Point of Care Rh testing

[adiescast]

Has anyone had any experience with using point of care Rh testing to determine RhIg candidacy?

This is the abstract that was provided to me in support of using this test:

Determining the accuracy of a rapid point-of-care test for determining Rh(D) phenotype.

Herold TJ, Whittaker DS, Glynn T.

MAJ, MC, Department of Emergency Medicine, Darnall Army Community Hospital, 36000 Darnall Loop, Fort Hood, TX 76544-4752, USA. HeroldTJ64@aol.com

Abstract

OBJECTIVES: To determine the sensitivity, specificity, and accuracy of a point-of-care method for identifying Rh(D) phenotype.

METHODS: Rh(D) was determined using preserved whole blood via standard laboratory methods. Comparison testing was conducted using the HealthTEST Rh(D) card (Akers Laboratories, Thorofare, NJ). Results of the card test were visually interpreted and recorded. To achieve sensitivity and specificity of 99% (95% confidence interval [CI] = 98% to 100%), 380 Rh-positive and 380 Rh-negative samples were required. During card testing, convenience sampling was used. Card results were compared with official results, and statistical analysis was conducted.

RESULTS: In identifying Rh(D)-positive phenotype, the card had a sensitivity of 98.9% and a specificity of 99.7% (95% CI = 0.99 +/- 0.01). For Rh(D)-negative phenotype, the card had a sensitivity of 99.7% and a specificity of 98.9% (95% CI = 0.99 +/- 0.01).

CONCLUSIONS: In identifying type D (Rh positive or Rh negative), the card achieves sensitivity, specificity, and accuracy to warrant further study.

PMID: 15860702 [PubMed - indexed for MEDLINE]

[Bill]

According to the Akers Labs website, the Blood Type Card is not available in the US. It looks interesting though.

[Liz]

I am just wondering where this would be used.

[Liz]

I mean I prefer Blood Bank results and RhIg does not need to be given STAT. If the results are wrong and RhIg is given, it won't harm but it is awfully expensive. What about the FMH and KB test..for the # of vials to administer. I agree with glucose POC. I dont even get the cholesterol POCT.

[Fluffy agglutinates]

I'm with Liz on this one - not sure I see how it would be useful with respect to the other testing already in place. In the UK the woman's RhD status is known from around 12 weeks into the pregnancy. As RhD isn't the only result required for complete antenatal monitoring why would you do this as POCT? (i.e. you still need to know the ABO group & antibody screen result so this is where RhD typing fits - if it ain't broke don't fix it...)

[dgibaud]

I can see application of this test in places that treat women who do not get much prenatal care (low income areas, planned parenthood centers, remote rural areas) where you might see them once and not again. There are other unique situations where patients might present where you don't have blood bank support.

Don

[AMcCord]

I can see application of this test in places that treat women who do not get much prenatal care (low income areas, planned parenthood centers, remote rural areas) where you might see them once and not again. There are other unique situations where patients might present where you don't have blood bank support.

Don

...and you have physicians in the PreOp who already know the patient's Rh type 'GOSH DARN YOU' and they want RhoGAM NOW and they don't want their patient stuck again (apparently that is the worst thing in the world that can happen to them) and all that other workup stuff your policy says you (the lab) have to do is baloney cause it ain't necessary. :mad::mad::mad: While everyone is shouting and your medical director is going through channels to deal with the tantrum, you have to - somehow - make sure that the patient is properly taken care of! I could see using a card test as a screen, to at least take care of business in the best interests of the patient until the dust settles and cooler heads prevail. Anyone else know physicians like that?

[Fluffy agglutinates]

I can see application of this test in places that treat women who do not get much prenatal care (low income areas, planned parenthood centers, remote rural areas) where you might see them once and not again. There are other unique situations where patients might present where you don't have blood bank support.

Don

Even in these areas you speak of surely it would still make more sense to do ABO/Rh (& ideally an antibody screen) together? It doesn't take long!

Out of interest what sort of situation might require anti-D prophylaxis without blood bank support? As Liz says it is not required 'stat' so why rush an important decision?

To me this is a commercial company trying to promote an unnecesary product with the added downside of fracturing tests that go perfectly together for a very good reason.

Edited January 4, 2011 by Fluffy agglutinates

[dgibaud]

Say a patient arrives at your urgent care medical center in downtown Chicago and reports that she just aborted in her apartment bathroom. She's seeing you to make sure she's not going to bleed anymore, but she's adamant that she won't go to the hospital that's 40 blocks away because she can't afford the cabfare, and her "boyfriend" doesn't want to wait. She doesn't know her blood type, and neither do you. She just needs to get back home. No previous records are availble. You know if you draw a sample and send it to the hospital for verification, it will probably take over an hour.

Similar situation, Dutch Harbor Alaska. You've got a medical center, but the nearest hospital is hours away by plane. A storm is raging outside and you have a patient that might be a rhogam candidate. Do you wait for the storm to subside? Or...just do a quickie screen, give the rhogam, and be safe. Granted, these are unique situations, but these sound like a perfect job for a POC blood type. I'm sure there are more.

[Fluffy agglutinates]

Fair enough but you do have 72 hrs to administer the treatment, plenty of time to get results back from the hospital or for the patient to get the bus to the hospital. In my opinion if the patient won't consider/ accept correct treatment then it is their responsibility to accept the consequences. I wouldn't want to rely on a different test just because they can't be bothered to hang around.

Of course this is easier for me to say as we have free healthcare!

[MAGNUM]

Why would anyone in our profession accept such a test? If it such an urgent item or the patient cannot wait, why not provide the urgent care center laboratory with the materials (anti-D reagent) and training on the proper performance of the the test.

[Bill]

Why would anyone in our profession accept such a test? If it such an urgent item or the patient cannot wait, why not provide the urgent care center laboratory with the materials (anti-D reagent) and training on the proper performance of the the test.

If the FDA approves the test, it most likely will be as a POC CLIA waived test. The current ABO/Rh laboratory tests are CLIA Moderate complex tests and cannot be performed in most urgent care centers. This also would be a good compliment to limited tests during natural disasters.

[Mabel Adams]

So what is the sensitivity/specificity of tube D typing? Wouldn't want to miss any Rh negs that need RhIG. Miscarriage (or threatened) in an unreliable population seems like the only half-way reasonable application for this. If they aren't responsible we all pay the costs.

And yes, free health care would probably have made the difference in a case I saw ofr a homeless woman that was having repeated bleeding but left the ER AMA without RhIG because she was concerned about costs. By term she had a high enough titer of anti-D to have to deliver as a high risk pregnancy in a bigger town 2 hours away. I am sure she had no more money then so it was charged to charity care which means all of us with insurance made up the difference. And the costs were surely higher for the complications.

[Liz]

yes it has been and still is that we have up to 72 hours to give the RhIG. However the literature states that we have up to seven. This is a reassurance in case of a delay.

Moreover, I wonder who keeps RhIG if they are so far off from a Blood Bank, but it is possible. Anything is possible.

[galvania]

I know it's way off the point but I think it's a really sad indictment of so-called rich countries that people have to go without ESSENTIAL health care through lack of money

[Fluffy agglutinates]

I don't think it's way off at all. It's a very valid point. It also bugs me that commercial companies are continuing to create unnecessary extra ways of performing standard tests just to eke out a few pennies more from a crippled healthcare system.

Consider that Third world blood banks don't even have consistent power supplies to run their centrifuges! Sorry - bit of a rant there! (and now I'm definitely off-topic...better be on my way:sprint:)

[LABKING]

Our ER wants to give the Rhogam just based on the Rh result.

and the reason is the same as above, many patients want to get instant

reassurance and get on the way.

So what is the hospital's transfusion service's fiduciary duty when the Dr wants to give Rhig and let the patient go.

Is the type and screen necessary.

Does the patients gestation come into effect. Like less than 20 weeks, 13 weeks, etc.

What is the ER physicians duty as to instruction to the patient in regards to prenatal care and the event of Rh-sensitization and positive clinical significant antibody identification.

I work in a large Texas hospital system with ER and L&D. we also would like to just "give and go" the Rhig to L&D antenatal outpatients with DR office T&S results.

Thank you for any comments.

[Bill]

Fluffy... the lack of consistant power is all the more reason for a quality point of care solution.

[Ajac]

I think it will be a while before the US will see this type of product because of FDA requirements for diagnostic tests. Interesting, however, is a rapid ABORh test was recently cleared, but can only be used for information and education. Cannot be used for transfusion or dispensing of Rh immune globulin as far as I could tell by reading the FDA page. (see Micronics ABORH card)

[Mabel Adams]

Great. An ABO test that can be used by thugs to intimidate their exes by implying that the baby isn't really theirs. I have seen that done with current testing. And they don't understand that 2 A parents can have an O baby. They even have ideas like "the baby has to have the blood type of one of the parents."

I guess those that want to "Eat Right for their Type" might want to use it--naturopaths and such.

[tbostock]

The thought of any Blood Bank test done as Point of Care scares me. I guess I can understand the practical reason for wanting it, but when I need a blood type done, please do it in a Blood Bank that understands what QC is, parallel testing, using the reagent before expiration, etc. But that's just me...maybe I'm just looking for job security...hahaha

[EDibble]

Teri, I echo your sentiments exactly. I am more and more certain as time goes on that laboratorians have a different type of brain than nursing staff. So many of these folks just "don't get it" and cut corners when doing POC testing. Thank goodness our QA supervisor oversees the POC in our hospital.

[Liz]

We too have our QA super check the POCT.

I was wondering, what tests do most of your medical centers cover with the POCT?

[EDibble]

I know for certain that they do glucose and PT/INR testing.

[EDibble]

Whoops! That is Terri, not Teri.