to the Preparation of Activator Solution section 

of this package insert) and load into the ABBOTT PRISM System. 

STEP 4: 

• Verify adequate number of Reaction Trays are in the Tray Loader. 

5 

STEP 5: 

• Verify adequate number of Pipette Tips are in the Pipette Tip Racks. 

STEP 6: 

• Perform the prime procedure (refer to the ABBOTT PRISM Operations Manual, 

Section 5). 

STEP 7: 

• Initiate sample processing. Open the bottles in the Calibrator/Positive Assay 

Control Pack and place in the Calibrator Rack and Sample Racks, including 

the Controls (refer to the Control Handling Procedure, under Controls). 

STEP 8: 

• After the Calibrators and Positive Assay Control have been pipetted, remove 

Calibrator Rack. Close the Calibrator/Positive Assay Control bottles and return 

to 2 to 8°C storage. 

STEP 9: 

• Each sample is initially tested once. Sample Racks may be removed after the 

samples have been pipetted. 

STEP 10: 

• Any specimen (excluding non-frozen plasmapheresis) that is initially 

reactive must be centrifuged according to the table in the Specimen 

Collection and Preparation for Analysis section and retested in duplicate 

(refer to the ABBOTT PRISM Operations Manual, Section 5). 

NOTE: Specimen retested within 24 hours of initial centrifugation do not require 

recentrifugation. 

STEP 11: 

• After the run is complete, perform the purge procedure (refer to the ABBOTT 

PRISM Operations Manual, Section 5). 

Refer to the ABBOTT PRISM Operations Manual, Section 3, for a detailed 

description of ChLIA procedures. 

QUALITY CONTROL PROCEDURES 

Calibration 

The ABBOTT PRISM HTLV-I/HTLV-II Negative and Positive Calibrators and the 

HTLV-II Positive Assay Control (1) are tested in triplicate automatically at the 

beginning of each batch. The ABBOTT PRISM System will not release results 

when Calibrator or Positive Assay Control values do not meet specifications. This 

may indicate either deterioration or contamination of reagents, or instrument failure. 

Controls 

1. A release control MUST be included as the last sample in each batch. A control 

such as the ABBOTT PRISM Positive Control or any customer-specified control 

reactive for anti-HTLV-I and/or anti-HTLV-II may be used. This control must 

test reactive in order to validate system functionality and to release results. If 

this control does not test reactive, refer to the ABBOTT PRISM Operations 

Manual, Section 10. 

Sites using a release control other than the ABBOTT PRISM Positive Control 

must validate its performance on the ABBOTT PRISM System. 

2. ABBOTT PRISM Run Control Handling Procedure 

a. Place each Run Control bottle into an adapter such that when the flip-top 

cap is opened, it can be snapped into an open position within the adapter. 

b. Place each Run Control within an adapter onto the Sample Rack. The 

controls can be placed in any rack position except 1, 2, 27, or 28. 

c. As mentioned above, place an ABBOTT PRISM Positive Control after the 

last sample tested in the batch. The controls can be placed in any rack 

position except 1, 2, 27, or 28. 

3. Customer-Specified Control Handling Procedure 

a. Determine the volume of controls required. The control volume required 

to perform a single assay on the ABBOTT PRISM System varies according 

to the different specimen containers. For ABBOTT PRISM Sample Cups, 

the minimum control volume required for one assay is 600 µL (400 µL + 

200 µL Sample Cup dead volume). For every additional assay performed 

from the same control container, an additional 200 µL is required. For 

volume requirements in primary or aliquot tubes, refer to the ABBOTT 


b. Refer to the ABBOTT PRISM Operations Manual, Section 5: Operating 

Instructions, Subsection: Sample Processing. 

4. Additional controls may be run at the operator’s discretion. Validity specifications 

may be assigned such that if these controls fail, no results are reported for that 

assay batch. 

ASSAY PARAMETER SPECIFICATIONS 

The PRISM assay parameter specifications have been factory set. These 

parameters cannot be printed, displayed, or edited.

RESULTS 

Calculation of Cutoff and S/CO Values 

The ABBOTT PRISM System calculates the ABBOTT PRISM HTLV-I/HTLV-II 

assay cutoff value using the following formula: 

Cutoff = Mean Negative Calibrator Net Counts 

+ (0.15 x Mean Positive Calibrator Net Counts)* 

Example: If the Mean NCC = 1,100, and the Mean PCC = 6,900, 

1,100 + (0.15 x 6,900) = 2,135 

Cutoff = 2,135 

* The Positive Calibrator, HTLV-II Positive Assay Control (1), and Negative 

Calibrator Mean Net Counts are calculated using the two lowest replicates. An 

Instrument Code (02-211) will be displayed in place of the count value for the 

third replicate. Each of the two remaining replicates of the Positive Calibrator 

and the Negative Calibrator used to calculate the cutoff must meet all 

specifications. 

The ABBOTT PRISM System calculates the ABBOTT PRISM HTLV-I/HTLV-II assay 

S/CO using the following formula: 

S/CO = Sample Net Counts ÷ Cutoff 

Example: If the Sample Net Counts = 3,000, and the Cutoff = 2,135, 

3,000 ÷ 2,135 = 1.41 

S/CO = 1.41 

INTERPRETATION OF RESULTS 

In the ABBOTT PRISM HTLV-I/HTLV-II assay, specimens with Net Counts less 

than the cutoff value are considered nonreactive and need not be tested further. 

Specimens with Net Counts greater than or equal to the cutoff value are considered 

initially reactive. All specimens that are reactive on initial testing must be centrifuged 

according to the table in the Specimen Collection and Preparation for Analysis 

section of this package insert and retested in duplicate. 

NOTE: If re-testing a specimen within 24 hours of the initial centrifugation, the 

specimen is not required to be re-centrifuged. 

If repeat testing shows the Net Counts for both retests to be less than the cutoff 

value, the specimen is nonreactive. If the Net Counts of either retest are greater 

than or equal to the cutoff value, the specimen is repeatedly reactive. Repeatedly 

reactive specimens should be investigated further by supplemental tests such as 

immunoblots, immunoprecipitation or immunofluorescent assays. 

ABBOTT PRISM reports display sample results in Net Counts and/or S/CO. Net 

Counts are used by ABBOTT PRISM to interpret results. The S/CO value is provided 

in reports to show relative reactivity to the cutoff value. In the ABBOTT PRISM 

HTLV-I/HTLV-II assay, specimens with S/CO values of less than 1.00 are considered 

nonreactive. Specimens with an S/CO value of greater than or equal to 1.00 are 

considered reactive. 

For details on configuring the ABBOTT PRISM System to use Grayzone 

Interpretations, refer to the ABBOTT PRISM Operations Manual, Section 2. 

READING RESULTS 

Some S/CO values may be flagged with "" symbols. Refer to the ABBOTT 


SYSTEM ERRORS 

For a description of the error codes that appear in the ABBOTT PRISM Report, 

refer to the ABBOTT PRISM Operations Manual, Section 10. 

LIMITATIONS OF THE PROCEDURE 

• Testing of previously frozen samples with the ABBOTT PRISM HTLV-I/HTLV-II 

assay may cause an increase in non-specific reactivity. 

• The ABBOTT PRISM HTLV-I/HTLV-II assay does not discriminate between 

HTLV-I and HTLV-II antibody reactivity. 

• This assay was designed and validated for use with human serum or plasma 

from individual patient and donor specimens. Pooled specimens must not be 

used since the accuracy of their test results has not been validated. 

• It is recommended that repeatedly reactive specimens be investigated by 

supplemental testing. Individuals who are repeatedly reactive should be referred 

for medical evaluation which may include additional testing. 

• False reactive results can be expected with any test kit. Falsely elevated results 

have been observed due to non-specific interactions (see Table II). 

• Performance has not been established for body fluids other than serum or 

plasma. 

• Previously frozen specimens must be centrifuged per the Specimen Collection 

and Preparation for Analysis section of this package insert prior to running the 

assay. 

• Serum from heparinized patients may be incompletely coagulated. Erroneous 

or inconsistent results may occur due to the presence of fibrin. To prevent this 

phenomenon, draw specimen prior to heparin therapy. 

• The use of specimens with obvious microbial contamination should be avoided. 

• Although the association of infectivity and the presence of anti-HTLV-I/HTLV-II 

is strong, it is recognized that presently available methods for 

anti-HTLV-I/HTLV-II detection are not sensitive enough to detect all potentially 

infectious units of blood or possible cases of HTLV-I/HTLV-II infection. 

6 

• The interpretation of results of specimens found repeatedly reactive by the 

ABBOTT PRISM HTLV-I/HTLV-II assay and negative or indeterminate on 

additional supplemental testing is unclear. Further clarification may be obtained 

by testing another specimen from the same patient taken 3 to 6 months later. 

EXPECTED RESULTS 

In a random population of 6,678 volunteer blood donor specimens, four (0.06%) 

were reactive by the ABBOTT PRISM HTLV-I/HTLV-II assay. Among 148 

preselected anti-HTLV-I positive and 148 preselected anti-HTLV-II positive 

specimens, the ABBOTT PRISM HTLV-I/HTLV-II assay detected 100.00% as 

repeatedly reactive. 

SPECIFIC PERFORMANCE CHARACTERISTICS 

Precision 

Assay reproducibility was determined by assaying a 28 member panel consisting 

of four replicates each of three diluted specimens reactive for anti-HTLV-I (panel 

members 1, 2, and 3), three diluted specimens reactive for anti-HTLV-II (panel 

members 4, 5, and 6) and one specimen nonreactive for anti-HTLV-I or anti-HTLV-II 

(panel member 7). The panel was tested in five runs over five days with each of 

three master lots at a total of three sites. 

The intra- and inter-run standard deviation (SD) and percent coefficient of variation 

(%CV) were analyzed with a variance components analysis, using a nested analysis 

of variance model67 (Table I). 

Mean S/CO is defined as the mean sample net counts (NET) divided by the 

calculated Cutoff. 

TABLE I 

ABBOTT PRISM HTLV-I/HTLV-II 

Assay Reproducibility 

Number of Mean Intra-run Inter-run* 

Panel Member Replicates S/CO SD %CV SD %CV 

1 120 8.27 0.339 4.1 0.487 5.9 

2 118 5.19 0.240 4.6 0.291 5.6 

3 114 3.17 0.131 4.1 0.190 6.0 

4 119 6.90 0.291 4.2 0.446 6.5 

5 120 3.98 0.180 4.5 0.254 6.4 

6 119 2.35 0.096 4.1 0.138 5.9 

7 120 0.56 0.026 4.7 0.033 5.9 

Negative Control 240 0.42 0.031 7.3 0.035 8.3 

Positive Control 178 2.02 0.114 5.7 0.142 7.0 

Supplemental 

Positive Control 

240 1.84 0.097 5.3 0.115 6.3 

Number of Mean Intra-run Inter-run* 

Calibrators Replicates NET SD %CV SD %CV 

Negative 180 833 50.1 6.0 82.8 9.9 

Positive 179 7,208 292.6 4.1 485.6 6.7 

Supplemental 

Positive 

180 6,179 273.5 4.4 438.2 7.1 

* This term includes intra-run variability. 

Specificity 

The specificity of the ABBOTT PRISM HTLV-I/HTLV-II assay was estimated 

assuming a zero prevalence of HTLV-I and/or HTLV-II in volunteer blood donors 

and plasmapheresis donors. 

A total of 6,678 serum and plasma specimens from volunteer blood donors and 

plasmapheresis donors was collected from four blood centers (Table II). Of the 

four repeatedly reactive specimens one was excluded as confirmed positive by 

DBL HTLV-I/II Western Blot, RIPA-I, and/or RIPA-II. a Therefore, of the 6,677 

donations presumed seronegative for anti-HTLV-I and anti-HTLV-II, ABBOTT 

PRISM HTLV-I/HTLV-II had an estimated specificity of 99.96% (6,674/6,677) with 

a 95% confidence interval of 99.87% to 99.99%. 

Specimens from individuals with medical conditions unrelated to HTLV-I and/or 

HTLV-II infection or containing potentially interfering substances and specimens 

from random hospital patients were tested with the ABBOTT PRISM HTLV-I/HTLV-II 

assay (Table II). 

a A confirmed positive result was defined by the presence of antibodies to two gene 

products (gag p24 and env gp46 or gp61/67) using Western Blot and/or RIPA.

TABLE II 

Reactivity in Donor Populations, in Random Hospital Patients, 

and in Specimens from Individuals with Medical Conditions Unrelated to 

HTLV Infection or Containing Potentially Interfering Substances 

ABBOTT PRISM Number of 

HTLV-I/HTLV-II ABBOTT PRISM 

HTLV-I/HTLV-II 

Repeatedly 

Reactive 

Number Initially Repeatedly Specimens 

of Speci- Reactive Reactive that were 

mens n (%) n (%) Confirmed 

Group/Type Tested (95% CI) (95% CI) Positivea (%) 

Volunteer Serum 3,089 0 (0.00) 0 (0.00) 

Blood Plasma 3,081 3 (0.10) 2 (0.06) 0 (0.00) 

Donors 

Plasmapheresis 508 2 (0.39) 2 (0.39) 1 (50.00) 

Donors 

TOTAL DONORS 6,678 5 (0.07) 4 (0.06) 1 (25.00) 

(0.02-0.17) (0.02-0.15) 

Random Hospital 

Patients 

300 13 (4.33) 13 (4.33) 6 (46.15) 

Medical Conditions 

Unrelated to HTLV 

Infection and 

Potentially Interfering 

Substancesb 

622 22 (3.54) 19d (3.05) 1 (5.26)c 

a A confirmed positive result in these studies was defined by the presence of antibodies 

to two gene products (gag p24 and env gp46 or gp61/67) using Western Blot and/or 

RIPA. 

b "Medical Conditions Unrelated to HTLV Infection and Potentially Interfering Substances" 

included the following categories of fresh and previously frozen specimens: ANA Ab 

Positive, Rheumatoid Factor Positive, SLE, CMV Ab Positive, EBV Ab Positive, HAV 

Ab Positive, HBsAg Positive, Recovered HBV Infection, HIV-1 Ab Positive, HIV-2 Ab 

Positive, HCV Ab Positive, HSV Ab Positive, Rubella Ab Positive, Mycoplasma Ab 

Positive, Multiple Myeloma, Syphilis Positive, Toxoplasma Ab Positive, Fungal Infections, 

Animal Handlers, Elevated Immunoglobulin, Elevated Bilirubin, Elevated Triglycerides, 

Elevated Cholesterol, Elevated Hemoglobin, Goat/Mouse Ab Positive, Multiparous 

Females, Multiple Transfusion Recipients, Vaccine Recipients, and Biotin Positive. 

c One CMV Ab Positive specimen confirmed positive for HTLV-II. 

d Out of 61 EBV Ab Positive specimens, 6 were repeatedly reactive with the ABBOTT 

PRISM HTLV-I/-II assay, but not confirmed. 

Detectability 

Preselected anti-HTLV-I positive and preselected anti-HTLV-II positive specimens 

and populations at increased risk of HTLV infection were tested with the ABBOTT 

PRISM HTLV-I/HTLV-II assay. The ABBOTT PRISM HTLV-I/HTLV-II assay detected 

all of the 299 confirmed positive specimens (100.00%) (Table III). 

TABLE III 

Reactivity of the ABBOTT PRISM HTLV-I/HTLV-II Assay in 

Preselected Populations with HTLV Infection or at Increased Risk 

of HTLV Infection 

Supplemental Assay 

Results 

Number Number Con- 

Repeatedly firmed Posi- 

Reactive by tive that are 

Number ABBOTT Number ABBOTT 

of Speci- PRISM Con- PRISM 

mens HTLV-I/HTLV-II firmed HTLV-I/HTLV-II 

Group Tested (%) Positive Reactive (%) 

Preselected 148 148 (100.00) 148 148 (100.00) 

Anti-HTLV-I 

Positive Populations 

Preselected 148 148 (100.00) 148 148 (100.00) 

Anti-HTLV-II 

Positive Populations 

Populations at 99 3 (3.03) 3 3 (100.00) 

Increased Risk of 

HTLV Infectiona 

TOTAL 395 299 (75.70) 299 299 (100.00) 

a "Populations at Increased Risk of HTLV Infection" included: U.S. IV Drug Users and 

Hemodialysis Patients. 

7 

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