WO1997016714A1

WO1997016714A1 - Multifunction valve

Info

Publication number: WO1997016714A1
Application number: PCT/IB1996/001172
Authority: WO
Inventors: Norman K. Parker; James E. Rasmussen; Richard L. Schulkind; Kevin J. Sullivan; Robert B. Green
Original assignee: Chiron Diagnostics Corporation
Priority date: 1995-11-02
Filing date: 1996-10-31
Publication date: 1997-05-09
Also published as: EP0858588A1; EP0858588B1; US5750906A; AU7327096A; DE69602851D1; DE69602851T2

Abstract

The invention features a sample probe and reagent selector valve that enables selection among multiple functions of withdrawing a biological sample from a syringe or capillary into a fluid parameter sensor module, providing calibration and quality control reagents to the sensor module, and flowing a washing fluid through intake passages to prevent cross-contamination and clogging. The valve sensor module are used in conjunction with an automated analytical instrument, such as an automated blood analyzer, to increase the speed of the analysis, minimize cross-contamination between samples, and to overcome the inherent dangers of using the conventional needle/syringe or capillary methods of withdrawing fluids to be tested. The design of the valve provides performance benefits in the form of lower sample and reagent waste volumes, elimination of auxiliary valves and manifolds, and superior performance and reduced cost.

Description

MULTIFUNCTION VALVE

FIELD OF THE INVENTION

This invention relates to sample handling valves, and more particularly to

combination reagent selection and sample probe valves for an automated instrument.

BACKGROUND OF THE INVENTION

A variety of methods are currently available to deliver a fluid sample to the

analysis section of an instrument. In the case of liquid biological samples, syringes

are often used to manually inject the sample into a sample receiving port on the

instrument and into the analytical components ofthe instrument. Although simple,

this method suffers from several disadvantages. In particular, the inconsistency of

human control used to inject the sample causes variations between operators, between

samples injected by the same operator, and throughout the injection motion ofa single

sample. These inconsistencies frequently result in different sample sizes being

injected, and hence inconsistent analytical results. Proper injection technique using a

syringe thus requires proper training and adequate time to master. Another significant problem with manual syringe injection is contamination of

the sample. When a syringe is used, the needle is generally pushed through a septum

or other seal prior to injection into the instrument. If the septum is contaminated with

materials from previous injections, the composition ofthe sample that is currently

being analyzed could be tainted and result in cross-contamination between samples.

Under heavy use, septa are also liable to becoming clogged with residual material

from previous samples. One method to alleviate sample contamination is to manually

wash the syringe and injector, and recalibrate the instrument. However, this method is

tedious and time-consuming and itself not always consistent.

Laboratory safety has become a significant consideration recently, particularly

with the threat of blood-borne diseases, such as hepatitis and AIDS. Use of a

conventional syringe and needle increases the risk of exposing the laboratory

technicians to infected blood through accidental skin puncture. In addition, careless

disposal of the contaminated syringe and/or needle can result in exposure of other

laboratory and maintenance personnel to blood-borne diseases.

Uptake of a sample by a capillary is an alternative method over manual

syringe injection. However, special robotic-type equipment must often be attached to

the instrument in order for a sample to be drawn into the capillary and transported to

the analyzer. Capillaries also require manual cleaning between samples, and must be

replaced at regular intervals to maintain performance consistency and sample quality. Ideally, an injection and sampling system should reproducibiy and repeatedly inject

samples into an analyzer instrument with minimal cross contamination between

samples. The injection and sampling system should also be able to recalibrate the

instrument automatically and be able to choose from a variety of standardization

reagents to match the composition ofa variety of samples.

U.S. Patent Nos. 5,372,782 and 5,39,499 to Karkantis et al. disclose automated

sampling devices. However, these devices are limited in the number of

standardization reagents that may be chosen.

SUMMARY OF THE INVENTION

The invention features a sample probe and reagent selector valve that performs

the multiple functions of withdrawing a liquid biological sample from a syringe or

capillary, providing calibration and quality control reagents to the sensor module, and

washing itself to prevent cross-contamination and clogging. The valve is used in

conjunction with an automated analytical instrument, such as an automated blood

analyzer, to increase the speed ofthe analysis, minimize cross contamination between

samples, and to overcome the inherent dangers of using the conventional

needle/syringe or capillary methods of injection. The design ofthe valve provides

performance benefits in the form of lower sample and reagent waste volumes,

elimination of auxiliary valves and manifolds, and superior performance and reduced

cost. The invention thus features a sample probe and selector valve that includes a

lower valve body, an upper valve body, and a sample probe movably positioned

between the upper and lower valve bodies. The sample probe is positioned in a

channel molded into the upper and lower valve bodies when the upper and lower

valve bodies are assembled together. The sample probe moves linearly within the

channel to permit the selective uptake of either a sample, a wash solution or foam, or

quality control or calibration reagents.

The lower valve body includes two or more inlet ports that permit calibration

or quality control reagents to flow into the analytical section ofthe device. The

sample probe takes the form of a tube sealed at one end and includes two apertures

located on the walls ofthe tube, similar to the arrangement found in a basketball

filling needle. One aperture is located adjacent to the sealed end of the sample probe,

and the second aperture is located between the first aperture and the opposite open

end. The distance between the two probe apertures is such that when the second

aperture aligns with any one ofthe inlet ports on the lower valve body, the first

aperture is sealed by the two halves of the valve. Similarly, when the first aperture is

positioned beyond the first end ofthe valve, the second aperture becomes sealed

between the two halves ofthe valve. Thus, as the valve body and sample probe move

relative to each other, the apertures on the sample probe are either sealed or in the

appropriate positions for uptake of a sample, washing ofthe sample probe, or uptake

of calibration or quality control reagents. The invention also features a combination sample input collector and wash

chamber attached to the front ofthe multifunction valve. The sample input collector

includes a fitting designed to accept a container containing a sample to be analyzed;

for example a syringe or capillary containing a sample of blood, urine, or other

biological sample. A washing solution or foam is provided by a pump to a wash port

and channel formed in the lower valve body and connected to the wash chamber.

Thus, the multifunction valve ofthe invention also features a position in which

the tip and interior ofthe sample probe may be washed between samples. According

to the invention, when the tip ofthe sample probe is positioned within the wash

chamber, washing solution or foam is pumped into the wash chamber and flows

around the outside ofthe sample probe. Simultaneously, the wash solution can be

aspirated into the sample probe to clean the interior ofthe sample probe and analyzer

between analyses.

The multifunction valve of the invention also features a position in which

reagents, such as calibration, quality control, or other reagents, may be transported

into the analysis section ofthe instrument. According to the invention, when the

second aperture ofthe sample probe is aligned with a selected one ofthe inlet ports, a

quality control or calibration reagent may be aspirated into the analytical section of

the instrument to affect calibration and/or quality control ofthe instrument between

samples. In this position, the first aperture is sealed between the upper and lower

valve bodies to prevent the calibration or quality control reagents from escaping the 5 valve. An additional position is present which allows for quality control reagents to

be aspirated using the first aperture while the second aperture is sealed. This position

allows for automatic aspiration of quality control reagent in a manner consistent with

the aspiration of samples.

l o The invention also encompasses an analytical instrument that uses the

multifunction valve described above. In the analytical instrument, the multifunction

valve is attached to pumps, reagent containers, and motion and control apparatus to

move the multifunction valve. The pumps include a first pump to aspirate the sample

into the analytical instrument and a second pump to provide wash solution to the

15 combination sample input collector and wash chamber. Reagent containers are

connected to the input ports on the lower valve body to provide calibration or quality

control solutions to the instrument. Thus, the multifunction valve of the invention

functions as a major control point in the automated analysis of biological material.

20 DESCRIPTION OF THE DRAWINGS

The invention will be more fully understood from the following detailed

description taken in conjunction with the accompanying drawings in which:

Fig. 1 is an exploded view ofthe multifunction valve of the invention;

Fig. 2A is a top view ofthe lower valve body ofthe invention;

25 Fig. 2B is a side view ofthe lower valve body of the invention;

Fig. 2C is a bottom view ofthe lower valve body ofthe invention;

Fig. 3 is a bottom view ofthe upper valve body of the invention; Fig. 3 A is a bottom view of an alternative embodiment ofthe upper valve

body of the invention;

Fig. 4 is a side view ofthe sample probe ofthe invention;

Fig. 5 is a diagram of the multifunction valve ofthe invention in the

"sampling" position;

Fig. 6 is a diagram ofthe multifunction valve ofthe invention in the "wash"

position;

Fig. 7 is a diagram ofthe multifunction valve ofthe invention in the "reagent

uptake" position;

Fig. 8 A is a diagram ofthe motion and control apparatus associated with the

multifunction valve ofthe invention in the "sampling" position;.

Fig. 8B is a diagram ofthe motion and control apparatus associated with the

multifunction valve of the invention in the "wash" position; and

Fig. 8C is a diagram ofthe motion and control apparatus associated with the

multifunction valve ofthe invention in the "reagent uptake" position.

DETAILED DESCRIPTION OF THE INVENTION

Fig. 1 shows an exploded overview ofthe multifunction valve 10 of the

invention. The multifunction valve 10 comprises an upper valve body 12, a lower

valve body 14, and a sample probe 16. The lower valve body includes a lower

groove 18 formed along its longitudinal axis, and the upper valve body includes an

upper groove 20 formed along its longitudinal axis. The upper valve body 12 and the

lower valve body 14 are fit together and the respective grooves 18 and 20 in each

valve body form a channel in which the sample probe 16 is positioned. The sample

probe 16 is capable of sliding within the channel and thus permits the multifunction

valve to operate. The halves ofthe multifunction valve are held together by snap

action clamps or other attachment devices. Recesses 48 are used to accurately align

the upper valve body 12 and the lower valve body 14 when assembled together.

As illustrated in Fig. 1, the lower valve body 14 includes a plurality of inlet

ports 22 formed in the groove 18. The inlet ports 22 permit the multifunction valve to

be coupled to a variety of solutions, such as quality control or calibration reagents that

are utilized during the analysis cycle. A vent aperture 24 is positioned along the

groove 18 and ahead ofthe inlet ports 22 to allow the valve to vent to the atmosphere

or allow quality control or standardization reagents to be automatically aspirated into

the instrument. The vent aperture permits uptake of air between samples and provides

a method of cleaning the interior ofthe sample probe by meniscus surface tension. A

wash port 26 is positioned near the front end 28 ofthe lower valve body. A

channel 30 permits wash fluid to flow from the wash port 26 to the front end 28 of the valve body. An elbow channel 31 is formed in the lower valve body 12 between the

groove 18 and the front end 28. The elbow channel 31 allows for a drain port at the

bottom ofthe sample input collector and wash chamber 54 to eliminate residual fluid,

improve washing and permit venting ofthe system.

Referring again to Fig. 1, the sample probe 16 fits into the channel foimed by

the respective grooves 18 and 20 when the two halves of the multifunction valve are

assembled. The sample probe 16 is an elongated tube and includes an open end 32

and a sealed end 34. The sample probe 16 is capable of sliding in the channel to affect

the multiple functions ofthe valve, such as sample uptake, wash, or reagent uptake.

In the sample probe, a sample aperture 36 is located on the wall ofthe probe

adjacent to the sealed end 34 in an arrangement similar to that found on the needle

valves that fill footballs, basketballs and the like. A reagent aperture 38 is located on

the wall of the sample probe between the sample aperture 36 and the open end 32.

The relative distance between the sample aperture 36 and the reagent aperture 38 is

such that when the reagent aperture 38 aligns with any one ofthe inlet ports 22 on the

lower valve body, the sample aperture 36 is sealed by the two halves ofthe valve, and

when the sample aperture 36 is positioned beyond the front end 28 of the valve, the

reagent aperture 38 becomes sealed between the two halves ofthe valve. Similarly,

when the sample aperture 36 is aligned with the vent aperture, the reagent aperture 38

is sealed between the two valve bodies. Thus, as the assembled valve bodies move

relative to the sample probe 16, the apertures 36, 38 are either sealed or in the appropriate positions for uptake of a sample, washing of the sample probe, or uptake

of calibration or quality control reagents. In one embodiment, the probe is stationary

and the valve body (and sample) are moveable. Alternatively, the sample probe can

be moved and the valve body held stationary.

Fig. 2A shows the upper face 40 of the lower valve body 14 in more detail.

The lower valve body 14 can be made of any flexible material, such as rubber,

neoprene, or similar polymer known in the art, that is capable of forming a seal

between itself and the interconnections and sample probe described herein below.

The upper face 40 ofthe lower valve body 14 includes a groove 18 running

longitudinally along its entire length. Located in the groove are a plurality of inlet

ports 22 that permit a plurality of reagents to flow into the interior ofthe valve body.

The reagents may be quality control reagents, calibration reagents, or other chemical

reagents known in the art. It is also possible to conduct chemical reactions in the

sample probe if the appropriate reagents are supplied throughout the inlet ports 22.

The plurality of inlet ports permits the chosen reagents to be selected and dispensed at

the appropriate time in the analytical procedure. The inlet ports have a diameter less

than the inner diameter ofthe sample probe and preferably in the range of 20-80% of

the sample probe diameter.

As shown in Fig. 2B, the inlet ports 22 are accessible to the groove 18 by a

plurality of inlet tubes 42 formed in the valve body 14 with one tube being associated

with each port. The inlet tubes allow reagents to flow into the sample probe 16 if the reagent aperture 38 is aligned with one ofthe inlet ports. While the reagent

aperture 38 is aligned with a selected inlet port, the sample aperture 36 is sealed by

the flexible material of the valve bodies as described in more detail below.

As shown in Figs. 2B and 2C, the vent aperture 24 is also connected to the

groove 18 by a vent inlet tube 44. The vent inlet tube 44 may be connected to a

source of gas, such as pressurized air, nitrogen, argon, etc. to provide a gas source to

the sample probe. Inlet tube 44 may also be connected to a reagent delivery system

capable of delivery quality control reagents such that the system can perform

automatic quality control procedures. Alternatively, the vent aperture may be vented

to the atmosphere to provide a space between consecutive samples. Wash port 26 is

connected to the groove 18 by a wash inlet tube 46, and permits the wash port to be

connected to a pump that will provide wash solution or foam when the sample probe

is to be washed.

It will be appreciated that while the embodiment shown in Fig. 2 illustrates the

invention with four reagent inlet ports 22, other numbers of reagent inlet ports, such as

2, 3, 5, 6, 10, or more may be foimed in the lower valve body 14, and that the number

of reagent inlet ports may be determined empirically by one skilled in the art.

Fig. 3 illustrates a bottom view ofthe upper valve body 12. The upper valve

body 12 includes a groove 20 that runs longitudinally along its entire length to guide

the probe during operation. A wash channel 30' is foimed to run parallel to the groove 20 and terminate at the front end 50 ofthe upper valve body 12. Similarly, a

complementary elbow channel 31' is foimed to run from the groove 20 to the front

end 50. Recesses 48 are formed in the upper valve body to allow for alignment ofthe

upper valve body to the lower valve body and seal in the sample probe 16 within the

channel. Alternatively, as shown in Fig. 3A, the upper valve body may be comprised

of two individual sections. This embodiment includes a front elastomeric guide

section 12' which includes a channel 20, elbow channel 31', wash channel 30' and

recesses 48 similar to the arrangement found in Fig. 3. A front section 12" is

positioned in front ofthe front elastomeric guide section 12' and covers the groove

and probe during operation. The front section 12 may be made from any solid bearing

material that is capable of sealing the probe within the channel.

Fig. 4 illustrates the sample probe 16 ofthe invention. In one embodiment, the

sample probe 16 is a hollow tube comprising a sealed end 34 and an open end 32. A

sample aperture 36 is located adjacent to the sealed end and is foimed into the side

wall ofthe sample probe 16. The sample aperture 36 functions to take samples into

the sample probe when that portion ofthe sample probe is positioned in a sample

container. The sealed end 34 permits the sample probe to be moved within the

assembled valve bodies 12, 14 and allows the sample aperture 36 to be sealed within

the valve as the sample probe 16 is withdrawn into the assembled valve bodies.

A reagent aperture 38 is foimed into the side wall ofthe sample probe between

the sample aperture 36 and the open end 32. The reagent aperture 38 permits reagents to How into the sample probe 16 when the reagent aperture is aligned with any one of

the reagent inlet ports 22. The distance between the sample aperture 36 and the

reagent aperture 38 is such that when the reagent aperture 38 aligns with any one of

the inlet ports 22, the sample aperture 36 is sealed, and when the sample aperture 36 is

positioned beyond the front end 28 ofthe valve, the reagent aperture 38 becomes

sealed.

The sample probe may be made of any material that does not react with the

biological sample or any ofthe reagents or washing solutions used in the invention.

Such materials include surgical stainless steel, teflon, or other nonreactive materials.

In one embodiment, the sample probe is made of surgical stainless steel with an inner

diameter of approximately 0.002 inch and apertures 36, 38 have a diameter of

approximately 0.017 inch. In general, the thickness ofthe probe tube wall is less than

the probe port diameter so that the port does not form a "blind pocket" which could be

a source of cross-contamination of successive samples.

As indicated above, the groove 20 formed in the upper valve body 12 aligns

with the groove 18 formed in the lower valve body 14 when the two valve bodies are

attached together. The resulting channel formed by the two grooves 18 and 20 has the

proper dimensions to fit the sample probe 16 and to allow the sample probe 16 to

move longitudinally therewithin. In addition, the dimensions ofthe resulting channel

are such that the apertures 36, 38 located in the sample probe 16 are capable of being

sealed when they are not aligned with any inlet port. Fig. 5 illustrates the multifunction valve 52 of the invention connected to

devices that enable the multifunction valve to operate in conjunction with other

components in an analyzer. In the exemplary embodiment illustrated in Fig. 5, the

multifunction valve 52 includes a combination sample input collector and wash

chamber 54 attached to the front of the assembled valve bodies. The sample input

collector 54 includes a fitting 56 designed to accept a container 58 containing a

sample to be analyzed; for example a syringe or capillary containing a sample of

blood, urine, or other liquid biological sample. The fitting 56 forms a seal with the

container 58 so that no sample is spilled during sample uptake by sample probe 16.

The sample input collector and wash chamber 54 further comprises a

chamber 60 in which wash solution or foam is supplied to wash the sample probe 16

between uptake of samples. A wash pump 62 is connected by a supply line 64 to the

wash inlet tube 46. A supply of wash solution or foam is pumped through the wash

port 26 and channel 30 and into the chamber 60 when the sample probe 16 is in the

"wash" position.

The open end 32 ofthe sample probe is connected by a tube 66 to the

analytical section 68 ofthe instrument. The analytical section includes any device

that analyzes biological samples, for example, dissolved gas sensors, ion slective

electrodes, or metabolyte sensors. During sample uptake, a sample pump 70 aspirates a portion of the sample

material into the sample probe and tubing and moves it through the device. Waste

material is expelled from the sample pump 70 after the analytical measurements are

obtained. This arrangement allows a single pump to draw the selected sample through

the sensor module without cross-contamination of the sample sources.

The multifunction valve 52 is connected by tubes 71 to reagent bottles 73.

Each tube 71 is attached to a respective inlet tube 42 to provide a selected reagent to

the multifunction valve. The reagent bottles 73 include reagents (denoted as R,, R₂,

R₃, and R₄), such as calibration reagents, quality control reagents, standardization

reagents, reaction reagents, or any other solution useful in the analytical device. The

reagents contained in the reagent bottles 73 are accessible to the multifunction

valve 52 when the reagent aperture 38 is aligned with a selected reagent inlet port 22.

Although Fig. 5 is illustrated with four reagent sources (R_rR₄), any number of

reagent sources may be utilized.

Referring again to Fig. 5, the multifunction valve ofthe invention is illustrated

in the "sampling" position. In this position, a syringe 58 is attached to the fitting 56 to

provide a biological sample to be analyzed. The sealed end 34 and the sample

aperture 36 are positioned beyond the fitting 56 to enter the syringe 58. In this

position, the reagent aperture 38 is not aligned with any ofthe inlet ports 22. Rather,

the reagent aperture 38 in the sample probe is blocked by the wall of the valve body,

thus preventing contamination ofthe blood sample by the other reagent sources. Therefore, the sample 72 is free to move into the analytical section 68 ofthe

instrument without contamination.

Pump 70 aspirates a sample through sample aperture 36 and into the sample

probe. Once a sufficient and known volume of sample is taken into the sample probe

and the analytical measurement is made, the valve bodies move to withdraw the tip

into the input collector and wash chamber 54. This position is the "wash" position

and is illustrated in Fig. 6. Alternatively, the sample probe can be positioned to align

the sample aperture 36 with vent aperture 24 to allow an air bubble to be drawn into

the sample probe. The bubble is useful as a break between samples of differing

composition. As the bubble moves through the flow path, the meniscus at the

interface ofthe sample and the air produce a wiping action which essentially removes

the residue ofthe previous sample.

Referring now to Fig. 6, the sample probe 16 is withdrawn so that the sealed

tip 34 and sample aperture 36 are positioned within the input collector and wash

chamber 54. In this position, the sample probe tip can be washed with an air/reagent

wash foam generated by a pump 62 and delivered through the wash port 26 in the

valve body. The foam can be aspirated into the sample probe 16 by the sampling

pump 70, thereby washing residual biological material sample from the tip and the

inside ofthe sample probe. As the wash foam is aspirated through the instrument, it

washes the tube 66 as well as the analytical section ofthe sensor 68. In the wash position, the reagent aperture 38 is sealed by the valve bodies in this position so that

the reagents are not contaminated by the wash foam.

Referring now to Fig. 7, the multifunction valve is illustrated in the "reagent

uptake" position. In this position, the sample probe 16 is retracted into the valve, and

the reagent aperture 38 is positioned to align with a selected one ofthe reagent inlet

ports 22. Each reagent inlet port is connected to a reagent container containing a

specified reagent, such as a quality control reagent, calibration reagent,

standardization reagent, or reaction reagent. Some exemplary reagents include, but

are not limited to, pH buffer solutions, glucose solutions, or a standard protein

solution. Fig. 7 is illustrated with a single reagent container attached to the

multifunction valve for clarity. However, it will be appreciated that any number of

reagent containers can be selected by adding reagent inlet ports to the valve, as long as

the valve body between the first reagent inlet port and the input/wash area 54 is long

enough to block the reagent aperture 38 in the sampling position, and to block the

sample aperture 36 in the reagent uptake position. In the reagent uptake position, the

sample aperture 36 is sealed by the valve bodies to prevent reagents from entering the

input collector and wash chamber 54 and contaminating the samples.

During reagent uptake, the sampling pump 70 aspirates a volume of reagent

into the sample probe through the reagent aperture 38. The reagent travels along

tube 66 to the analytical section 68 where calibration and/or quality control

measurements are made. Following this procedure, the reagent is expelled to waste. Referring now to Fig. 8, the multifunction valve ofthe invention is illustrated

in three positions and connected to a motive apparatus 80 and a control module 82.

Fig. 8 includes the multifunction valve of the invention 52, a motor 80, such as a

stepper motor or other motor, and a control module 82, such as a computer. The

control module 82 is capable of instructing the motor to move the valve body relative

to the sample probe according to the operational cycle desired by the operator. The

control module 82 is also capable of controlling the pumps 70, 62 to aspirate reagents

or uptake samples.

Fig. 8A shows a diagram ofthe invention in the "sampling" position. The

motor is connected to the multifunction valve body by control arms 84 which position

the valve so that the sealed tip 34 ofthe sample probe is exposed and ready to accept a

sample. The control module 82 can also instruct the sampling pump 70 to take in a

sample. In Fig. 8B, the control module instructs the motor to move the valve body so

that the sealed tip 34 is located in the wash chamber 54. At this point, the control

module will activate the pumps 62, 70. The wash pump 62 is instructed to dispense

wash foam or solution into the wash chamber, and the sampling pump is instructed to

take up the wash solution to clean the interior of the sample probe. In Fig. 8C, control

module again instructs the motor 80 to move the valve body so that the sealed tip 34 is

located in valve body. At this point, the reagent aperture is aligned with a reagent

inlet port, and the sample pump is instructed to take up a volume of reagent. Thus,

the valve body is moved as the sample probe is retained in a stationary position. Alternatively, it is possible to retain the valve body in a stationary position and move

the sample probe using the motor 80, control arms 84 and control module 82. Thus,

the desired valve position may be easily selected by the user to perform the desired

operation.

Although the invention has been shown and described with respect to an

illustrative embodiment thereof, it should be appreciated that the foregoing and various

other changes, omissions, and additions in the form and detail thereof may be made

without departing from the spirit and scope ofthe invention as delineated in the claims.

Claims

CLAIMSWe claim:

1. A multifunction valve, comprising:

a lower valve body, comprising

a first end, a second end, a top face, and a bottom face;

an upper valve body, comprising

a first end, a second end, a top face, and a bottom face, said upper valve

body attached to said lower valve body to form a seal, said seal sealing said sample

probe in said groove; and

a groove positioned on said top face and between said first end and said second

end of at least one of said valve bodies;

a plurality of inlet ports positioned on at least one of said bottom faces, said

plurality of inlet ports having corresponding apertures communicating with said groove;

a sample probe movably positioned in said groove, and comprising

a sealed end and an open end adapted to receive a conduit of a fluid test

system; and

a first aperture located adjacent said sealed end, and a second aperture

located between said first aperture and said open end;

wherein when said second aperture of said sample probe aligns with one of said

plurality of inlet ports to expose an inlet port to said open end, said first aperture of said

sample probe is sealed by said upper valve body and said lower valve body, and when

said first aperture of said sample probe is positioned beyond said first end of said lower

valve body to permit penetration into a sample holder for access from said open end, said second aperture of said sample probe is sealed by said upper valve body and said

lower valve body.

2. The multifunction valve of claim 1, further comprising a sample input collector

attached to said first end at least one of said valve bodies, said sample input collector

having a chamber to receive said sample probe and having a holder to receive a

container containing a sample to be analyzed.

3. The multifunction valve of claim 2, further comprising a wash port and flow

slot, said wash port and said flow slot formed on said top face of at least one of said

valve bodies and connected to said chamber of said input collector.

4. The multifunction valve of claim 1, wherein at least one of said plurality of inlet

ports is connected to a calibration reagent.

5. The multifunction valve of claim 1 , wherein at least one of said plurality of inlet

ports is connected to a quality control reagent.

6. The multifunction valve of claim 1 , wherein at least one of said plurality of inlet

ports is open to the atmosphere.

7. The multifunction valve of claim 1 , further comprising a pump and a sensor

module attached to said open end of said sample probe.

8. The multifunction valve of claim 2, wherein said multifunction valve has a

sample uptake position wherein said first aperture of said sample probe is positioned

beyond said sample input collector, and said second aperture is sealed by said upper

valve body and said lower valve body.

9. The multifunction valve of claim 2, wherein said multifunction valve has a wash

position wherein said first aperture of said sample probe is positioned within said

chamber of said sample input collector, and said second aperture is sealed by said upper

valve body and said lower valve body.

10. The multifunction valve of claim 2, wherein said multifunction valve has a

calibration position wherein said second aperture of said sample probe aligns with one

of said plurality of inlet ports and said first aperture of said sample probe is sealed by

said upper valve body and said lower valve body.

11. An instrument to analyze samples of biological material, comprising:

the multifunction valve of claim 1 ;

a first pump and a sensor module attached to said open end of said sample probe;

a second pump connected to a wash port;

at least one reagent container, each of said at least one reagent container

connected to a corresponding one of each of said plurality of inlet ports; and

motion and control apparatus to move said multifunction valve.

12. The instrument of claim 11, wherein said multifunction valve has a sample

uptake position wherein said first aperture of said sample probe is positioned beyond

said sample input collector, and said second aperture is sealed by said upper valve body

and said lower valve body.

13. The instrument of claim 1 1, wherein said multifunction valve has a wash

valve body and said lower valve body.

14. The instrument of claim 1 1, wherein said multifunction valve has a calibration

position wherein said second aperture of said sample probe aligns with one of said

plurality of inlet ports and said first aperture of said sample probe is sealed by said upper

valve body and said lower valve body.

15. The instrument of claim 11, wherein said instrument analyzes biological

material.

16. The instrument of claim 15, wherein said biological material is blood.

17. The instrument of claim 15, wherein said biological material is urine.